Novavax Jobs

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Senior Benefits Manager
Novavax 4.8
Novavax Job In Maryland Or Remote
If you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place. Individually, we're skilled, driven, and confident risk-takers. Collectively we're collaborative and accomplished. We're SuperNovas! Together we use our unique experiences, cultures, and learnings to turn innovation into reality while maintaining the highest standards. We value balance, encourage growth, and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you! Novavax, Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery, development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world's most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research, has tremendous potential to make a substantial contribution to public health worldwide. If you find science, speed, and success exhilarating, you have come to the right place. Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world's most pressing infectious diseases. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide. Our scientists are committed to developing vaccine candidates for some of the world's toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases. Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden. JOB SUMMARY The Senior Benefits Manager is responsible for supporting the design, implementation, and ongoing administration of employee benefits programs. This role includes ensuring benefits programs are aligned with the company's overall business strategy, competitive in the marketplace, compliant with legal requirements, and effectively communicated to employees. The individual will be responsible for the administration of a wide range of benefit programs. This job is based in the United States and offers flexibility for a remote work arrangement with an onsite presence once per week. JOB RESPONSIBILITIES The Senior Benefits Manager is expected to be able to perform under limited supervision and with independent decision-making the certain key responsibilities including, but not limited to:Benefits Administration Monitor benefits utilization and effectiveness of benefits offering across the region and provide advice on improvements and adjustments that may be needed. Periodically benchmark existing benefits to ensure they are competitive, cost effective, of high quality and are equitably offered. Collaborate with HR leadership and other key stakeholders, including finance, legal, and compliance teams, to ensure benefits strategy is aligned with overall organizational goals and objectives. Investigate and resolve any benefits-related issues that arise, including disputes with providers, miscommunications about plan coverage, and issues related to claims or benefits eligibility. Manage leave of absence programs, such as FMLA and other locally required leave policies. Contribute to the annual benefits renewals and leading/supporting annual benefits open enrollment. Collaborate with People Operations, Legal, and Finance teams to establish or discontinue benefits programs. Well-Being and Engagement Develop clear and impactful communication strategies to promote benefits programs and improve employee understanding. This includes creating accessible materials such as benefits guides, FAQs, videos, and hosting informational sessions or webinars. Collaborate with team members for a unified approach to global wellbeing and offer support to international partners regarding benefits and wellbeing resources. Work with healthcare and wellness providers to design programs, incentives, and informational content aimed at controlling benefits costs by promoting healthier employee behaviors. Partner with internal and external partners to gather insights on employee utilization of benefits programs and provide recommendations for improvements. Support communication strategies for global benefit offerings, utilizing effective channels to enhance impact and understanding. Communicate country-specific benefits details to employees and hiring managers by contributing to localized offer letters, onboarding materials, conducting benefits orientations, updating the intranet, and supporting wellness initiatives. Lead efforts to collect employee feedback on benefits offerings through surveys, focus groups, and other methods to assess satisfaction and identify areas for enhancement. Take action on feedback to improve the benefits program. Systems Ensure seamless integration of benefits programs with other HR systems (such as HRIS and payroll) across regions, focusing on streamlining benefits enrollment, automating communications, and maintaining secure and accurate data. Improve data accuracy in relevant systems and integrations by conducting internal audits and addressing any data discrepancies. Run eligibility extracts, create queries, and generate audit reports while troubleshooting issues in collaboration with IT and Payroll teams. Utilize tools for benefits analytics, forecasting, budgeting, and billing reconciliation to optimize program management and financial tracking. Vendor Relationship Management Oversee the vendor selection process for benefits providers (such as insurance companies, retirement plan administrators, and wellness service providers). Build and maintain strong partnerships with external vendors to negotiate advantageous contracts and ensure excellent service delivery. Assess contracts, service agreements, and benefit materials for accuracy and regulatory compliance. Continuously assess vendor performance and cost-effectiveness, ensuring timely contract renewals and improvements where needed. Other Responsibilities: Stay up to date on compliance updates and requirements. Update policies and programs to align with any regulatory changes. Analyze current and developing legislation, privacy, healthcare regulations and other environmental factors impacting plan performance and program competitiveness. Monitor changes in the regulatory environment by partnering with ERISA counsel, attending professional conferences and workshops, reviewing professional publications, establishing personal networks, and participating in professional societies. Communicate and implement changes necessary to remain compliant. Complete all necessary compliance reporting and notification requirements. Develop and implement a benefits communication strategy, collaborating with HR, Legal, and Corporate Communications teams. Create and deliver effective communications that help employees understand the value of the organization's benefits program. Oversee and validate enrollment and plan changes. Ensure work is completed in a timely manner to meet payroll and other district schedules and deadlines. Assist our Benefits Analysts when they need expert advice to implement changes and solve problems. Work on Special Projects and other related duties as assigned. MINIMUM QUALIFICATIONS 4-year Bachelor's degree in a relevant field A minimum of 12 years of progressive experience in benefits, including global/international health plans, required A minimum of 3 years directly involved with leading benefits, or similar experience Extensive working knowledge of general business and HR practices with strong understanding of Human Resources programs, processes and data is required High-level proficiency with Workday, Microsoft Office; Communicates effectively; strong and engaging facilitator Ability to compile, analyze, interpret, and present employee information and data accurately and with attention to detail Ability to organize work and follow-up skills are critical to the successful performance of position responsibilities Critical thinker with strong time-management, organization, and prioritization skills to meet deadlines Ability to operate independently in an ambiguous environment and handle complex employee issues with sensitivity and high level of confidentiality is required. Strong interpersonal skills and demonstrated ability to communicate effectively, verbally and in writing, across all levels of the organization Must be flexible and a strong team player Sound public speaking skills is required Ability to identify and resolve problems in a timely manner and gather and analyze information skillfully PREFERRED QUALIFICATIONS Professional Certification preferred (CEBS, PHR, SPHR, etc.) Experience in the Pharmaceuticals industry is a plus The annual base salary (or hourly wage) for this position falls within the range of $123,100.00 - $160,050.00. However, the actual base pay offered may vary based on several individualized factors, such as market location, job-related knowledge, skills, and experience. Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.Equal Opportunity Employer/Veterans/Disabled Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.
$123.1k-160.1k yearly 8d ago
Senior Director, Clinical Quality Assurance
Novavax 4.8
Remote Novavax Job
If you find science, speed, and helping address serious infectious diseases exhilarating, you have come to the right place. Individually, we're skilled, driven, and confident risk-takers. Collectively we're collaborative and accomplished. We're SuperNovas! Together we use our unique experiences, cultures, and learnings to turn innovation into reality while maintaining the highest standards. We value balance, encourage growth, and recognize that you are our most important asset. Build your future with us while bringing innovative vaccines to the world. We have a place for you! Novavax, Inc (Nasdaq:NVAX) is a biotechnology committed to helping address serious infectious diseases globally through the discovery, development and delivery of innovative vaccines to patients around the world. We have more than a decade of experience contending with some of the world's most devastating diseases, and we are here to make a difference. Hard-won lessons and significant advances illustrate that our proven technology based on solid science tested by decades of research, has tremendous potential to make a substantial contribution to public health worldwide. Job Summary We are seeking a Sr. Director, Clinical Quality Assurance to join our Clinical Quality Assurance department in Gaithersburg, MD. The incumbent will provide leadership and collaborate with required functional areas to ensure compliance with applicable Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP) and Good Clinical Laboratory Practices (GCLP) regulations as well as any additional applicable regulatory requirements. The incumbent is expected to build and maintain cross-functional relationships with key functional areas including but not limited to: Clinical Operations, Pharmacovigilance, and Regulatory Affairs. This position reports to the Vice President, Global Quality Systems and Compliance. Essential Functions Responsibilities include but are not limited to: Serve as the strategic leader and operational manager to direct, oversee, and manage all clinical quality assurance activities. Drive the design, analysis, and oversight of global, phase-appropriate clinical Quality Management System (QMS) policies and procedures to ensure compliance to applicable regulations, including U.S. and EU. Direct, oversee, and manage the quality oversight of GCP, GVP and GCLP activities (including SOP/policy development and maintenance, vendor management, internal and external audit functions, and clinical batch release program) to ensure patient safety and data integrity. Provide leadership, direction, and mentorship across all levels of the organization to assure quality assurance strategies are known and implemented. Keep senior leadership apprised of changes to the clinical quality compliance landscape affecting business performance. Develop and administer budgets, plans, and performance requirements linked to the clinical quality assurance department. Hire, develop, and retain clinical QA personnel to create a high-performing credible team. Serve as the primary contact in QA for the oversight of Clinical Studies in US, EU, and ROW to ensure compliance with all GCPs from manufacturing, labeling, distribution, and site qualification to ensure compliance with all regulatory requirements in the country the study is conducted. Liaise with the Head of Clinical, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and Information Technology as needed for the clinical studies. Establish/ensure/remediate as needed the current quality processes, systems and procedures associated with clinical studies. Collaborate with cross-functional management to drive clinical process improvements and alignments. Serve as the primary contact for all regulatory or third-party inspections related to Novavax sponsored clinical and pharmacovigilance activities. This includes on site at Novavax and remote sites. Maintain in depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to GCP and GVP QA activities. Required Knowledge, Skills, and Abilities Knowledge of global regulatory expectations (including FDA and EMA). Experience with senior level interactions and demonstrated collaboration with Clinical, Regulatory, Pharmacovigilance and Medical Affairs functions. Excellent communication and organizational skills. Demonstrated knowledge of GCP, GCLP and GVP regulations for pre-clinical and clinical stage work. Direct experience in successfully managing Health Authority Inspections and multiple projects and responsibilities concurrently. Experienced and fully capable to implement and ensure quality in a GCP-regulated environment (eg, GCP oversight, auditing, electronic systems management, laboratory management, PAI inspection readiness) Skilled in developing collaborative internal and external relationships. Team player willing to roll up her/his sleeves as the situation requires to get the right result; ability to combine hands-on attention to detail with the ability to step back and think strategically. Ability to make rationale, scientific, timely, and compliant risk-based decisions. Excellent verbal and written communication skills Ability to build and manage a high performing group; attract, retain, and coach best talent. Develop direct reports in their career paths, particularly ensuring that a successor is evolved. Ability to think creatively, take a broad systemic view while maintaining a meticulous eye for detail round out the description of the intellectual skills required for this position. Education, Experience, Licenses & Certifications Bachelor's degree in a scientific discipline; Master's degree or higher preferred 15+ years of experience in GMP pharmaceutical, biologics and/or vaccine manufacturing 10+ years of leadership experience in GCP/GVP QA. The annual base salary (or hourly wage) for this position falls within the range of $171,000.00 - $230,850.00. However, the actual base pay offered may vary based on several individualized factors, such as market location, job-related knowledge, skills, and experience. Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.Equal Opportunity Employer/Veterans/Disabled Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.
$171k-230.9k yearly 7d ago
Principal Scientific Business Analyst
Regeneron Pharmaceuticals 4.9
Remote Job
The Principal Business Analyst (BA) in Research and Preclinical Development IT will collaborate with Research Scientists acting as a liaison defining and delivering data management solutions. The BA interfaces between Research Systems Analysts, Programmers, Data Architects, Scientists, and IT Project Managers ensuring information technology designs meet the needs of the end users. In addition, we ensure our solutions meet the requirements by engaging the team in an iterative software development cycle This position will required you to be on-site for 3+ days/week at our Tarrytown, NY offices. We cannot offer a fully remote option. If eligible, we can offer relocation assistance. A typical day may include the following: • Lead scientific-related business needs assessment and design, build and implementation of IT systems. Work with scientists and laboratory personnel understanding business processes and suggesting improvement opportunities. • Define user requirements and design plans solutions into the Research systems architecture through documentation of scientific processes, data workflows, and product/service requirements • Collaborate with end-users and technical teams translating high-level business and user requirements into functional and design specifications. • Act as an expert technical and scientific resource to software development staff in all phases of the development and implementation process • Participate in user research, usability and acceptance testing • Understand system interdependencies and collaborate with project teams accordingly • Assist in evaluating cost-benefit and return on investment analyses • Train, develop and manage junior scientific business analysts • Contributes to the definition, implementation and governance of the BA practices and processes. • May lead or supervise a small team (e.g., 1 - 3 people), assigning day-to-day work. This may be for you if you have: • Strong ability to collaborate with business functional leaders, across all levels in the business supported organization and with technologists. • Experience with critical functional data and management processes, and data integration. • Collaborative, agile approach to drive speedy, creative and efficient use of technology and data to drive business value across IT. • Ability to creatively and constructively challenge designs to ensure simplicity and supportability. • Capable of translating and presenting concepts into practical business terms in both small and large group settings. • Ability to analyze and document complex data management processes. • Ability to think analytically and interpret relevant data and information. To be considered, you must have an Advanced degree (MS or PhD) and 5+ years of scientific experience, including 2+ years in a data, business analyst or relevant IT project execution role. Experience in business process & requirements gathering through is execution. Your Research experience will need to include some of the following: (e.g., biologic and/or small molecule drug discovery, cell biology, molecular biology, immunology, and/or invivo studies). Preferred experiences • Business intelligence tools such as Spotfire, Tableau, Qliksense, Vortex, Power BI. • Project Management of Research programs in a pharmaceutical setting or use of PPM systems to manage projects. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $113,100.00 - $184,700.00
$113.1k-184.7k yearly 43d ago
Quality Assurance Metrics Intern
MacRogenics 4.8
Rockville, MD Job
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.â¯ Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer.â¯Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe. The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization. Summary of Position We are seeking a Quality Right First Time (RFT) Metrics Intern to join our team and assist in developing, tracking, and improving RFT metrics within our manufacturing associated processes. The intern will have the opportunity to create dashboards, assist in the development of key performance indicators (KPIs), and contribute to continuous process improvement initiatives. This role offers a great opportunity to gain hands-on experience in data analysis, quality management, and process optimization in a GMP-compliant environment. Responsibilities and Job Duties Develop and Create Dashboards: Assist in the creation and maintenance of dashboards and visual reports to track Right First Time (RFT) performance and key quality metrics. Assist with KPI Development: Support the development and tracking of Key Performance Indicators (KPIs) related to Right First Time (RFT), including identifying key data points and designing metrics to measure RFT effectiveness. Data Collection and Analysis: Gather data from various manufacturing processes, quality control systems, and other relevant sources. Analyze this data to identify trends, areas for improvement, and potential causes of deviations affecting RFT. Monitor and Report on RFT Trends: Regularly track RFT metrics and report on key findings, highlighting potential issues or areas that require attention. Ensure that data is accurately documented and communicated to stakeholders. Documentation and Compliance: Ensure that all work aligns with GMP standards and company documentation practices. Assist in the preparation of reports, presentations, and training materials related to RFT. Minimum Qualifications Education, Certifications & Experience Currently pursuing a Bachelor's or Master's degree in Life Sciences, Chemistry, Pharmaceutical Sciences, Biotechnology, Engineering, Data Science, or a related field. Completion of coursework in data analysis, quality management, or manufacturing processes is preferred. No prior professional experience is required, though any previous internships, projects, or coursework related to data analysis, quality control, or process improvement is a plus. Exposure to GMP or regulatory standards is beneficial but not mandatory. Knowledge, Skills and Abilities Data Analysis: Familiarity with analyzing data using tools like Microsoft Excel (advanced functions, pivot tables, data visualization) or other data analysis software (e.g., Minitab, Power BI, Tableau) is desirable. Attention to Detail: Strong attention to detail in analyzing data, creating accurate reports, and documenting findings. Communication Skills: Strong written and verbal communication skills to effectively present data, report findings, and collaborate with cross-functional teams. Problem-Solving Skills: Ability to assist in identifying process inefficiencies or areas for improvement related to RFT and suggest actionable solutions. Technical Aptitude: Familiarity with basic manufacturing processes, quality control systems, or dashboards/reporting tools is a plus but not required. Collaboration: Ability to work in a team environment and communicate effectively with individuals from different departments, such as manufacturing, quality assurance, and process improvement. Additional Information The hourly rate of pay for this position is $21.50. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. Eligible intern employees may participate in the 401(k) plan with employer match and may receive the company holiday benefit if the holiday falls on a regularly scheduled workday. An intern will accrue one hour of sick leave for every 30 hours of working time. Interns are responsible for their own travel, housing, and living expenses. The pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. Statement MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email ******************** or call ************** and/or 711 for TTD/TTY service. Equal Opportunity Employer/Veterans/Disabled We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.
$21.5 hourly 18d ago
Sr. Director, Corporate Development - Scientific and Technical Assessments (Remote) (36281)
Emergent Biosolutions 4.8
Remote or Gaithersburg, MD Job
We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life. I. JOB SUMMARY The Senior Director, Scientific & Technical Assessments will lead all aspects of technical due diligence, evaluate and assess new M&A-related opportunities and provide updates to the VP Corporate Development, key internal stakeholders and the Executive Management Team. The candidate should have a strong technical background, experience working in and/or leading product development programs within the biotech/pharmaceutical industry and a deep understanding of the drug discovery product development cycle for new therapies (e.g. vaccines, biologics, small molecules, etc.). II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Lead and manage technical due diligence activities associated with business development transitions and other corporate business development activities including data-room management and collaboration with functional area subject matter experts (preclinical, non-clinical, manufacturing, clinical, quality and regulatory) and external consultants Conduct scientific and data driven analyses and prepare written, oral summaries and reports of the uncovered opportunities or risks related to new product/company opportunities Develop and implement new and innovative approaches to assess new product candidates and technologies in support of enterprise and business strategies In conjunction with BD&L leads complete search and evaluation projects of development opportunities in markets of interest to identify strategically attractive inorganic development opportunities Remain up to date on cutting edge technology developments by engaging with external key opinion leaders and/or subject matter experts, internal stakeholders, and continuous exploration of published literature Lead and coordinate presentation of scientific data and technical assessment to Executive Management Team and the Emergent Board of Directors Provide input to Corporate Development's valuation/financial model assumptions for new opportunities Provide technical input for generation of target product profile to be used in market landscape analysis and commercial assessments for the business development team Communicate with IP/Legal to assist with intellectual property patent due diligence for new technologies and therapeutics Provide technical insights for definitive agreement warranties and representations for legal contracts supporting business development opportunities Assist updates to enterprise/business strategy with evaluation of new and disruptive innovation opportunities and academic collaborations Provide technical due diligence training to subject matter experts representing functional areas in support of due diligence on business development opportunities Attend scientific and business conferences relevant to Corporate Development and enterprise strategic focus areas Retain and manage external scientific resources in support of the foregoing The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS Advanced degree (e.g. MS/PhD/PharmD/MD) in life-sciences such as; biochemistry, biology, molecular biology, immunology, chemistry with an emphasis on public health threats and infectious diseases, utilizing vaccine and mAB technology platforms Solid scientific training and experience in the biotech/pharmaceutical industry MBA or other relevant advanced business experience (e.g. PhD/MBA, MBA w/drug discovery experience) Ability to work well with colleagues across multiple functions including Research, Clinical, Regulatory, Manufacturing, Quality, Finance, Legal, Program Management and others Experience with project management and leading cross-functional teams Experience in successfully leading and executing scientific and technical dur diligence in an efficient and effective manner Strong presentation and communication skills, with experience in presenting scientific and technical recommendations to executive management and board Background in operational efficiency or lean six sigma methodology would be considered a plus IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job. The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical/Mental Demands and Work Environment Characteristics: Mental Demands: ☒ Ability to organize/coordinate ☒ Comprehend and follow instructions ☒ Direct, control and plan ☒ Independently make quick decisions to solve complex issues ☒ Problem Solve ☒ Analyze/Interpret data and information ☒ Perform with frequent interruptions ☒ Make decisions using sound judgment ☒ Supervise/Manage others Physical Demands: ☒ Use keyboard/computer/phone ☒ Detect/Distinguish hearing ☒ Maintain stationary position ☒ Position self to move ☒ Reaching ☒ Move/Transport 2 lb. ☒ Repetitive movement activities Environmental Characteristics: ☒ Regular and predictable attendance Travel: Approximately 10% #remote U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from [$192,500 to $233,000]. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: ************************************************************* (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
$192.5k-233k yearly 26d ago
E-Learning Training Intern
MacRogenics 4.8
Rockville, MD Job
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.â¯ Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer.â¯Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe. The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization. Summary of Position We are seeking an enthusiastic and motivated intern to join our Quality Assurance (QA) team and assist in the development of computer-based training (CBT) modules for Good Manufacturing Practices (GMP), with a focus on deviation investigations and root cause analysis. This is a unique opportunity for an intern to gain hands-on experience in e-learning development, instructional design, and compliance training in a highly regulated industry. As an Instructional Design/E-Learning Development Intern, you will work closely with subject matter experts (SMEs) to create engaging, interactive, and effective training materials that ensure employees are equipped with the knowledge to handle deviations and perform root cause analysis within GMP guidelines. Responsibilities and Job Duties Assist in Designing and Developing E-Learning Courses by collaborating with SMEs to develop CBT modules focused on deviation investigations and root cause analysis in GMP environments. This may include storyboarding and outlining course content, creating interactive scenarios, quizzes, and knowledge checks, designing graphics, infographics, and multimedia elements (e.g., videos, animations). Work closely with GMP compliance experts and quality assurance teams to ensure technical accuracy in training content related to deviation management and root cause analysis. Assist in applying the Kirkpatrick Training Evaluation Model to gather feedback from learners and stakeholders, evaluate the effectiveness of the training across all four levels (Reaction, Learning, Behavior, Results), and recommend improvements based on the findings. Utilize E-Learning Authoring Tools (e.g., Articulate Storyline, Adobe Captivate, Lectora) to create visually appealing, interactive, and user-friendly online courses. Assist in Content Development by creating clear, concise, and engaging content for training modules, ensuring alignment with GMP guidelines, deviation investigation procedures, and root cause analysis methods. Test and Review Training Modules to ensure they function properly across various devices Assist in uploading completed training materials to the Learning Management System (LMS) (e.g., MasterControl), ensuring proper tracking and reporting functionality for learner progress. Minimum Qualifications Education, Certifications & Experience Currently enrolled in or recently graduated from a degree program in Instructional Design, Educational Technology, Life Sciences (Biology, Chemistry, Biotechnology), Pharmaceutical Sciences, or a related field. No professional experience required, though any academic projects or internships related to instructional design, e-learning, or pharmaceutical training are a plus. Knowledge, Skills and Abilities Familiarity with instructional design principles (ADDIE model or similar frameworks) and course development. Experience with e-learning development tools (e.g., Articulate Storyline, Adobe Captivate) is a plus. Proficiency with graphic design software (e.g., Adobe Photoshop, Canva) and video editing tools (e.g., Camtasia, Audacity) for creating and editing multimedia content. Strong communication skills to work with subject matter experts and stakeholders, and to convey complex concepts clearly in training materials. Ability to work independently and collaboratively in a team environment, with attention to detail and strong time management skills. Proficient in Microsoft Office Suite (especially PowerPoint and Excel) for content development, planning, and project tracking. Creative problem-solving skills to develop engaging, interactive, and effective training content. Preferred Qualifications Familiarity with SCORM and AICC standards for e-learning. Basic knowledge of HTML/CSS or JavaScript for custom e-learning content. Prior experience in instructional design, adult learning principles, or developing e-learning content is a plus. Additional Information The hourly rate of pay for this position is $21.50. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. Eligible intern employees may participate in the 401(k) plan with employer match and may receive the company holiday benefit if the holiday falls on a regularly scheduled workday. An intern will accrue one hour of sick leave for every 30 hours of working time. Interns are responsible for their own travel, housing, and living expenses. The pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. Statement MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email ******************** or call ************** and/or 711 for TTD/TTY service. Equal Opportunity Employer/Veterans/Disabled We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.
$21.5 hourly 18d ago
Scientist I/II
MacRogenics 4.8
Rockville, MD Job
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.â¯ Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer.â¯Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe. The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization. Summary of Position This position is part of the Protein Science group within the Research department. The Scientist I/II will be responsible for the analysis of biomolecular interactions using Surface Plasmon Resonance (SPR) and Biolayer Interferometry (BLI) to analyze biomolecular interactions, primarily focusing on antibody-antigen binding kinetics in support of the biologics research pipeline. Additional roles include the purification of recombinant proteins and their characterization by HPLC and capillary electrophoresis. Responsibilities and Job Duties Design, execute, and analyze SPR and BLI experiments to determine antibody affinities, kinetics, and epitopes. Maintain SPR and BLI instruments Purify proteins and perform routine analytical characterization Confirm protein identity by Liquid Chromatography-Mass Spectrometry (LC-MS) Conduct protein stability tests for lead molecule selection Maintain timely and accurate records Minimum Qualifications Scientist I Education & Other Credentials Bachelor's (BS/BA) in Biochemistry or a related scientific field of study with 3+ years of bench-related experience within industry and/or academia. OR A Master's degree in Biochemistry or a related scientific field of study with 0 years of bench-related experience within industry and/or academia. Scientist II Education & Other Credentials Bachelor's (BS/BA) in Biochemistry or a related scientific field of study with 5+ years of strong bench-related experience within industry and/or academia. OR A Master's degree in Biochemistry or a related scientific field of study with 2+ years of strong bench-related experience within industry and/or academia. Knowledge, Skills and Abilities Understanding of biophysical principles governing protein-protein interactions and binding kinetics Hands-on experience with SPR and BLI instruments Ability to handle multiple tasks and willing to collaborate with other teams Excellent written and verbal communications skills Maintain timely and accurate records Supervisory Responsibilities: No. Preferred Knowledge and Skills Knowledge and experience about protein purification Hand-on experience with AKTA chromatography system preferred Hand-on experience with HPLC or LC-MS preferred Additional Information The annual rate of pay for this position ranges from $84,400 - $128,800 (Scientist I) and $94,300 - $143,800 (Scientist II). For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits. The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. Statement MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email ******************** or call ************** and/or 711 for TTD/TTY service. Equal Opportunity Employer/Veterans/Disabled We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.
$94.3k-143.8k yearly 18d ago
Lead Digital/Robotics & Enabling Tech
Johnson & Johnson 4.7
Remote or Raritan, NJ Job
* Job title Lead Digital/Robotics & Enabling Tech * Function Supply Chain Deliver * Sub function Warehouse & Distribution * Category Senior Analyst, Warehouse & Distribution (P6) * Date posted Mar 28 2025 * Requisition number R-005522 * Work pattern Fully Remote This job posting is anticipated to close on Apr 04 2025. We may however extend this time period, in which case the posting will remain available on ******************* to accept additional applications. Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Supply Chain Deliver Job Sub Function: Warehouse & Distribution Job Category: Professional All Job Posting Locations: Palm Beach Gardens, Florida, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America Job Description: Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech We are searching for the best talent for a Lead Digital/Robotics & Enabling Tech to be in Raritan, NJ! We are open to candidates based in Raynham, MA, Palm Beach Gardens, FL, or West Chester, PA! Remote options maybe considered for US based candidates on a case by case basis if approved by the company. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that's reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech Are you interested in making a difference in a thriving diverse company culture, that celebrates the uniqueness of our employees and is committed to inclusion Apply today! Key Responsibilities: * Help connect and integrate US Deliver, NPIs, and Marketing/Commercial Strategies into successful and sustainable E2E Digital/Robotics operating models. This will include - Go to Market strategy execution, operations capability building, and crisis management. * Represent and ensure the integration of Digital/Robotics insights into regional strategic and business planning as well as key business projects. * Support the execution of Digital/Robotics cost, operational efficiency, and risk mitigation improvement projects while partnering with E2E cross-functional partners, ensuring Supply Chain, Finance, and Commercial alignment and engagement. * Leads and directs Digital/Robotics New Product Introductions/Launches, working cross functionally to establish sustainable and scalable E2E processes and capabilities to support the specific needs of the digital/robotics portfolio. * Provide inputs from Deliver stakeholders and cross-functional partners to ensure maintenance of the Deliver Digital/Robotics project tracker. Host a forum with Deliver stakeholders and leadership to communicate and track project milestones, risks/issues, and ensure project alignment with organizational goals. * Accountable for NA Regional digital robotics operations performance metrics for the Deliver organization. Share regional Deliver performance insights in leadership broader forums. Qualifications Education: * Bachelor's degree required; master's degree preferred Experience and Skills: Required: * Minimum 4 years of business experience is required, with at least 3 years of experience across Supply Chain, Operations or Commercial. * Knowledge of E2E Supply Chain processes is required. * Experience delivering results against performance targets and strict timeline deliverables is required. * Ability to promote a vision, drive change, and transform teams (direct and matrixed) in alignment with evolving business objectives, via strong engagement and communication, is required. * Ability to build strong partnerships and influence internally & externally, with customer focus, is required. * Experience and success in managing complex projects & delivering business results is required. Preferred: * Experience in USROTC (SAP) processes and procedures preferred * Demonstrated impact in increasingly complex leadership roles, including roles requiring orchestration, stakeholder management, delivery of results and influence at varying organizational levels. Experience supporting operations and / or previous experience engaged in digital/robotics and services supply chains is preferred * Prior experience working in partnership with Commercial Operations is preferred. * Prior experience with Digital/Robotics logistics capability needs is preferred. * Operational leadership, specifically within Distribution or Logistics, is preferred. * Certification in Lean, Six Sigma or Process Excellence (preferred) Project management experience and certification such as FPX (preferred) Other: * English Fluency * Travel required 10-15% of the time * The anticipated base pay range for this position is $91,000.00 - 165,000.00 USD Annual * The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. * Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. * For additional general information on company benefits, please go to: ********************************************* * This job posting is anticipated to close on [Month/Day/Year]. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. * . Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit *******************.] The anticipated base pay range for this position is : Additional Description for Pay Transparency:
$91k-165k yearly 4d ago
Sr Field Clinical Specialist - Shockwave-Reducer - Remote
J&J Family of Companies 4.7
Remote or New Brighton, MN Job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** R&D Operations **Job Sub** **Function:** Clinical/Medical Operations **Job Category:** Professional **All Job Posting Locations:** New Brighton, Minnesota, United States of America **Job Description:** At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. **Position Overview** The Sr. Field Clinical Specialist/ Engineer will provide case support on Shockwave Medical products including Reducer and intravascular lithotripsy (IVL). The Sr. Field Clinical Engineer will play a critical role in clinical studies including device training, case support, and ensuring timely data collection for clinical programs. This work is accomplished with oversight, requires contact with internal stakeholders, frequent travel to clinical trial sites, works closely with physician advisors, and is critical to business success. **Must be able to travel approximately 80% mostly in the US and Canada, and potentially outside North America and will require** **close proximity to a major airport hub for travel efficiency. Must have a passport or able to get a passport.** **Essential Job Functions** + Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices. + Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, including study protocol, instructions for use, core lab manuals and case report forms. + Provide clinical and technical support for key study investigators and clinical leaders at assigned sites. + Partner with other clinical research colleagues to meet business needs in the field including study start-up, site training, data collection for timely database locks and resolution of critical issues. + Administrative activities include training to procedures at site level. + Collaborate effectively with internal stakeholders (Clinical Affairs, Medical Affairs, Marketing and Medical Education) and external parties (vendors and physician advisors) to ensure Shockwave Medical clinical trials meet established enrollment goals. + Collaborate with internal and external stakeholders to develop a repository of recruitment/study awareness materials and tools. + Collaborate with internal and external stakeholders to ensure site-specific recruitment plans are implemented and progress tracked. + Develop and maintain strong relationships with site investigators and research staff to understand site recruitment and enrollment processes and resolve obstacles to enrollment to meet study goals. + Partner with assigned physician advisors to create and deliver recruitment strategies. + Partner with vendors that support recruitment activities. + Other duties as assigned. **Requirements** + Bachelor's Degree in a scientific field of study or equivalent work experience. + Minimum of 5 years of relevant experience with at least 3 years of experience directly supporting interventional or surgical procedures within a hospital. + **Must be able to travel approximately 80% mostly in the US and Canada, and potentially outside North America.** + Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running investigational device exemption (IDE) trials. + Thorough knowledge of Good Clinical Practice (GCP) is required. + Ability to attain and maintain hospital credentials. + Ability to work in a fast-paced environment while managing multiple priorities. + Operate as a team and/or independently while demonstrating flexibility to changing requirements. + Experience with electronic data capture (EDC) systems. + Must have excellent verbal and written communication skills. + High attention to detail and accuracy. + Able to manage multiple project teams with guidance + Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.) The anticipated salary range for this position is 89,000.00 - 161,000.00 The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. + Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). + This position is eligible to participate in the Company's long-term incentive program. + Employees are eligible for the following time off benefits: + Vacation - up to 120 hours per calendar year + Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year + Holiday pay, including Floating Holidays - up to 13 days per calendar year + Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. ********************************************* _Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability._ _For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit_ _******************** _._ **The anticipated base pay range for this position is :** 89,000.00 - 161,000.00 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
$99k-129k yearly est. 19d ago
Biostatistics Associate Director (HYBRID)
Vertex Pharmaceuticals 4.6
Remote or Boston, MA Job
The Biostatistics Associate Director will perform sophisticated scientific statistical analyses in support of the company's Global Medicines Development and Affairs area with minimal guidance and mentoring on new and complex issues. The incumbent should be capable of independent strategic and technical contributions and possess a good knowledge of related disciplines while performing Biostatistics activities with a drug developer mindset. This is a hybrid position which allows 2days per week remote work and 3 days per week in the Boston Seaport office. (Relocation Assistance is available). Key Duties and Responsibilities: Conducts all scientific and operational statistical work for multiple clinical trials, observational studies, or real world data (RWD) investigations. Leads biostatistics projects or major components of a project including work allocation and review. May include presentation to the Peer Protocol Review Committee (PPRC) or other internal senior review boards. Possesses an advanced and in-depth understanding of modern drug discovery and development processes. Represents Biostatistics as a member of cross functional teams, providing input and specialized technical guidance to elicit meaningful and/or productive outcomes. Authors study Statistical Analysis Plans (SAPs), including table, figure, and listing (TFL) shells. Develops Cross-functional Data Review (xFDR) plan, Key Reports Memo (KRM), and Data Dissemination Plan (DDP) in order to facilitate the review, summary, and dissemination of key study data/results. Collaborates with statistical programming and other functions to ensure timely delivery of TFLs with high quality. Contributes to clinical study reports (CSRs) and related processes, authoring or co-authoring methodological or study-related publications and posters. Provides input into programming specifications and review. Contributes to external interactions with regulators, payers, review boards, etc. Authors or co-authors methodological or study-related publications and posters. Determines and implements design and analysis methods at the study or project level and participates in Statistical Review Forum (SRF) discussions of studies assigned to others. Contributes to departmental working group efforts on various advanced technical and operational issues. Independently undertakes new and complex issues. Completes assigned work in a resourceful, self-sufficient manner, often conceptualizing alternative approaches to achieve desired results. Develops breadth of knowledge across related disciplines with a drug developer mindset. Knowledge and Skills: Some prior staff management experience is typical In-depth competence with SAS and R statistical software In-depth understanding of advanced statistical methods used in drug development Ability to show critical thinking with logical problem-solving Excellent written and verbal communication skills Excels in a team environment Collaborates well with non-statisticians NDA/MAA experience and direct dealings with USA/European regulators Education and Experience: Ph. D. in Statistics or Biostatistics. Typically requires 7 years of experience with a Ph.D. #LI-AR1 #LI-Hybrid Pay Range: $164,800 - $247,200 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
$164.8k-247.2k yearly 3d ago
Associate Director, Field Medical Affairs-Hematology (southern CA/Hawaii)
Regeneron Pharmaceuticals 4.9
Remote Job
As an Associate Director, Field Medical Affairs (Medical Science Liaison) you will engage in the exchange of our scientific data and medical information with KOLs, HCPs, researchers, pharmacists and population-based decision makers. We are expected to demonstrate a thorough understanding of B-Cell Malignancies (NHL and Multiple Myeloma) aligned with our strategic medical plans. **A typical day may include the following:** + Identifying and maintaining a list of medical/therapeutic area experts, investigator targets and associated plans of action. + Establishing, fostering, cultivating and maintaining relationships with KOLs in Hematological Malignancies + Act as the primary clinical/scientific resource for information pertaining to disease state and our products ensuring awareness and understanding. + Participates in the development and management of company sponsored clinical trials including. + Establishing scientific relationship with investigators and internal Medical Affairs, supporting investigator-initiated study (IIS) concept program. + Identifying relevant insights on research developments, treatment landscape to shape medical strategy + Identifies gaps in research needs and creates opportunities by collaborating with potential and existing investigators and site personnel. + Responds to requests for information related to study indications, disease state and therapeutic area, and presents/discusses scientific/clinical data. + Attends medical conferences collecting and reporting relevant, scientific, clinical, & competitive intelligence. + Ensures company policies, procedures, principles and financial controls are maintained with integrity and professionalism is displayed internally and externally **This may be for you if you:** + Want to be a part of a pre-launch stage team potentially for multiple launches. + Are skilled in the art of strategic conversation along with a proven ability to assess issues adapting appropriately. + Can demonstrate an understanding of "know your audience" and ability to tailor information appropriately. + Have demonstrated the ability to anticipate, organize, plan and handle multiple priorities, while adapting to the needs of the company. To be considered a terminal scientific degree (MD, PharmD, or PhD) is required. 8+ years of experience with a minimum of 4 years experience within a Hematology/Oncology Medical Science Liaison function is required. Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines. Additional requirements: - Residency in the assigned territory - Travel: Capable of engaging in frequent business travel (approximately 70% of time), including air travel, overnight and occasionally on weekends. - Possesses and maintains a valid driver's license and clean driving record. Preferred experiences include: - Established relationships with KOLs and institutions focused on Hematologic Malignancies - Drug launch experience. \#msl #medicalscienceliaison #hematology Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. **Salary Range (annually)** $173,500.00 - $283,100.00
$173.5k-283.1k yearly 60d+ ago
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
J&J Family of Companies 4.7
Remote or New Brighton, MN Job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job Category:** Professional **All Job Posting Locations:** Baltimore, Maryland, United States, Chicago, Illinois, United States, Irvine, California, United States of America, Philadelphia, Pennsylvania, United States, Portland, Oregon, United States, Raleigh, North Carolina, United States, San Diego, California, United States of America, San Francisco, California, United States of America, San Jose, California, United States of America, Santa Clara, California, United States of America, Seattle, Washington, United States of America, South San Francisco, California, United States of America, US360 MN New Brighton - 600 County Road D W **Job Description:** Johnson & Johnson is hiring for a **Sr Regulatory Affairs Specialist (Ad/Promo) - Shockwave Medical** to join our team located in **New Brighton, MN or Remote US** . At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/ . Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. **Position Overview** The Senior Regulatory Affairs Specialist overseeing advertising and promotional Regulatory responsibilities, works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Senior Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that advertising and promotion activities meet geography specific regulatory requirements. In alignment with responsible Regulatory Affairs Management, the Senior Regulatory Affairs Specialist, (Advertising/Promotion) is responsible for reviewing, editing and supporting compliance of SWMI advertising and promotional material and internal procedures/training. This individual supports decision-making for advertising and promotion regulatory activities. **Essential Job Functions** + Collaboratively interface with marketing/sales personnel and other cross-functional departments and external entities, as applicable to review and provide guidance on advertising/promotion materials and messaging in compliance with SWMI commercial approvals and within established timelines. + Maintain geography specific advertising and promotion regulatory policies, processes and SOPs and train key internal stakeholders. + In collaboration with marketing personnel, assist RA leadership in establishing and maintaining product claims matrices for worldwide reference. + Conduct Regulatory advertising and promotional material reviews to ensure promotional, scientific, medical, and corporate external communications are compliant with applicable regulations, guidelines, corporate polices and business objectives. Approve advertising and promotional materials to ensure compliance. + Ensure that changes in product labeling are appropriately reflected in current promotions and advertising. + Work collaboratively with the commercial team and any associated compliance functions to ensure that approved materials are used within the intended guidelines and duration of use. + Identify potential areas of regulatory compliance vulnerability and risk or opportunities for improvement; and develop/implement corrective action plans for resolution of problematic issues with guidance from RA leadership. + Identify and communicate emerging issues to RA leadership. + Plan and conduct meetings, create project plans and timelines, and manage projects with guidance from RA leadership, when assigned. + Exercise good and ethical judgment within policy and regulations. + Other duties as assigned. **Qualifications** + Minimum 5 years' experience in a regulated healthcare industry with Bachelor's degree; or 3 years and a Master's degree; or a PhD without experience; or equivalent experience. Degree in science, math, engineering, medical or other technical fields and Class III medical device experience are preferred. + Minimum 1-2 years of experience completing regulatory affairs reviews of advertising and promotional related material in a medical device environment. Pharmaceutical experience may be considered. + Advanced knowledge of FDA guidelines and regulations with an emphasis on product promotional activities. Worldwide knowledge of advertising and promotional guidelines and regulations is a plus. + Develop and/or maintain advertising/promotion documents such as a core claims document and related SOPs. + Ability to work accurately and collaboratively in a fast-paced environment while managing multiple priorities. + Apply effective communication skills, with the ability to convey messages in a logical and concise manner. + Ability to consistently reinforce regulatory expectations and requirements. + Think analytically with good problem solving skills. + Effectively negotiate internally and externally with regulatory agencies. + Clear and effective verbal and written communication skills with diverse audiences and personnel. + Support and comply with the company's Quality Management System policies and procedures. + Ability to act with an inclusion mindset and model these behaviors for the organization. + Knowledge of business functions and cross group dependencies/ relationships. + Ability to follow scientific arguments and identify regulatory scientific data needs. + Operate as a team and/or independently while demonstrating flexibility to changing requirements. + Must be able to travel as needed, approximately 1-2 times a year. + Proficiency in MS Word, Excel and PowerPoint required. **Additional Information:** The anticipated salary range for this position is: Outside of Bay Area: $89,000- $143,750 Bay Area, California: $103,000-$165,600 The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. + Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. + Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). + This position is eligible to participate in the Company's long-term incentive program. + Employees are eligible for the following time off benefits: + Vacation - up to 120 hours per calendar year + Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year + Holiday pay, including Floating Holidays - up to 13 days per calendar year + Work, Personal and Family Time - up to 40 hours per calendar year + Additional information can be found through the link below. ********************************************* The compensation and benefits information set forth in this posting applies to candidates hired in the United States. _· Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability._ _For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit ********************* **The anticipated base pay range for this position is :** "Rest of US: $89,000- $143,750 BA: $103,000-$165,600" Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
$103k-165.6k yearly 27d ago
Principal Clinical Safety Specialist - Shockwave Reducer
Johnson & Johnson 4.7
Remote or Santa Clara, CA Job
* Job title Principal Clinical Safety Specialist - Shockwave Reducer * Function Product Safety * Sub function Drug & Product Safety Operations * Category Senior Analyst, Drug & Product Safety Operations (P6) * Date posted Mar 24 2025 * Requisition number R-004188 * Work pattern Fully Remote This job posting is anticipated to close on Apr 01 2025. We may however extend this time period, in which case the posting will remain available on ******************* to accept additional applications. Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Product Safety Job Sub Function: Drug & Product Safety Operations Job Category: Professional All Job Posting Locations: New Brighton, Minnesota, United States of America, Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Principal Clinical Safety Specialist- Shockwave Reducer to join our team located in New Brighton, MN. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Principal Clinical Safety Specialist will have primary responsibility for study or program oversight, ensuring all aspects of safety are conducted according to procedure and in a compliant manner. The Principal Clinical Safety Specialist may oversee one or more studies, assuming ownership for study-specific requirements. This may include special projects, process development, vendor oversight, audit participation, and providing advisory to the clinical and post-market surveillance teams. In addition, the Principal Clinical Safety Specialist will be responsible for providing backup support for adverse event collection and processing, safety monitoring, maintenance of study-specific Safety Management Plans, and participation in writing and/or reviewing safety sections of clinical study documents. This may also include management of Clinical Events Committee(s) and Data Safety Monitoring Board(s). Essential Job Functions * Assumes wholistic responsibility for safety management and monitoring for one or more clinical studies, including: * Establishment of end-to-end safety documentation system; development of study-specific plans, procedures and data entry guidelines * Compliance with pre-market regulatory reporting of Serious Adverse Events (SAEs) and Device Deficiencies (DDs) * Assurance of high-quality safety data collection * Provision of direction and guidance to safety vendor(s), escalating vendor management issues as appropriate * Management of Clinical Events Committees (CEC) and Data and Safety Monitoring Boards (DSMB) * Serving as liaison and advisor to the post-market surveillance team to resolve complaints-related issues * Use of appropriate medical and regulatory judgement in escalating any safety concerns * In addition, the Principal Clinical Safety Specialist may provide support for any of the following: * Review, evaluation of, and tracking of incoming adverse events (AEs) including follow-up of ongoing events * Collaboration with sites/monitors/Contract Research Organization (CRO) to ensure comprehensive information is available for full review of adverse events * Drafting or review of SAE narratives * Distribution and notification of AEs to appropriate teams and clinical sites, as needed * Liaison for safety-related questions from Clinical Affairs, CRO, monitors, Field Clinical Specialists, post-market quality, surveillance, etc. * Verification of consistency and compliance in application of protocol definitions for adjudication outcomes * Providing input to the development and management of study related documents including clinical protocols, case report forms, monitoring plans, study manuals, and other study tools related to adverse event reporting and definitions * Assistance with preparation of safety reporting for annual reports, clinical study reports, investigator brochure updates, and other documents as required * Maintains knowledge of current FDA, ISO, competent authority, IRB, REB, and EC regulatory rules and policies affecting AE reporting * Assists in training of study personnel regarding the adverse event definitions per protocol * Collaborates on additional Clinical Affair's activities, as required * Other duties as assigned Requirements * RN or equivalent healthcare experience, with Bachelor's degree preferred * Minimum 10+ years' experience in clinical safety or combined clinical safety/post-market vigilance experience, with prior clinical research experience preferred * Experience in cardiovascular disease preferred * Experience with medical device clinical studies preferred * Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology * Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.) * Good prioritization and organizational skills * High attention to detail and degree of accuracy * Familiarity with electronic data capture (EDC) systems * Operates both as a team and independently, with adaptability to changing requirements * Experience coordinating, prioritizing, setting timelines, and multi-tasking. * Expertise with medical device regulations and compliance guidelines for clinical studies including ISO 14155, 21 CFR 812, EU MDR, and other relevant guidance documents * Position requires approximately 10% travel Pay Transparency: * The anticipated salary range for this position is $121,000 - $194,350 * The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. * Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. * Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). * This position is eligible to participate in the Company's long-term incentive program. * Employees are eligible for the following time off benefits: * Vacation - up to 120 hours per calendar year * Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year * Holiday pay, including Floating Holidays - up to 13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year * Additional information can be found through the link below. ********************************************* Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource.
$66k-85k yearly est. 8d ago
Intellectual Property Manager (Remote) (36288)
Emergent Biosolutions 4.8
Remote or Gaithersburg, MD Job
We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life. I. JOB SUMMARY The Intellectual Property Manager will support our Intellectual Property Legal team by providing services related to trademarks, patents, invention disclosures, trademark registration renewals, and annuity payments. This role will provide oversight for the development of Emergent BioSolutions Inc.'s (Emergent) intellectual property (IP) portfolio, with a strong emphasis on managing trademarks. This role is responsible for supporting the implementation of strategies to protect and leverage Emergent's IP assets, maintaining compliance with applicable IP laws, and mitigating risks associated with IP rights. The Intellectual Property Manager will report to the Associate General Counsel, Head of IP and work closely with cross-functional teams, including R&D, legal, and marketing, to ensure alignment between Emergent's business goals and its IP strategy. II. ESSENTIAL FUNCTIONS Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. IP Portfolio Management Oversee and manage Emergent's IP portfolio, including patents, trademarks, copyrights, and trade secrets: Maintain internal docket system and oversee all incoming correspondence with action due dates; prepare assignments, declarations, Information Disclosure Statements, Statements of Use, Extensions of Time, and other documents necessary to support prosecution activity; secure internal signatures; integrate new assets into and dispose of authorized assets from the docketing system; communicate with outside counsel; manage internal renewal and annuity systems for auto-pay activities. Develop and implement strategies to maximize the value of the company's IP assets, including monitoring renewals, maintaining records, and enforcing rights. Track new developments in IP law, updating internal practices as necessary. Support for intellectual property group budgeting and forecasting, including tracking and maintenance of outside counsel invoices. Collaborate with Emergent leadership to establish short- and long-term IP goals and strategies that align with overall company objectives. Trademark Management Manage the lifecycle of all company trademarks, including filing, renewal, enforcement, and monitoring for potential infringements. Liaise with internal clients on new and existing trademark, logo, and slogan assets; conduct trademark clearance searches to evaluate potential new marks, and work with legal counsel to file applications in domestic and international jurisdictions. Oversee third-party use of Emergent's trademarks, ensuring brand protection through enforcement and management of trademark licenses and co-branding agreements. Patent Management Oversee and assist with all domestic and foreign patent filing processes and procedures, including best practices, checklists, related documents, research, analysis, and e-filings. Assist with updating the USPTO account for Emergent's IP Legal team. Work with R&D and legal to identify, document, and protect valuable innovations. Assists R&D with the assessment of and improvements of patent prosecution processes and procedures, workflow, training, and compliance. Maintain/archive all invention disclosures received and monitor the review process for filing new patent applications. Cross-Functional Collaboration & Training Collaborate with the marketing and product teams to ensure brand assets are used consistently and in line with company policy. Maintain an internal list of proper trademark usage. Perform risk assessments on IP-related projects and provide guidance on IP issues in M&A, licensing, and other commercial transactions. Provide training and support to employees on IP policies and procedures, helping to foster a culture of IP awareness and compliance. IP Dispute Resolution & Enforcement Support IP disputes, including preparing responses to potential IP infringements and overseeing enforcement actions when necessary. Collaborate with marketing and product teams on brand protection matters. Engage with external IP counsel and enforcement agencies as needed. The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions. III. MINIMUM EDUCATION, EXPERIENCE, SKILLS Bachelor's degree required. Minimum of 8-10 years of experience in trademark and patent prosecution as a paralegal, technology specialist, or comparable position in a law firm or in-house legal department. Experience managing IP portfolios, including patents, trademarks, copyrights, and trade secrets, and working with IP management software and databases. Expertise in domestic and foreign IP laws, regulations, and U.S. Patent and Trademark office (USPTO) procedures, rules, and requirements. Maintain high standard by exhibiting excellent organizational skills and attention to detail. Ability to effectively manage multiple projects and responsibilities High level of initiative, effort, and commitment towards driving results for department and team. Ability to identify, analyze, and resolve issues while exhibiting good reason and judgement. Exceptional interpersonal and communication skills (oral and written), professional demeanor, and team building skills. Ability to work collaboratively with cross-functional teams and participate in IP strategy discussions with senior stakeholders. Proven ability to recognize confidential, sensitive, and proprietary information and maintain such information as confidential. Self-motivated and capable of working both independently and as part of a team. High level of computer proficiency in Windows-based software and Microsoft Office Suite applications, Adobe Acrobat, U.S. Patent Office Electronic Filing System, and other internet research tools. IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job. The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical/Mental Demands and Work Environment Characteristics: Mental Demands: ☒ Ability to organize/coordinate ☒ Comprehend and follow instructions ☒ Problem Solve ☒ Analyze/Interpret data and information ☒ Make decisions using sound judgment Physical Demands: ☒ Visual Acuity ☒ Use keyboard/computer/phone Environmental Characteristics: ☒ Regular and predictable attendance Travel: Minimal travel maybe required #remote U.S. Base Pay Ranges and Benefits Information The estimated annual base salary as a new hire for this position ranges from [$117,500 to $142,100]. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.] Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: ************************************************************* (*Eligibility for benefits is governed by the applicable plan documents and policies). If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits. There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions. Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our . Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
$37k-49k yearly est. 10d ago
Clinical Data Scientist Co-Op
Johnson & Johnson 4.7
Remote or Irvine, CA Job
* Job title Clinical Data Scientist Co-Op * Function Career Programs * Sub function Non-LDP Intern/Co-Op * Category Intern/Co-Op, Non-LDP Intern/Co-Op (C) * Date posted Mar 25 2025 * Requisition number R-005224 * Work pattern Hybrid Work This job posting is anticipated to close on Mar 25 2025. We may however extend this time period, in which case the posting will remain available on ******************* to accept additional applications. Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Career Programs Job Sub Function: Non-LDP Intern/Co-Op Job Category: Career Program All Job Posting Locations: Irvine, California, United States of America Job Description: At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/. About Cardiovascular: Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech We are searching for the best talent for Clinical Data Scientist Co-Op to be in Irvine, CA. Purpose: We are revolutionizing healthcare by leveraging technology, data, and the power of teamwork to overcome the world's most significant healthcare challenges. We are looking for passionate and driven Biostatistics, Programming, and Data Management (BPDM) interns to join our J&J MedTech - Cardiovascular & Specialty Solution Group (CSS) team for a paid summer internship program. Remote work may be necessary in compliance with public health regulations and will be accommodated. * The Co-op term is from May to November 2025 * Required to work full-time or 20 hours per week during that time. You will be responsible for: As a J&J MedTech BPDM intern, you will have the opportunity to work with practicing statisticians and data engineers to learn about statistical and data science applications specific to clinical or nonclinical settings in medical devices. You will support projects in areas that range from clinical studies, post marketing studies, Real World Evidence registry studies, and concurrently, participate in working groups such as the Statistical Methodology/Consulting Working Group, Machine Learning Working Group, RWE/Publication Support Team, and R, Python, SAS User Groups. BPDM interns will be involved in various activities, including data preparation, graphical exploration of data, statistical model building and analysis, report writing, and writing of computer programs or software applications associated with the participated projects. Other activities may include designing experiments, conducting simulations to evaluate optimal designs, and participation in methodological development. Qualifications / Requirements: * Candidates are currently pursuing a Bachelor, Master, or PhD degree in Biostatistics or Statistics, Mathematics, Computer Science, Data Science, Machine Learning, or a related discipline. * Candidates must be detail-oriented, highly organized, and able to manage multiple tasks. * Candidates must be a self-motivated and have the ability to work independently as well as collaboratively with a team. * Ability to demonstrate strong analytical, quantitative, and programming skills is required. * Proficiency in at least one of the following languages SAS, R, or Python is preferred. * Excellent communication, presentation, and leadership skills are preferred. * Minimum GPA of 2.8 is required. * Completion of Undergraduate Sophomore year at accredited University is required. * Permanently authorized to work in the U.S., must not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually requires future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship. The anticipated base pay for this position is between $22.00/hr and $51.50/hr, but will be based on candidate's program year, discipline, degree and/or experience. This position is overtime eligible. Intern/Co-ops may be eligible to participate in Company employee benefit programs such as medical insurance, sick time, holiday pay, and the Company's consolidated retirement plan in accordance with the terms of the applicable plans. Housing stipend will be offered for those that qualify. This position is ineligible for severance. For additional general information on Company benefits, please go to: ********************************************* Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. #LI-Hybrid
$22-51.5 hourly 7d ago
Metrology Engineering Intern
MacRogenics 4.8
Rockville, MD Job
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.â¯ Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer.â¯Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe. The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization. Summary of Position We are seeking a motivated and detail-oriented Metrology Intern to join our team. As an intern, you will have the opportunity to gain experience in the field of metrology, working alongside experienced professionals to support our measurement and quality control processes. You will be responsible for assisting in the calibration, maintenance, and equipment records, ensuring that all devices meet industry standards and regulatory requirements. Responsibilities and Job Duties Assist with organizing of calibration and maintenance documentation. Coordinate the movement of documentation to offsite storage. Shadow troubleshooting and resolving issues related to equipment and instruments. Minimum Qualifications Education, Certifications & Experience Currently pursuing or recently completed a Bachelor's degree Light understanding of basic metrology concepts and tools (micrometers, calipers, gauges, etc.). Basic knowledge of tools such as Excel, or BMRAM. Strong analytical skills with attention to detail. Ability to work independently and as part of a team. Excellent communication skills, both verbal and written. Strong organizational skills and ability to manage multiple tasks simultaneously. Knowledge, Skills and Abilities Basic knowledge of tools such as Excel, or BMRAM. Strong analytical skills with attention to detail. Ability to work independently and as part of a team. Excellent communication skills, both verbal and written. Strong organizational skills and ability to manage multiple tasks simultaneously. Preferred Qualifications Previous experience in a manufacturing or quality assurance environment (preferred but not required). Strong understanding of basic metrology concepts and tools (micrometers, calipers, gauges, etc.). Additional Information The hourly rate of pay for this position is $21.50. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. Eligible intern employees may participate in the 401(k) plan with employer match and may receive the company holiday benefit if the holiday falls on a regularly scheduled workday. An intern will accrue one hour of sick leave for every 30 hours of working time. Interns are responsible for their own travel, housing, and living expenses. The pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. Statement MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email ******************** or call ************** and/or 711 for TTD/TTY service. Equal Opportunity Employer/Veterans/Disabled We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.
$21.5 hourly 18d ago
Associate Director of Supply Chain - Planning Systems and Master Data Management
Gilead Sciences, Inc. 4.5
Frederick, MD Job
We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. **Job Description** We are seeking a highly motivated individual to join us as an Associate Director of Supply Chain - Planning Systems and Master Data Management to be based in the United States. The Associate Director will be responsible for Planning Systems and Master Data Management. The Incumbent will lead a team of Planning-focused Business Process Owners, Planning System Administrators, and Data Stewards for management of both the systems and data required for Demand and Supply planning. The Associate Director drives business process guidance to internal customers and stakeholders to ensure integration with upstream and downstream activities. **Responsibilities of the** **Associate Director of Supply Chain - Planning Systems and Master Data Management includes:** + Works on problems of moderate to advanced complexity where analysis of situations or data requires an evaluation of intangible variables. + May be responsible for providing direction and organization of a team to support execution of the Supply Chain strategy (related to planning). + May be responsible for providing supervision, training, guidance, and performance management to department personnel. + Creates and maintains a positive working environment to ensure high productivity, employee engagement and performance. + Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results. + Manages Item Master Record Creation among team members. + Leads team for clean, timely and complete master data through governance model (Master Data Governance, Quality, Integrity, Cleansing and Conversion). + Drives Process ownership for Master Data (for ERP projects and sustainment activities) and oversees system validation and data testing. + Leads team in metrics, reporting, KPIs, WRKs, SOPs, Change Controls and CAPAs as needed. + Leads and drives process for Master Data accuracy. **Basic Qualifications:** + PhD with 5+ years of Supply Chain and/or Operations and/or External Manufacturing experience OR + MA / MS with 8+ years of Supply Chain and/or Operations and/or External Manufacturing experience OR + BA / BS Degree with 10+ years of Supply Chain and/or Operations and/or External Manufacturing experience **Preferred Qualifications:** + Strong experience working with global cross-functional team leadership and Master Data Management + Able to develop solutions to a wide range of complex problems, which require the regular use of ingenuity and innovation. + Exceptional verbal and written communication skills. + Experience with Advanced Planning Systems, Project Leadership, Program and Project Management, Business & Scientific Acumen, and System Development. + Able to create written communication that is properly structured providing clear, concise messages that draw well supported conclusions. + Strong negotiation skills. + Good organizational and time management skills, including working knowledge of basic project management tools and techniques. + Ability to interact effectively with senior management. + In-depth understanding and application of relevant principles, concepts, practices, and standards, along with a strong knowledge of industry practices. + Solid working knowledge of relevant regulatory guidance, including pharmaceutical GMPs and ICH Q7A. + Able to apply established organizational policies, and interpret, execute, and recommend modifications to department policies and procedures as needed. + May require familiarity with the technologies, strengths, and weaknesses of a wide variety of fine chemical and pharmaceutical manufacturers worldwide. + Demonstrates in-depth knowledge and proficiency across multiple practices within Supply Chain department, to understand, coordinate and communicate across the competing demands of each. Does this sound like you? If so, please apply today! \#IND123 \#LI-ML1 The salary range for this position is: $165,495.00 - $214,170.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit ****************** . Sign up to follow @KitePharma on Twitter at ************************** . **For jobs in the United States:** Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (********************************************************* YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION (*********************************************************************************************** Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. **For Current Kite Pharma Employees and Contractors:** Please apply via the Internal Career Opportunities portal in Workday. **Change The World With Us** Everyone at Kite is grounded by one common goal - curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work. We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don't take success for granted. While we've come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.
$165.5k-214.2k yearly 4d ago
Business Unit Leader, Early Intervention
Johnson & Johnson 4.7
Remote or Raynham, MA Job
* Job title Business Unit Leader, Early Intervention * Function Enterprise Management * Sub function Commercial Management * Category Senior Director, Commercial Management (PL10) * Date posted Mar 26 2025 * Requisition number R-005364 * Work pattern Hybrid Work This job posting is anticipated to close on Mar 26 2025. We may however extend this time period, in which case the posting will remain available on ******************* to accept additional applications. Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Enterprise Management Job Sub Function: Commercial Management Job Category: People Leader All Job Posting Locations: Raynham, Massachusetts, United States of America, US063 NJ Raritan - 920 US Hwy 202, US310 MA Boston - 4 Blackfan Circle Job Description: Johnson and Johnson is currently recruiting for a Business Unit Leader, Early Intervention within the Johnson & Johnson MedTech organization. This is a hybrid role available in multiple cities within New Jersey and Massachusetts. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from various locations to apply and encourage you to review the following locations where this opportunity is available: Raritan, NJ Raynham, MA Boston, MA Remote work options may be considered on a case-by-case basis and if approved by the Company. This leader will be responsible for overall national sales strategies, U.S. Marketing strategies, and Market Access and Pricing strategies for the Early Intervention platform. Additional responsibilities will include: * Own overall national sales strategy and lead all aspects of execution of strategy to achieve overall Early Intervention sales objectives. * Develop a long-term strategic vision and strategy for the Early Intervention business to continue to extend market leadership position * Responsible for market access and pricing strategies, including contracting, payor and large customer value proposition and engagement and development and execution of platform advocacy and policy strategy. * Develop, mentor, lead and engage Early Intervention Leadership team and their organizations to provide value and leadership through outstanding partner engagement; which includes communicating, influencing, and providing comprehensive solutions. * Build, analyze, develop and implement sales compensation framework and strategy. * Collaborate with Finance to build Gross, Net and Field Sales Business Plans. * Develop comprehensive Early Intervention expense budget, ensuring sales and supporting activities are within established budget objectives. * Review sales performance for overall business with CGCs, Presidents, VPs of Sales and Area Vice Presidents to identify areas for improvement, and carry out corrective action. * Build and maintain strong culture within organization that is fully defined and recognized by each level of the organization, with a focus on Diversity, Equity and Inclusion. * Lead and optimize the indirect sales organization Qualifications / Requirements: * Minimum of Bachelor's level degree is required; Business/Marketing/Finance related degree is preferred. MBA degree is preferred. * A minimum of 12 years of relevant experience, with a minimum of five years of people leadership. * Pharmaceutical Sales and Marketing Leadership experience is strongly preferred. * Proven leadership capability including the ability to lead and lead through change. * Track record of success working within a large organizational environment; enterprise approach to decision-making. * Solid understanding of customer, business intelligence and industry trends. * Strong business & financial acuity in understanding the needs and priorities of the broader business with a penchant for understanding the use of metrics/numbers to gauge overall performance. * Demonstrated track record as a Talent Champion in coaching, developing, retaining, acquiring and building a diverse pipeline of future talent. * Excellent listening, written, and oral communications skills; excellent organizational skills along with the ability to make presentations with positive results. * Up to 50% domestic travel will be required. About MedTech Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. #LI-Hybrid #LI-Remote The anticipated base pay range for this position is : 173,000 - 299,000 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. ******************************************** The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
$109k-146k yearly est. 6d ago
E-Learning Training Intern
MacRogenics 4.8
Rockville, MD Job
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe. The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization. Summary of Position We are seeking an enthusiastic and motivated intern to join our Quality Assurance (QA) team and assist in the development of computer-based training (CBT) modules for Good Manufacturing Practices (GMP), with a focus on deviation investigations and root cause analysis. This is a unique opportunity for an intern to gain hands-on experience in e-learning development, instructional design, and compliance training in a highly regulated industry. As an Instructional Design/E-Learning Development Intern, you will work closely with subject matter experts (SMEs) to create engaging, interactive, and effective training materials that ensure employees are equipped with the knowledge to handle deviations and perform root cause analysis within GMP guidelines. Responsibilities and Job Duties * Assist in Designing and Developing E-Learning Courses by collaborating with SMEs to develop CBT modules focused on deviation investigations and root cause analysis in GMP environments. This may include storyboarding and outlining course content, creating interactive scenarios, quizzes, and knowledge checks, designing graphics, infographics, and multimedia elements (e.g., videos, animations). * Work closely with GMP compliance experts and quality assurance teams to ensure technical accuracy in training content related to deviation management and root cause analysis. * Assist in applying the Kirkpatrick Training Evaluation Model to gather feedback from learners and stakeholders, evaluate the effectiveness of the training across all four levels (Reaction, Learning, Behavior, Results), and recommend improvements based on the findings. * Utilize E-Learning Authoring Tools (e.g., Articulate Storyline, Adobe Captivate, Lectora) to create visually appealing, interactive, and user-friendly online courses. * Assist in Content Development by creating clear, concise, and engaging content for training modules, ensuring alignment with GMP guidelines, deviation investigation procedures, and root cause analysis methods. * Test and Review Training Modules to ensure they function properly across various devices * Assist in uploading completed training materials to the Learning Management System (LMS) (e.g., MasterControl), ensuring proper tracking and reporting functionality for learner progress. Minimum Qualifications Education, Certifications & Experience Currently enrolled in or recently graduated from a degree program in Instructional Design, Educational Technology, Life Sciences (Biology, Chemistry, Biotechnology), Pharmaceutical Sciences, or a related field. No professional experience required, though any academic projects or internships related to instructional design, e-learning, or pharmaceutical training are a plus. Knowledge, Skills and Abilities * Familiarity with instructional design principles (ADDIE model or similar frameworks) and course development. * Experience with e-learning development tools (e.g., Articulate Storyline, Adobe Captivate) is a plus. * Proficiency with graphic design software (e.g., Adobe Photoshop, Canva) and video editing tools (e.g., Camtasia, Audacity) for creating and editing multimedia content. * Strong communication skills to work with subject matter experts and stakeholders, and to convey complex concepts clearly in training materials. * Ability to work independently and collaboratively in a team environment, with attention to detail and strong time management skills. * Proficient in Microsoft Office Suite (especially PowerPoint and Excel) for content development, planning, and project tracking. * Creative problem-solving skills to develop engaging, interactive, and effective training content. Preferred Qualifications * Familiarity with SCORM and AICC standards for e-learning. * Basic knowledge of HTML/CSS or JavaScript for custom e-learning content. * Prior experience in instructional design, adult learning principles, or developing e-learning content is a plus. Additional Information The hourly rate of pay for this position is $21.50. For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. Eligible intern employees may participate in the 401(k) plan with employer match and may receive the company holiday benefit if the holiday falls on a regularly scheduled workday. An intern will accrue one hour of sick leave for every 30 hours of working time. Interns are responsible for their own travel, housing, and living expenses. The pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. Statement MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email ******************** or call ************** and/or 711 for TTD/TTY service. Equal Opportunity Employer/Veterans/Disabled We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.
$21.5 hourly 19d ago
Scientist I/II
MacRogenics 4.8
Rockville, MD Job
MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe. The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization. Summary of Position This position is part of the Protein Science group within the Research department. The Scientist I/II will be responsible for the analysis of biomolecular interactions using Surface Plasmon Resonance (SPR) and Biolayer Interferometry (BLI) to analyze biomolecular interactions, primarily focusing on antibody-antigen binding kinetics in support of the biologics research pipeline. Additional roles include the purification of recombinant proteins and their characterization by HPLC and capillary electrophoresis. Responsibilities and Job Duties * Design, execute, and analyze SPR and BLI experiments to determine antibody affinities, kinetics, and epitopes. * Maintain SPR and BLI instruments * Purify proteins and perform routine analytical characterization * Confirm protein identity by Liquid Chromatography-Mass Spectrometry (LC-MS) * Conduct protein stability tests for lead molecule selection * Maintain timely and accurate records Minimum Qualifications Scientist I Education & Other Credentials * Bachelor's (BS/BA) in Biochemistry or a related scientific field of study with 3+ years of bench-related experience within industry and/or academia. OR * A Master's degree in Biochemistry or a related scientific field of study with 0 years of bench-related experience within industry and/or academia. Scientist II Education & Other Credentials * Bachelor's (BS/BA) in Biochemistry or a related scientific field of study with 5+ years of strong bench-related experience within industry and/or academia. OR * A Master's degree in Biochemistry or a related scientific field of study with 2+ years of strong bench-related experience within industry and/or academia. Knowledge, Skills and Abilities * Understanding of biophysical principles governing protein-protein interactions and binding kinetics * Hands-on experience with SPR and BLI instruments * Ability to handle multiple tasks and willing to collaborate with other teams * Excellent written and verbal communications skills * Maintain timely and accurate records Supervisory Responsibilities: No. Preferred Knowledge and Skills * Knowledge and experience about protein purification * Hand-on experience with AKTA chromatography system preferred * Hand-on experience with HPLC or LC-MS preferred Additional Information The annual rate of pay for this position ranges from $84,400 - $128,800 (Scientist I) and $94,300 - $143,800 (Scientist II). For non-exempt roles, and according to applicable regulations, there may be the possibility for overtime pay. This role is eligible for the Company's discretionary bonus and discretionary equity incentives. Eligible employees may participate in the Company's benefits programs, including medical / dental / vision / prescription coverage, employee wellness resources, 401(k) plan with employer match, access to an Employee Stock Purchase Plan, (ESPP), paid time off & paid parental leave benefits, and disability benefits. The annual pay rate range is described in good faith, and the Company believes is the range of possible compensation for this role at the time of this posting depending on the candidate's experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range, and this range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. Statement MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email ******************** or call ************** and/or 711 for TTD/TTY service. Equal Opportunity Employer/Veterans/Disabled We do not accept non-solicited resumes or candidate submittals from search/recruiting agencies.
$94.3k-143.8k yearly 7d ago

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Business Unit Leader, Early Intervention