Associate Regulatory (Medical Writing) Scientific Communications Director
ExelixisRemote
Posted March 13, 2026
148500 - 209500 USD
Full Time
About the Company
Every Exelixis employee is united in an ambitious cause: to transform science into new treatments that give cancer patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. As a diverse, growing team, everyone at Exelixis plays a role in advancing our mission through our innovative drug discovery, development and commercialization efforts. We take pride in our shared purpose, knowing the magnitude of our impact expands with every medicine we create and every form of cancer tumor type we treat. After operating in the challenging biotech sector for nearly three decades, we've evolved into a multi-platform cancer company with a proven track record of resiliency in the face of adversity. The success of our flagship commercial product set us up on our journey to discover and develop next-generation cancer treatments, driven by our relentless pursuit of results for the patients we serve. Cancer is our cause. Make it yours, too. Please see our Community Guidelines: bit.ly/4iBzJU0 For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.
Job Description
Leads content development for various regulatory and clinical documents to support multiple assets across all phases of asset development. Develops, reviews, and edits content for clinical and nonclinical summaries, briefing documents, regulatory responses, protocols, investigator brochures, clinical study reports, and other types of complex cross-functional documents and reports.
Requirements
- B.S./B.A. degree in a related discipline and a minimum of eleven years of related experience including industry
- M.S./M.A. degree in a related discipline and a minimum of nine years of related experience including industry
- Ph.D. in a related discipline and a minimum of five years of related experience including industry
- Active AMWA member with certificate or certification preferred; BELS certification a plus
- Experience in Biotech/Pharmaceutical industry preferred
- Prior regulatory/medical/technical writing experience within the biotech, pharmaceutical, or CRO industry
- Experience and significant participation in leading content development for regulatory and clinical documents for regulatory submissions
- Experience and use of electronic literature tools to obtain scientific/medical abstracts and publications
- Familiarity with therapeutic area of oncology
- Advanced knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidance, and GCP standards
- Advanced knowledge of AMA style, medical terminology, and clinical data analysis
Benefits
- 401k plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Sales-based incentive plan
- Opportunity to purchase company stock
- Long-term incentives
- 15 accrued vacation days in the first year
- 17 paid holidays including a company-wide winter shutdown in December
- Up to 10 sick days throughout the calendar year