Senior Director, Scientific Regulatory Writing

SUMMARY/JOB PURPOSE:

Asset lead. Expert at content development for the asset, including knowledge of current developments and well‑informed of scientific literature. Oversees less experienced writers in the development of content for regulatory documents to support the asset. 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 cross‑functional documents and reports. Composes and develops content, reviews, and edits these documents as needed. Proposes and leads efforts to improve document development processes. Provides guidance to other Exelixis staff or personnel at partner organizations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Oversees less experienced writers in the planning, organization, and completion of document deliverables to support regulatory submissions for the asset.

• Supports direct reports in personal skill growth and career development.

• Participates in cross‑functional teams for the asset and collaborates with team members to propose and manage timelines.

• Prepares drafts of documents as needed, developing content and integrating various sources of information into a uniform style and language for regulatory compliance.

• Proposes opportunities for process improvement and leads projects to enhance efficiency and optimize the use of resources.

• Advises cross-functional teams on regulatory writing concerns and responsibilities.

• Serves as the asset’s regulatory writing expert on regular and ad hoc study, program, or project teams or guide less experienced writers in those responsibilities.

• Assists direct reports in determining methods and procedures on new assignments.

• Other duties as needed.

SUPERVISORY RESPONSIBILITIES:

• Directly supervises less experienced writers to prepare asset‑related content. May indirectly supervise employees through a dotted‑line structure or via other subordinate supervisors.

• Supervises staff, including hiring, reviewing performance, and recommending salary increases, promotions, transfers, demotions, or terminations.

• May support and direct the work of contract writers.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• PhD in a related discipline and a minimum of twelve years of related experience preferred; or,

• MS/MA degree in related discipline and a minimum of thirteen years of related experience; or,

• BS/BA degree in related discipline and a minimum of fifteen years of related experience; or,

• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Experience in the Biotech/Pharmaceutical industry is required.

• Nine to eleven years of regulatory/medical/technical writing or equivalent writing experience in the pharmaceutical industry, including experience supervising less experienced writers.

• Experience and significant participation in the preparation of complex documents for regulatory submissions (e.g., IND/NDA/BLA/MAA).

• Experience and use of electronic literature tools to obtain reprints of scientific and medical publications.

• Professional certification (eg, AMWA, BELS) is beneficial.

Knowledge/Skills:

• Familiarity with the therapeutic area of oncology is essential.

• Advanced skills in researching, writing, editing, reviewing, and managing regulatory documents.

• Ability to independently organize, integrate, summarize, and present scientific and clinical data and information from a variety of primary sources in an accurate, clear, concise, consistent manner for a variety of audiences.

• Thorough knowledge of the AMA Manual of Style, ICH guidelines, and Regulatory Affairs.

• Excellent writing ability with strong writing and editorial skills with attention to detail.

• Ability to independently develop high-quality complex documents.

• Familiarity with document management systems is essential.

• Strong interpersonal leadership skills with a focus on developing less experienced talent.

• Ability to lead and supervise the work of others and to provide direction to subordinates, peers, or teams based on general policies and management guidance.

• Directs a variety of complicated tasks with a wide degree of independence, creativity, and latitude.

• Identifies and implements methods and procedures