Lead CMC Writer - Contract

Overview

Acumen is seeking an experienced lead CMC writer to join our team on a project-by-project basis to support Acumen’s clients in writing and submitting INDs and nonclinical portions of NDAs/BLAs. The CMC Writer will work alongside other Acumen writers, program managers, editors, and publishers, to provide complete support to client submission teams. Previous experience contributing to the CMC eCTD Modules 2 & 3 is required. Candidates should an advanced degree in a relevant scientific discipline with strong industry experience. Experience with biologics a plus.

Compensation is very competitive.

Core responsibilities

• Leads writing for CMC portions of Module 2 and Module 3

• Works with Acumen’s or client eCTD templates

• Collaborates with client’s subject matter experts (SMEs) to determine core content and key messaging of assigned documents

• Writes all drafts of assigned documents, including comment reconciliation and chairing any required round tables

• Develops and maintains assigned document timelines

• Applies working knowledge of key regulatory guidelines, such as ICH, GCP, and FDA guidance, and previous IND/NDA/BLA experience to assist submission teams to generate compliant, scientifically accurate, and well written documents for submission

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