Senior Medical Writer job description
Updated March 14, 2024
11 min read
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Example senior medical writer requirements on a job description
Senior medical writer requirements can be divided into technical requirements and required soft skills. The lists below show the most common requirements included in senior medical writer job postings.
Sample senior medical writer requirements
- Bachelor's degree in a scientific field
- At least 5 years of experience in medical writing
- Excellent knowledge of relevant regulatory guidelines
- Exceptional written and verbal communication skills
- Proficiency in MS Office Suite
Sample required senior medical writer soft skills
- Strong organizational and planning abilities
- Ability to work independently and collaboratively
- Detail-oriented and solutions-driven mindset
- Ability to work in a fast-paced environment
Senior Medical Writer job description example 1
Veristat senior medical writer job description
For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.
Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.
We do things differently than large CROs and would love to have you join our Veristat team!
The Senior Medical Writer independently plans and prepares a variety of clinical documents necessary for all phases of clinical drug and device development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include Module 2 clinical summaries of marketing applications, integrated summaries of safety and efficacy, agency meeting briefing packages, clinical study reports, study protocols, investigator's brochures, aggregate safety reports, and manuscripts.
As a Senior Medical Writer You Will...
Conduct overall planning of the clinical sections of global submissions. Work with a manager to develop timelines and resource plans for the clinical sections of a submission or for implementation of communication strategy. Review statistical analysis plans as required. Perform “peer” review of documents written by other medical writers as required. Keep management informed on progress of documents and other project-related information. Assist management in projecting resources and perform administrative duties as requested. Work independently with the sponsor representative(s) with regard to document planning, review, revision, and finalization. Documents are to be completed within a time period that supports project needs and deadlines. Furthermore, documents are to be of high quality and scientifically accurate, and are to reflect a consensus among team members that is acceptable to all appropriate reviewers. Documents must meet International Conference on Harmonisation (ICH) guidelines and company document standards unless required otherwise by client and agreed per procedure.
Experience + Requirements
Bachelor's Degree in a science or related field. Minimum of 5 years of medical writing experience in a CRO, pharmaceutical, or biotechnology setting. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis. Working knowledge of ICH and other regulatory guidelines required. The ability to accurately and clearly present clinical data; strong verbal, written, and interpersonal communication skills; and proficiency in Microsoft Word are required. Broad knowledge of global pharmaceutical regulatory requirements required, and experience in clinical research or other areas of the pharmaceutical industry preferred. Excellent regulatory writing skills (e.g., English usage) and a keen attention to detail also are required.
#LI-Remote
Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision making process.
Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.
We do things differently than large CROs and would love to have you join our Veristat team!
The Senior Medical Writer independently plans and prepares a variety of clinical documents necessary for all phases of clinical drug and device development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include Module 2 clinical summaries of marketing applications, integrated summaries of safety and efficacy, agency meeting briefing packages, clinical study reports, study protocols, investigator's brochures, aggregate safety reports, and manuscripts.
As a Senior Medical Writer You Will...
Conduct overall planning of the clinical sections of global submissions. Work with a manager to develop timelines and resource plans for the clinical sections of a submission or for implementation of communication strategy. Review statistical analysis plans as required. Perform “peer” review of documents written by other medical writers as required. Keep management informed on progress of documents and other project-related information. Assist management in projecting resources and perform administrative duties as requested. Work independently with the sponsor representative(s) with regard to document planning, review, revision, and finalization. Documents are to be completed within a time period that supports project needs and deadlines. Furthermore, documents are to be of high quality and scientifically accurate, and are to reflect a consensus among team members that is acceptable to all appropriate reviewers. Documents must meet International Conference on Harmonisation (ICH) guidelines and company document standards unless required otherwise by client and agreed per procedure.
Experience + Requirements
Bachelor's Degree in a science or related field. Minimum of 5 years of medical writing experience in a CRO, pharmaceutical, or biotechnology setting. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis. Working knowledge of ICH and other regulatory guidelines required. The ability to accurately and clearly present clinical data; strong verbal, written, and interpersonal communication skills; and proficiency in Microsoft Word are required. Broad knowledge of global pharmaceutical regulatory requirements required, and experience in clinical research or other areas of the pharmaceutical industry preferred. Excellent regulatory writing skills (e.g., English usage) and a keen attention to detail also are required.
#LI-Remote
Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision making process.
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Senior Medical Writer job description example 2
Ortho Clinical Diagnostics senior medical writer job description
The Career Potential
Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.
Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
As we continue to grow, we are seeking a Senior Medical Writer in the Medical & Clinical Affairs department. Under supervision of the Sr. Manager, Medical & Clinical Affairs, the Senior Medical Writer is responsible for generating scientific and medical content including but not limited to white papers, journal articles, educational materials, Scientific Validity Reports, Clinical Performance Reports for In Vitro Diagnostic Regulation (IVDR), and study reports.
This position is located in Raritan, NJ or Rochester, NY with the option to work remotely a certain percentage of time.
The Responsibilities
Liaise with internal stakeholders across multiple functions to create content that meets project objectives.Conduct literature searches and extract relevant information for inclusion in scientific writing.Extract key information from study reports to generate scientific articles, white papers, and/or journal manuscripts.Produce copy for websites and other media platforms that connects with health care professionals.Produce presentation content for internal and external scientific and/or medical education.Perform other work-related duties as assigned.
The Individual
PhD required in the field of life sciences Knowledge of content in AMA Manual of Style. Medical Writer Certification through American Medical Writers Association (AMWA) or similar association preferred.10+ years of medical writing experience for the pharmaceutical, in vitro diagnostic, and/or medical device industries including journal manuscript development Experience conducting scientific research.Ability to present content in a way that optimizes readership.Proven ability to combine scientific knowledge with excellent writing skills.Proven planning skills and ability to manage multiple projects and timelines simultaneously.Proven interpersonal, leadership, organizational and effective time management skills.Microsoft Office proficiency.Ability to work independently and within a cross-functional team environment to build solid and productive relationships.Minimal travel up to 10% on an annual basis
EOE/AA Disability/Veteran
#LI-SC1
Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.
Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
As we continue to grow, we are seeking a Senior Medical Writer in the Medical & Clinical Affairs department. Under supervision of the Sr. Manager, Medical & Clinical Affairs, the Senior Medical Writer is responsible for generating scientific and medical content including but not limited to white papers, journal articles, educational materials, Scientific Validity Reports, Clinical Performance Reports for In Vitro Diagnostic Regulation (IVDR), and study reports.
This position is located in Raritan, NJ or Rochester, NY with the option to work remotely a certain percentage of time.
The Responsibilities
Liaise with internal stakeholders across multiple functions to create content that meets project objectives.Conduct literature searches and extract relevant information for inclusion in scientific writing.Extract key information from study reports to generate scientific articles, white papers, and/or journal manuscripts.Produce copy for websites and other media platforms that connects with health care professionals.Produce presentation content for internal and external scientific and/or medical education.Perform other work-related duties as assigned.
The Individual
PhD required in the field of life sciences Knowledge of content in AMA Manual of Style. Medical Writer Certification through American Medical Writers Association (AMWA) or similar association preferred.10+ years of medical writing experience for the pharmaceutical, in vitro diagnostic, and/or medical device industries including journal manuscript development Experience conducting scientific research.Ability to present content in a way that optimizes readership.Proven ability to combine scientific knowledge with excellent writing skills.Proven planning skills and ability to manage multiple projects and timelines simultaneously.Proven interpersonal, leadership, organizational and effective time management skills.Microsoft Office proficiency.Ability to work independently and within a cross-functional team environment to build solid and productive relationships.Minimal travel up to 10% on an annual basis
EOE/AA Disability/Veteran
#LI-SC1
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Senior Medical Writer job description example 3
Premier Research senior medical writer job description
At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all. We're a community of 2,000 people in more than 20 countries delivering unmatched expertise, operational skills, and dedication to meet the most challenging needs facing clinical trials today.
We're looking for a Senior Medical Writer to join our Medical Writing team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you'll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.
We can accommodate office based; home based or a hybrid mix.
The Senior Medical Writer is responsible for authoring and managing the review and approval of moderate and complex clinical and regulatory documents including but not limited to clinical study reports, protocols, investigator brochures, clinical sections of the Common Technical Document, and other clinical documents. Converts scientific data into clear, scientifically sound, well-structured regulatory documents intended for global health authorities and stakeholders, in accordance with relevant styles and guidelines. This role provides guidance and mentoring to the Associate Medical Writer and Medical Writer I/II positions.
What You'll Be Doing:
Project manage assignments Independently write and format clinical and regulatory documents Review and approve clinical and regulatory documents including, but not limited to: synopses and protocols, clinical study reports, in-text tables, appendices, addendums, study plan outlines, and documents for regulatory submissions (e.g., Investigational New Drug applications, sections of marketing applications, investigator brochures, or other clinical and regulatory documents) Ensure timeline adherence for each assigned project, provide project status updates on a regular basis and carry out contractual obligations for each assigned project Work on multiple projects and/or project teams at one time (dependent on complexity and time commitment for each project) in collaboration with project managers and clients Interpret and summarize clinical data as needed to prepare documents Review all source documents, perform literature searches, and interact with internal team members and external clients to develop a thorough understanding of project background, timelines, and goals Advise clients on appropriate document preparation and the basic regulatory requirements of various types of documents Aid in study design during protocol development and regulatory compliance throughout all documents Write Integrated Summaries of Safety and Efficacy (ISS and ISE), and guide more junior writers to assist in their preparation Edit and perform quality control reviews for documents for other Medical Writers Identify and solve problems relating to medical writing issues Coordinate with internal team members to develop deliverables for clients Contribute to the development and maintenance of the working practices, procedures, and templates for the Medical Writing department Assist in the review of statistical analysis plans prior to database lock and provide feedback to the team when appropriate Effectively facilitate data and document review meetings with internal teams and clients, as necessary Manage the efforts of other writers and mentor more junior writers What we are searching for: Bachelor's degree, or international equivalent, from an accredited institution in a scientific discipline, journalism, or English; MS or PhD in a scientific or medical discipline preferred BA/BS and demonstrated experience in medical/regulatory writing; or MS coupled with proven experience in medical/regulatory writing; or PhD and experience in medical/regulatory writing International experience desirable Depth of industry and drug development knowledge Expert in literature search techniques Strong knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation Superior working knowledge of software programs in Windows environment with excellent proficiency in word processing, flow diagrams, and spreadsheets Ability to learn fast, to convert relevant scientific data/information into high quality summaries and reports Excellent organizational, writing, communication, and time management skills needed to manage multiple ongoing projects and/or other writers simultaneously Well-developed analytical skills and strong knowledge of medical terminology Experience across various therapeutic areas and phases
Why choose Premier Research?
Premier Research is more than a company - it's a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. Our cultural anchors - Caring & Empathy, Empowerment, Aspiration, One Team - mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.
#LI-JD1
#Remote
We're looking for a Senior Medical Writer to join our Medical Writing team that is passionate about improving healthcare through innovative clinical research. As a member of the Premier Research team, you'll help create tangible solutions for patients in need while building cross-functional partnerships that enable your growth and success.
We can accommodate office based; home based or a hybrid mix.
The Senior Medical Writer is responsible for authoring and managing the review and approval of moderate and complex clinical and regulatory documents including but not limited to clinical study reports, protocols, investigator brochures, clinical sections of the Common Technical Document, and other clinical documents. Converts scientific data into clear, scientifically sound, well-structured regulatory documents intended for global health authorities and stakeholders, in accordance with relevant styles and guidelines. This role provides guidance and mentoring to the Associate Medical Writer and Medical Writer I/II positions.
What You'll Be Doing:
Project manage assignments Independently write and format clinical and regulatory documents Review and approve clinical and regulatory documents including, but not limited to: synopses and protocols, clinical study reports, in-text tables, appendices, addendums, study plan outlines, and documents for regulatory submissions (e.g., Investigational New Drug applications, sections of marketing applications, investigator brochures, or other clinical and regulatory documents) Ensure timeline adherence for each assigned project, provide project status updates on a regular basis and carry out contractual obligations for each assigned project Work on multiple projects and/or project teams at one time (dependent on complexity and time commitment for each project) in collaboration with project managers and clients Interpret and summarize clinical data as needed to prepare documents Review all source documents, perform literature searches, and interact with internal team members and external clients to develop a thorough understanding of project background, timelines, and goals Advise clients on appropriate document preparation and the basic regulatory requirements of various types of documents Aid in study design during protocol development and regulatory compliance throughout all documents Write Integrated Summaries of Safety and Efficacy (ISS and ISE), and guide more junior writers to assist in their preparation Edit and perform quality control reviews for documents for other Medical Writers Identify and solve problems relating to medical writing issues Coordinate with internal team members to develop deliverables for clients Contribute to the development and maintenance of the working practices, procedures, and templates for the Medical Writing department Assist in the review of statistical analysis plans prior to database lock and provide feedback to the team when appropriate Effectively facilitate data and document review meetings with internal teams and clients, as necessary Manage the efforts of other writers and mentor more junior writers What we are searching for: Bachelor's degree, or international equivalent, from an accredited institution in a scientific discipline, journalism, or English; MS or PhD in a scientific or medical discipline preferred BA/BS and demonstrated experience in medical/regulatory writing; or MS coupled with proven experience in medical/regulatory writing; or PhD and experience in medical/regulatory writing International experience desirable Depth of industry and drug development knowledge Expert in literature search techniques Strong knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation Superior working knowledge of software programs in Windows environment with excellent proficiency in word processing, flow diagrams, and spreadsheets Ability to learn fast, to convert relevant scientific data/information into high quality summaries and reports Excellent organizational, writing, communication, and time management skills needed to manage multiple ongoing projects and/or other writers simultaneously Well-developed analytical skills and strong knowledge of medical terminology Experience across various therapeutic areas and phases
Why choose Premier Research?
Premier Research is more than a company - it's a community of people that truly care about one another, about our clients, and about our mission of furthering research to improve the lives of patients in critical need. Our cultural anchors - Caring & Empathy, Empowerment, Aspiration, One Team - mirror the flexibility and trust that our team embodies. As a Premier team member, you have the power to make an impact, regardless of job title and location. Our dedication to biotech and specialty pharma is unlike any other. We provide our staff with innovative technologies and continuous learning opportunities so that they have the tools they need to be successful.
At Premier Research, our mission is to improve healthcare by transforming life-changing ideas into new medical treatments that address the unmet needs of a diverse global population. Achieving this is impossible without creating a culture where our employees are given the power to think creatively, challenge ideas, and solve complex problems fearlessly. Through a commitment to diversity, equity, inclusion, and empowerment, we strive to create a community of belongingness where our differences are welcomed and celebrated. It fuels our innovation and better connects us to the patients, physicians, and customers we serve.
#LI-JD1
#Remote
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Updated March 14, 2024
Updated March 14, 2024