Medical Writing Operations Specialist II

Exelixis Inc. • Alameda, CA

65d • $102,000 - $144,000

About The Position

This role will perform quality review of regulatory documents to ensure content accuracy and consistency. Document scope includes but is not limited to clinical and nonclinical CTD Module 2 summaries, briefing documents, protocols, investigator brochures, clinical study reports (CSRs), and other types of cross-functional documents and reports.

Requirements

• BS/BA degree in a related discipline and a minimum of 5 of related experience; or,
• MS/MA degree in a related discipline and a minimum of 3 years of related experience; or,
• Equivalent combination of education and experience.
• Experience in Biotech/Pharmaceutical industry required.
• 3 to 5 years of quality assurance, clinical development, or laboratory experience; or equivalent experience in the pharmaceutical industry.
• Strong working knowledge of drug development process, regulatory guidelines, industry standards, and best practices.
• Experience reviewing documents for regulatory submissions (e.g., INDs, NDAs, BLAs, sNDAs, TIIVs, CTDs, clinical protocols, CSRs).
• Knowledge of AMA style and medical terminology.
• Familiar with VeevaRIM or other document management system and document authoring technologies.
• Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates.
• Manages time to complete tasks and achieve results within established timelines. Takes pride in delivering high quality work.
• Strong attention to detail and comfortable working in a fast-paced environment.
• Ability to work with cross-functional teams in a matrixed team environment, collaborate with a wide variety of team members, and relate effectively to people at all levels of the organization.
• Team player who demonstrates initiative and applies good judgement.
• Embraces change and has a flexible and innovative mindset.

Nice To Haves

• BELS certification is a plus.
• Familiarity with therapeutic area of oncology is preferred.

Responsibilities

• Ensure compliance with company and industry standards as well as regulatory expectations, supporting the drug development pipeline through high-quality regulatory submissions that contribute to successful product approvals.
• Ensure that data and information in complex documents are accurate, consistent with source documents, internally consistent, and meet company standards of style and quality.
• Edit regulatory documents according to company style guide and American Medical Association (AMA) style.
• Monitor timelines for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk.
• Contribute to the development of process improvements, authoring or editing tools, and the development or revision of internal policies, procedures, and job aids.
• Participate actively in group meetings and in cross-departmental project teams as needed.
• Other duties as assigned.

Benefits

• Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
• Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 1,001-5,000 employees