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.

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:

• No direct reports.

• Supervises work of junior writers and regulatory editors on document tasks.

• May direct and review the work of contract writers as needed.

• Mentors less experienced writers.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

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

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

• PhD in related discipline and a minimum of eight 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:

• Experience in Biotech/Pharmaceutical industry is required.

• A minimum of seven 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 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 the therapeutic area of oncology is essential.

• Advanced knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidelines, and GCP standards.

• Advanced knowledge of AMA style, medical terminology, and clinical data analysis.

• Professional certification (e.g., AMWA, BELS) is beneficial.

Knowledge, Skills and Abilities:

• Develops and manages plans, establishes timelines, and sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high-quality work.

• Applies extensive knowledge of the regulatory framework, industry drivers, and practices to develop innovative approaches and manage complex work.

• Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to cross-functional groups of colleagues.

• Strong interpersonal skills and ability to accommodate differing views to influence an agreed-upon resolution.

• Facilitates team alignmen