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 alignment and achievement of common objectives. Engages internal and external stakeholders to establish productive collaborative relationships.

• Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analyzing, and applying key information to solve problems. Provides regulatory writing expertise to cross-functional teams. Understands the longer-term consequences of decisions and actions.

• Acts with integrity to build trust and execute on team objectives that contribute to departmental goals.

• Capable of proactively assessing workload, trends, tasks, and priorities for the area of responsibility.

• Plans and executes multiple activities.

• Considers alternative methods and contingency plans to avoid potential issues.

• Designs and implements solutions to address project-level challenges, taking into consideration the broader impact.

• Environment: primarily working indoors.

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

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.