Assoc Scientific Regulatory Writing Director

SUMMARY/JOB PURPOSE (Basic purpose of the job):

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 crossfunctional 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 intext 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.

• May mentor less experienced writers.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

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

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

• PhD in related discipline and a minimum of five 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 preferred.

• Prior regulatory/medical/technical writing experience within the biotech, pharmaceutical, or CRO industry.

• 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 therapeutic area of oncology.

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

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

Knowledge, Skills and Abilities:

• Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results. Takes pride in delivering high quality work.

• Applies wide knowledge of the regulatory framework and industry practices to develop innovative approaches and complete 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 groups of departmental colleagues.

• Strong interpersonal skills and ability to accommodate differing views to actively support the development of an agreed upon resolution.

• Manages effectively performing teams to achieve common objectives. Engages internal stakeholders to establish productive collaborative relationships.

• Applies knowledge of organizational goals and objectives and demonstrates skill and insight in gathering, analyzing and applying key information to solve problems.

• Leads self and others; acts with integrity and builds trust with colleagues to contribute to accomplishing team objectives.

• Capable of managing the execution of multiple tasks.

• Ensures appropriate prioritization and execution for area of responsibility.

• Proactively anticipates, prioritizes and resolves task-related challenges.

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

Work Environment/Physical Demands:

• Environment: primarily working indoors.

• Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.

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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.