Medical Writer Job Description
Medical writer
provides medical, scientific and technical expertise for regulatory and reimbursement submissions, contribute to scientific congresses and publications.
Medical Writer Duties & Responsibilities
To write an effective medical writer job description, begin by listing detailed duties, responsibilities and expectations. We have included medical writer job description templates that you can modify and use.
Sample responsibilities for this position include:
Collaborates within clinical biometrics and with clinical operations, clinical science, translational medicine, regulatory affairs, and other departments as required, on the development and/or revision of protocols, protocol amendments, clinical study reports, clinical sections of regulatory submission documents, Investigator’s Brochures, presentation material
Assisting with development and updating of Investigator’s Brochures and other regulatory documents
Preparation of clinical study reports or other regulatory documents supporting ongoing clinical development programs and their supportive appendices (or sections of these) by the incorporation of text, graphs, charts, tables, statistical analyses, in a clear and accurate manner consistent with the target audience and regulatory requirements
Editorial reviewing of documents for grammar, punctuation, and submission-compliant formatting
Providing overall medical writing support for ongoing programs
Work directly with the affiliates to ensure accurate and timely revisions and updates of required label information
Provide detailed review of global CERs to ensure accuracy and consistency
Support preparation of company core data sheets
Works directly with the affiliates as needed to develop approved, accurate and up-to-date text
Write and reference high-quality scientific manuscripts, slide presentations, posters, publications, surveys, brochures, newsletters, market research reports and educational materials for a managed markets/communications agency
Medical Writer Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Medical Writer
List any licenses or certifications required by the position: AMWA, CMPP, MWC, ISMPP, BELS, ELS, US, RAPS, EMWA/AMWA
Education for Medical Writer
Typically a job would require a certain level of education.
Employers hiring for the medical writer job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Medical, Writing, Life Sciences, Science, Life Science, Pharmacy, Education, English, Health, Communications
Skills for Medical Writer
Desired skills for medical writer include:
AMWA code of ethics and appropriate guidelines
Regulatory guidelines and medical/scientific/disease state terminology
Vascular space
US and international regulations
Requirements and guidance associated with scientific publications
Software programs in Windows environment
MS Word
Statistical concepts and techniques
Clinical operations
Regulatory submissions and US and international guidelines
Desired experience for medical writer includes:
Revise and update current materials
Own responsibility for all background preparation, literature searches, preparation of tables and graphs and interpretation of all health policy for assigned communications
Work closely with the team to ensure projects are managed appropriately and completed according to deadlines, highest quality and budget specifications
Present work in an organized and interesting manner, appropriate to clients¡¦ audience and professional expectations
Attend market research, industry meetings and training as required
Candidates should have an advanced degree in biomedical, life sciences, or related but more quantitative fields, such as health economics, biostatistics, and epidemiology
Medical Writer Examples
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Medical Writer Job Description
Job Description Example
Our company is looking for a medical writer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for medical writer
- Knowledgeable of US and international regulations, requirements and guidance associated with clinical regulatory document preparation and submissions
- Understands, assimilates, and productively interprets sources of information, with appropriate guidance/direction from product teams and/or authors
- Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers
- Manages all aspects of the medical writing processes for document development including, quality check, scheduling/timeline management, driving document preparation, coordinating document reviews and revisions, maintaining version control, and coordinating final reviews and approval
- Represents Medical Writing and Clinical Biometrics on cross-functional teams
- Develops, edits and reviews regulatory documents within agreed timelines that have high quality scientific content, organization, clarity, accuracy, format and consistency
- Stays current on medical writing best practices and regulatory guidelines
- Documenting study-specific Protocol Training (Kick-off Meeting Slides, Protocol Overview Presentations, ) by filling out and collecting signatures on group training forms as required
- Write, review, and edit clinical regulatory documents such as clinical study protocols, clinical study reports (CSRs), Investigator’s Brochures, and other documents as required for submissions
- Interpret statistical and clinical data with appropriate guidance/direction from teams and management
Qualifications for medical writer
- Advanced Scientific Degree (MSc., Ph.D., Pharm
- 3-5 years of experience in a technical and/or scientific writing position in the life sciences or healthcare economics fields
- Familiarity with medical terminology and clinical trial design (theoretical knowledge is sufficient)
- Familiarity with some reference manager software (EndNote, Reference Manager, Mendeley, Citavi)
- Excellent time and project management skills, team working skills
- PhD level degree in a scientific field with 2+ years professional experience in scientific and medical writing
2
Medical Writer Job Description
Job Description Example
Our growing company is looking for a medical writer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for medical writer
- Interact with internal and external authors (as needed) and key stakeholders to develop high‑quality documents
- Demonstrated ability to work both independently and in team environments with minimal supervision
- Comply with established company policies and procedures, and industry and regulatory guidelines
- Maintain broad awareness of developments in relevant therapeutic areas to ensure scientific and clinical relevance of written materials in specific project activities
- Monitor and manage own projects
- Lead clinical trial protocol development process with CPO/Region representative (Medical Advisor, statistician, regulatory, ..) or external authority recommended by customer
- Responsible, with the clinical trial team for preparation of high quality clinical study reports
- Incorporate input from authorities (Medical Advisor, Statistician, safety, DRA as appropriate) while ensuring that feasibility at site level, patient safety and trial objective
- Liaise with MedCom Medical Writers to review, further expand bibliography (list of publications) supporting protocol rationale
- Performs literature searches as needed for drafting document content
Qualifications for medical writer
- Bachelors Degree with 7+ years of experience supporting clinical research (MS, MA, or MPH with 5+ years of experience or PharmD, PhD, DVM, or MD with 3+ years of experience)
- Advanced degree (e.g., MS, MA, MPH, PharmD, PhD, DVM, MD) in scientific field of study (e.g., biological science, physical therapy, social science, engineering, or other related medical/scientific field)
- Bachelor’s Degree in health science or other area
- Bachelor’s Degree in either the Life or Physical Sciences (e.g., Biology, Chemistry, Physics, Pharmaceutics)
- 2+ years experience in pharmaceutical/clinical/imaging research preferred
- Demonstrated proficiency in medical, pharmaceutical, regulatory, clinical writing
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Medical Writer Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of medical writer. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for medical writer
- Responsible for developing the non-scientific portions of a standard research protocol (such as registration, record-keeping and regulatory compliance sections)
- Acts as Lead Medical Writer and performs competently on straightforward projects, with guidance from senior staff as required
- Production of scientific publications and other documents
- Independent preparation of protocols and clinical study reports (CSRs) including interpretation of clinical and pharmacokinetic data and statistical results
- Preparation and review patient safety narratives
- Participation in meetings with internal and external clients
- Project coordination and adherence to project timelines and budget, as appropriate
- Creating, modifying and finalizing Site Manuals, associated fillable forms, Quick Reference Guides and labels
- Creating, modifying and finalizing Quality Control (QC) Summaries
- Participating in Medical Writing Training activities, including creating/reviewing training modules
Qualifications for medical writer
- Understanding and knowledge of medical and/or clinical trial terminology desired
- Of at least 1 submission (i.e., accountable for the preparation of all summary
- Bachelor’s degree in a scientific discipline with at least 8 years of medical writing experience is required
- 5 – 8 + years of industry experience as a pharmaceutical medical writer
- Knowledge of, or aptitude for understanding, medicine
- Experience with research tools and approaches, such as reference management/publication planning databases
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Medical Writer Job Description
Job Description Example
Our company is growing rapidly and is hiring for a medical writer. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for medical writer
- Serves as medical writing lead on scientific publications or clinical regulatory documents
- Responsible for effective communication among team members
- Understands, assimilates, and interprets sources of information with appropriate guidance/direction from product teams and/or authors
- Bespoke research on healthcare interventions and therapeutic areas
- Analysing clinical studies
- Communication both via telephone, email and in-person with co-authors and clients
- Effectively communicates clinical regulatory document deliverables needed, writing process, and timelines to team members
- Understands, assimilates, and interprets sources of information with appropriate guidance/direction from development teams
- Serves as a subject matter expert within department for assigned therapeutic/product areas
- Understands, assimilates, and interprets sources of info with appropriate guidance/direction from product teams and/or authors
Qualifications for medical writer
- Proficiency in MS Office Suite (Word, Excel, Outlook, PowerPoint, Access)
- Demonstrated mastery of written English with experience in medical, scientific or technical writing fields (at least 1 year)
- A writing exercise is required as part of the candidate evaluation process
- 3-5 years of relevant pharmaceutical and/or medical device industry experience, with at least 3 years of specific medical writing experience in the pharmaceutical industry (including development of clinical study outlines, protocols, study reports, investigator brochures, and IND/NDA sections)
- Working knowledge of ICH guidelines, GCP, CTD
- Bachelors degree in a scientific discipline plus a minimum of 5-7 years industry experience
5
Medical Writer Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of medical writer. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for medical writer
- Working independently to perform background research, writing and editing clinical and regulatory documents through draft, review, finalization and sign-off stages
- Collaboration and strategic partnership with Global Therapeutic Area Leads, Global Clinical Program Directors and Clinical Safety Physicians to ensure understanding of program strategy and the nature of medical writing services required to deliver on company objectives
- Provides input into medical writing vendor selection, defines the scope of work to be outsourced, and is responsible for medical writing vendor oversight on the outsourced deliverables
- Develop and update medical communication content per clinical development program, publications, data releases, congress activity, customer inquiry trends, treatment landscape, market events
- Conduct literature searches, author medical communications content and perform data accuracy reviews for medical communications content on oncology assets
- Write and edit clinical study documents
- Act as the primary client contact for medical writing projects
- Partner with sponsors to deliver quality documents on time
- Mentor and train junior medical writing staff
- Troubleshooting strategic content- and process-related issues with other departments, , Editing, Creative Services, Marketing, as necessary
Qualifications for medical writer
- Masters degree in a scientific discipline plus a minimum of 2-5 years industry experience
- Ph.D, Pharm.D, or equivalent in a scientific discipline plus a minimum of 1-2 years industry experience
- The ideal applicant would have training in the biomedical sciences, particularly in areas such as biology, pharmacology, chemistry and biotechnology, experience in technical written communication
- This position requires translating technical information from mixed sources into written information suitable for an audience of regulatory authorities and clinicians
- At least 6+ years operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization
- Demonstrates excellent scientific writing skills, experienced medical writer a plus