Principal Medical Writer
The Principal Medical Writer will be responsible for independently authoring and revising clinical and regulatory documents for submission to the FDA and other agencies, and to lead other clinical communication efforts, including the development of abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals. The Principal Medical Writer will be expected to support multiple studies, programs, and/or indications.
Includes but not limited to
- Leads the development and authoring of clinical protocols, clinical study reports, investigator brochures, and clinical summaries in support of regulatory filings
- Leads the development and authoring of abstracts, posters, slides of clinical study data at medical congresses and the development of primary manuscripts for publication in peer-reviewed journals
- Provides medical writing support for briefing documents, information requests, nonclinical summaries, and additional documents intended for submission to HAs
- Facilitates document review committee meetings and issues resolution
- Provides project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents
- Organizes, conducts, and leads cross-functional document development meetings
- Closely interacts with statistics and programming departments in the development of statistical analysis plans and design of statistical outputs
- Routinely engages clinical research and biostatistics to gain comprehensive understanding of compound and the design, objectives, and results of clinical trials to enable accurate and effective communication to varied audiences
- Represents medical writing on study/project teams and contributes to program strategy, through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departments
- Minimum of 8 years of experience in the biopharmaceutical industry, with 5 years of direct medical writing experience; advanced degree(s)/academic research/transferable skills may be considered in lieu of industry experience
- Masters or doctorate degree in life sciences
- Excellent written and verbal communication skills with the ability to interpret and present scientific data
- Ability to work cross-functionally
- Skilled in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat
- Awareness of FDA regulations, ICH guidelines, Good Clinical Practices and the drug development process
- Must have the ability to independently coordinate and prioritize multiple projects in a fast-paced environment
As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.
Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.