Regulatory CMC Technical Writer

Summary:

The Chemistry Manufacturing and Controls (CMC) Technical Writing function resides organizationally within Regulatory Affairs. The CMC Technical Writer is responsible for collaborating cross-functionally to write/edit CMC regulatory documentation and electronic regulatory submissions, ensuring consistency of formatting, styles and messaging.

Responsibilities:

• Coordinate regulatory CMC document preparation in collaboration with the Global Regulatory CMC Lead and subject matter experts on CMC Team and in accordance with CTD requirements
• Ensure formatting, vocabulary and styles are consistent within and across CTD documents
• Maintain and improve regulatory document preparation best practices and processes
• Assist in development of database for Health Authority questions and responses; responsible for maintaining in current state
• Prepare and maintain writing guides for IND, CTA, BLA, NDA
• Participate in Editorial Style committee

Qualifications:

• BA/BS in Life Sciences with 2-5 years experience or MS/PhD with 0-2 years experience
• Familiarity with eCTD, FDA/ICH guidelines and cGMP
• Proficient in Microsoft Word, MS Project, Adobe Acrobat, Excel and PowerPoint
• Experience managing timelines and document preparation/formatting for regulatory documents, technical reports, or equivalent, relevant experience; supporting a BLA filing is strongly preferred
• Self-directed and motivated individual who is able to work effectively with limited direction in a complex, fast-paced environment
• Strong written and oral communication skills, with ability to work well cross-functionally with various people and groups
• Highly organized and detail oriented with effective time management and ability to prioritize projects in a fast-paced environment

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.