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Senior Medical Writer Job at CAMP4 Therapeutics in Cambridge
Senior Medical Writer Job at CAMP4 Therapeutics in CambridgeMediabistro • Cambridge, MA, United States
Senior Medical Writer Job at CAMP4 Therapeutics in Cambridge

Senior Medical Writer Job at CAMP4 Therapeutics in Cambridge

Mediabistro • Cambridge, MA, United States
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Join to apply for the Senior Medical Writer role at CAMP4 Therapeutics .

Position Title : Senior Medical Writer

Location : Cambridge, MA

Reports To : Vice President, Regulatory Affairs

Key Responsibilities

  • Lead the planning, writing, and review of clinical and regulatory documents, including clinical study protocols and amendments, investigator brochures (IBs), INDs, NDAs, safety narratives, and annual reports.
  • Develop and write scientific content for peer‑reviewed manuscripts, congress abstracts, posters, and slide decks.
  • Collaborate cross‑functionally with Clinical Development, Regulatory Affairs, Biostatistics, Preclinical / Research, and CMC to ensure alignment and accuracy of scientific content.
  • Develop and maintain document templates and style guides in accordance with regulatory and company standards.
  • Manage timelines and deliverables across multiple projects, ensuring high‑quality output under tight deadlines.
  • Provide strategic input on document content and regulatory strategy.
  • Maintain up‑to‑date knowledge of therapeutic area(s), product(s), and relevant literature.
  • Mentor and / or manage junior medical writers or contractors.

Qualifications

  • Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field.
  • Minimum of 4-6 years of medical writing experience in the biotech / pharmaceutical industry.
  • Proven track record of authoring and managing regulatory documents for global submissions and scientific documents in peer‑reviewed journals.
  • Strong understanding of clinical research, data interpretation, and regulatory standards.
  • Deep understanding of ICH guidelines, GCP, and regulatory requirements.
  • Exceptional writing, editing, and communication skills.
  • Ability to work independently and collaboratively in a fast‑paced environment.

    • Preferred Qualifications

  • Experience in rare disease or neurology therapeutic areas.
  • Prior involvement in NDA / BLA submissions.
  • Familiarity with EMA and other ex‑US regulatory requirements.

    • About CAMP4

    CAMP4 is developing disease‑modifying treatments for a broad range of genetic diseases where amplifying healthy protein may offer therapeutic benefits. Our approach amplifies mRNA by harnessing a fundamental mechanism of how genes are controlled. To amplify mRNA, our therapeutic ASO drug candidates target regulatory RNAs (regRNAs), which act locally on transcription factors and are the master regulators of gene expression. CAMP4’s proprietary RAPTM Platform enables the mapping of regRNAs and design of optimal chemistry to generate potent therapeutic candidates to address hundreds of genetic diseases across multiple tissues. Learn more about us at www.camp4tx.com and follow us @CAMP4tx.

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    Senior Medical Writer • Cambridge, MA, United States