We are currently seeking a Medical Writer to write and revise clinical documents for submission to the FDA and other regulatory agencies, and to support other clinical communication efforts including abstracts and presentations for medical congress meetings and manuscripts for peer-reviewed journals.
- Write and edit clinical study reports, study protocols, investigator’s brochures, clinical data summaries, and other medical/regulatory documents.
- Represent medical writing on project teams through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departments.
- Develop and manage timelines for document development.
- Participate in the development of abstracts and slides or posters presenting clinical study data to medical congresses and the development of primary manuscripts for peer-reviewed journals.
- This position requires a bachelors degree in a life sciences discipline and a minimum of 2 years biopharmaceutical industry experience.
- Experience preparing clinical regulatory documents and scientific publications is crucial.
- Prior NDA/BLA/MAA submission experience required; eCTD preferred.
- Must have a solid understanding of FDA/ICH guidelines and GCPs.
- 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.
- Background in oncology drug development is a plus.
- Experience with early-stage drug development (phase 1) is desirable.
Seattle Genetics is an Equal Opportunity Employer