The senior medical writer will be responsible for independently authoring and revising clinical and regulatory documents for submission to the fda and other agencies, and to support other clinical communication efforts, including the development of abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals.
This position can be located in bothell, wa or u.sRemote
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 5 years of experience in the biopharmaceutical industry, with 3 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 coordinate and prioritize multiple projects in a fast-paced environment with limited supervision
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 familiesBenefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much moreTo learn more about seagen, please visit www.seagen.com.
Seagen is an equal opportunity employerAll 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.