Senior Director, Scientific Regulatory Writing

SUMMARY/JOB PURPOSE:

Asset lead. Expert at content development for the asset, including knowledge of current developments and wellinformed 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 crossfunctional 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 crossfunctional 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 assetrelated content. May indirectly supervise employees through a dottedline 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 to achieve results.

• Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.

• Has complete understanding and wide application of technical principles, theories, concepts, and techniques.

• Has good general knowledge of other related disciplines.

• Has good timeline development and management skills.

• Applies strong analytical and business communication skills.

JOB COMPLEXITY:

• Supervision of multiple less experienced writers, emphasizing collaboration, skill development, and career growth.

• Works on significant and unique issues where analysis of situations requires an evaluation of intangibles. A high level of independent work is required.

• Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation of criteria for obtaining results.

• Uses professional concepts and the company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways and is answerable to group and team leadership.

• Networks with key contacts outside their area of expertise.

WORKING CONDITIONS:

• Environment: primarily working indoors, performing clerical work.

Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Exelixis, Inc. through this page. We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department. Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.

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