Assoc Scientific Regulatory Writing Director

SUMMARY / JOB PURPOSE

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.

ESSENTIAL DUTIES / 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.

SUPERVISORY RESPONSIBILITIES

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS

Education :

Experience :

Knowledge, Skills and Abilities :

Work Environment / Physical Demands

If you like wild growth and working with happy, enthusiastic over-achievers, you\'ll enjoy your career with us!

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $148,500 - $209,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, 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.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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