Lead Clinical Regulatory Writer -Contract

Role

Acumen is seeking an experienced lead clinical writer to join our team on a steady project-by-project basis to support Acumen’s clients in writing and submitting various regulatory documents. Workload would be flexible with up to 25-30 hours a week. Projects could include protocols, amendments, investigator’s brochure updates, DSURs, briefing books, CSRs, and NDA/BLA summaries. The Lead Clinical Writer will work alongside other Acumen writers, program managers, editors, and publishers, to provide complete support to client teams. The writer will also work directly with client/sponsor teams. Previous clinical document development required, and experience contributing to eCTD Modules 2 & 5 preferred. Candidates should have a strong background in industry and/or CRO writing. Experience in oncology or immunology therapeutic areas a plus. This is a remote contract opportunity with occasional local on-site client meetings possible (conditions permitting).

Compensation is extremely competitive.

Core responsibilities

• Leads writing stand-alone regulatory documents

• Leads or contributes to Module 2 summaries (M2.5, M2.7.3, M2.7.4)

• Leads writing for Module 5 clinical study reports and integrated summaries

• Interfaces with client team to manage document through all stages of development

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

Interested? Contact us HERE