Assoc Scientific Regulatory Writing Director

Exelixis • Alameda, CA

109d • $148,500 - $209,500

About The Position

Leads content development for various regulatory and clinical documents to support multiple assets across all phases of asset development. Examples include clinical and nonclinical summaries for IND/NDA/BLA/MAA, briefing documents, regulatory responses, protocols, investigator brochures, clinical study reports, and other types of complex cross‑functional documents and reports as needed.

Requirements

• BS/BA degree in related discipline and a minimum of eleven years of related experience including industry; or, MS/MA degree in related discipline and a minimum of nine years of related experience including industry; or, PhD in related discipline and a minimum of five years of related experience including industry; or Equivalent combination of education and experience.
• 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 (e.g., IND/NDA/BLA/MAAs, clinical protocols, CSRs, IBs).
• 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.

Nice To Haves

• Strong interpersonal skills and ability to accommodate differing views to actively support the development of an agreed upon resolution.
• Demonstrates clear and effective verbal and written communication.
• Engages internal stakeholders to establish productive collaborative relationships.
• Applies knowledge of organizational goals and objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.
• Leads self and others; acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.

Responsibilities

• Independently leads content development for regulatory and clinical documents by composing (writing), developing, reviewing, and editing content.
• Integrates various sources of information into a uniform style and presentation for the intended audience.
• Incorporates diverse reviewer feedback while ensuring high quality of content organization, including completeness, clarity, coherence, conciseness, consistency, and accuracy.
• Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed to create descriptive text and in‑text tables.
• Assigns and supervises partner regulatory editors for all document tasks unrelated to writing.
• Proposes and manages timelines for the document development process from initiation through approval.
• Oversees the assembly of appendices for regulatory submission documents as needed.
• Serves as the primary writing contact on regular and ad hoc study/program/asset or project teams.
• Provides writing guidance to internal teams based on organizational goals and company policy, with responsibility for results.
• Peer reviews project work and training materials/guidelines drafted by Regulatory Science Communications team members.
• Contributes to SOP and work instruction development and review for the Regulatory Science Communications team.
• Other duties as needed.

Benefits

• 401k plan with generous company contributions
• Group medical, dental and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Opportunity to purchase company stock
• Long-term incentives
• 15 accrued vacation days in their first year
• 17 paid holidays including a company-wide winter shutdown in December
• Up to 10 sick days throughout the calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees