Sr. Medical Writer
The Senior Medical Writer will be responsible for authoring and revising clinical and regulatory documents for submission to the FDA and other agencies, and to support other clinical communication efforts including abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals.
- Author, revise, and edit clinical study reports, clinical study protocols, investigator’s brochures, clinical data summaries, and other medical/regulatory documents
- Develop and author abstracts and slides or posters presenting clinical study data to medical congresses and the development of primary manuscripts for publication in peer-reviewed journals
- Represent medical writing on project and program teams through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departments
- Develop and manage the overall document development process including timelines, document reviews, and approvals in adherence with company standard operating procedures and regulatory guidance
- Contributes to clinical trial registry postings and results disclosures on US and EU platforms
- Minimum of 2 years (MS/PhD) or 5 years with (BA/BS) medical writing experience in the biopharmaceutical industry
- Experience preparing clinical regulatory documents and scientific publications is crucial
- Must have a solid understanding of FDA/ICH guidelines and GCPs
- The ability to interpret statistical and clinical data
- Prior NDA/BLA/MAA submission experience, including eCTD, preferred
- Familiarity with clinical trial transparency requirements, including ClinicalTrials.gov and EudraCT standards, preferred
- Must have strong written and verbal communication skills, and expert abilities in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat preferred
- Must have the ability to coordinate and prioritize multiple projects in a fast-paced environment with little supervision
- Background in oncology drug development is a plus
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics 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.