Associate 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.

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 in-text tables.
• Sets 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.