Lead Nonclinical Writer - Contract

Overview

Acumen is seeking an experienced lead nonclinical 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 Lead Nonclinical Writer will work alongside other Acumen writers, program managers, editors, and publishers, to provide complete support to client submission teams. Previous scientific document development required, and experience contributing to eCTD Modules 2 & 4 preferred. Candidates should have a PhD in a relevant scientific discipline, or an MS with strong industry experience. Experience in cancer biology or immunology a plus.

Compensation is very competitive.

Core responsibilities

• Leads writing for Module 2 summaries (M2.2.2, M2.2.3,M2.2.4, M2.2.5, M2.2.6, M2.2.7)

• Leads writing for Module 4 nonclinical study reports

• 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 experience to assist submission teams to generate compliant, scientifically accurate, and well written documents for submission

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