Associate Director/Director, Medical Writing

Camp 4 Ranch•Cambridge, MA

13h•$185,000 - $260,000•Onsite

About The Position

CAMP4 Therapeutics is seeking a scientifically-driven, highly skilled, detailed-oriented Medical Writing professional to join our growing biotech team as an Associate Director or Director, Medical Writing. This role is responsible for the development of high-quality clinical and regulatory documents and scientific publications. The ideal candidate will bring deep expertise in medical writing, strong leadership capabilities, and a collaborative mindset to help drive our pipeline forward.

Requirements

Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field.
Minimum of 8 years of medical writing experience in the biotech/pharmaceutical industry, with at least 2 years in a leadership role.
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.
Experience in rare disease, neurology, or other relevant therapeutic areas.
Prior involvement in NDA/BLA/MAA submissions.
Familiarity with EMA and other ex-US regulatory requirements.

Responsibilities

Lead the planning, writing, and review of clinical and regulatory documents including: Clinical study protocols and amendments, Investigator’s 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, Clinical Operations, 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 ICH 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
Manage junior medical writers and/or contractors.