Lead Medical Writer

4 days ago

Cambridge, United States Acumen Medical Communications Full time

Position: (Contract) Lead Nonclinical WriterReports to: Senior Director of Nonclinical WritingLocation: Remote (US) Acumen Medical Communications is a distinguished technology and services firm empowering companies in pharmaceutical development. Clients choose us not because were the largest or least expensive option, but because the quality of our work sets us apart. They trust us to get it right the first time, and we pride ourselves on accuracy, thoroughness, and a level of polish that ensures every project meets the highest standards. To deliver on this commitment, we place a strong emphasis on attracting top talent and compensating them accordingly. Acumen is seeking an experienced Lead Nonclinical Writer to support our clients on a project-by-project basis, contributing to the development of INDs and nonclinical components of NDAs/BLAs. In this role, you will work closely with Acumen writers, program managers, editors, and publishers, to provide high-quality support to client submission teams. Experience in scientific document development required, and familiarity with eCTD Modules 2 and 4 is strongly preferred. Candidates should hold a PhD in a relevant scientific discipline, or an MS with significant industry experience. Experience in cancer biology or immunology a plus.  Responsibilities:       Leads writing for Module 2 nonclinical summaries (M2.2.2-M2.2.7)      Leads writing for Module 4 nonclinical study reports      Works with Acumens or client eCTD templates to ensure accurate formatting and compliance      Partner with clients subject matter experts (SMEs) to define core content, key messaging of assigned documents, and scientific positioning      Draft all versions of assigned documents, including managing comment reconciliation and chairing roundtable review discussions      Develop, maintain, and communicate assigned document timelines      Apply working knowledge of relevant regulatory guidelines (ICH, GCP, and FDA) and prior IND experience to produce scientifically accurate, compliant, and submission-ready documents Requirements:        PhD in a relevant scientific discipline or MS with substantial nonclinical/regulatory writing experience      Demonstrated experience developing scientific or regulatory documents, ideally for INDs, NDAs, or BLAs      Experience contributing to eCTD Modules 2 and/or 4 highly preferred      Background in cancer biology or immunology is advantageous      Strong understanding of nonclinical study design and data interpretation      Familiarity with regulatory guidance including ICH, GCP, and relevant FDA standards      Ability to work within structured templates and document management systems      Proficiency in summarizing complex scientific data into clear, concise, and compliant narratives recblid ljpv1au4afs3z1pup23brxbhyjwxnx

  • Lead Medical Writer

    2 days ago

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    Position: (Contract) Lead Nonclinical WriterReports to: Senior Director of Nonclinical WritingLocation: Remote (US) Acumen Medical Communications is a distinguished technology and services firm empowering companies in pharmaceutical development. Clients choose us not because were the largest or least expensive option, but because the quality of our work...

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