Director, Medical Writing: Regulatory Strategy & Leadership

Camp4 Therapeutics; Cambridge (MA); On-site; USD 170,000 - 210,000; Full time

Job summary

CAMP4 Therapeutics is seeking an Associate Director/Director, Medical Writing to lead the creation of high-quality clinical and regulatory documents. You will oversee planning, writing, and review, mentor junior writers, and partner with cross-functional teams to ensure scientific accuracy and regulatory readiness.

The ideal candidate has a strong background in biotech/pharma medical writing, with leadership experience and excellent communication skills to drive submissions and publications

Qualifications

• 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.

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.

Skills

Leadership

Medical writing

Education

Advanced degree (PhD, PharmD, MD, or MS)

Job description

CAMP4 Therapeutics is seeking an Associate Director/Director, Medical Writing to lead the creation of high-quality clinical and regulatory documents. You will oversee planning, writing, and review, mentor junior writers, and partner with cross-functional teams to ensure scientific accuracy and regulatory readiness.

The ideal candidate has a strong background in biotech/pharma medical writing, with leadership experience and excellent communication skills to drive submissions and publications