It is the Medical Writer’s role to manage various writing activities in coordination with the Clinical/Medical team. The Medical Writer will ensure consistency across documents, improve document quality and provide guidance on writing style. The Medical Writer will assist in the writing and review of publications, abstracts and clinical trial-related documents. The ideal candidate will have 7 + years of medical writing experience in a similar environment.
The Medical Writer will report to the Chief Medical Officer and work closely with the Clinical team.
Key Duties and Responsibilities
Manage medical writing activities by identifying contributors, reviewers and maintaining agreed upon timelines
- Plan, write, edit, format, and finalize clinical program and trial-related documents, including but not limited to, IB, protocol/amendments, consent, clinical study reports, statistical analysis plans, along with Tables/Listings/Figures, regulatory submission documents including annual reports, and publications/abstracts/presentations)
- Performs on-line clinical literature searches as needed
- SOP and Guidance review and writing
- Experience in developing style writing manuals or similar; familiarity with the AMA style guide
- May also participate in R&D and other departmental writing/review activities as time allows
- Work effectively across functional teams and represents medical writing
- Other duties as assigned.
Desired Education, Skills, and Experience
- Bachelor’s or Master’s degree in the science or writing discipline
- Minimum 7 years related medical writing experience in biotech or similar environment
- Demonstrates strong writing skills with sample work
- Extensive knowledge of federal regulations, Good Clinical Practices, ICH-E3 and other guidance, as well as applicable US/International regulatory processes related to document preparation and production (including eCTD).
- Broad knowledge of clinical development and statistics applications to the presentation of clinical data is a plus
- Demonstrates strong organizational skills and ability to work well in a cross-functional team environment
- Knowledgeable on documentation requirements for manuscript submissions to scientific and medical journals
- Maintains familiarity with current industry practices, regulatory requirements, and guidance that affect medical writing
- Strong ability to read, write and interpret the English language
- Strong attention to detail
- Strong proficiency in Word, Excel, PowerPoint, the use of templates, email and internet
Location: San Mateo, California
Department: Medical Writing and Clinical
Min. Experience: Senior Level