Director, Medical Writing — Lead Regulatory & Publications

CAMP4 Therapeutics; Cambridge (MA); On-site; USD 177,000 - 240,000; Full time

Benefits offered by this job

Annual bonus

Equity incentive

Medical/dental/vision

401(k) with company contribution

Employee Stock Purchase Program

Trek Time

Tuition assistance

Parental leave

Job summary

CAMP4 Therapeutics in Watertown, MA is seeking an Associate Director or Director of Medical Writing to lead creation and review of clinical and regulatory documents, and guide regulatory strategy. The role also involves mentoring junior writers and collaborating across cross-functional teams.

The ideal candidate brings an advanced life sciences degree, 8+ years in medical writing with leadership, and a track record in NDA/BLA submissions, ICH/GCP compliance, and strategic content development.

Qualifications

• Advanced degree in life sciences or related field.
• 8+ years medical writing experience in biotech/pharma.
• At least 2 years in a leadership role.

Responsibilities

• Lead planning, writing, and review of clinical and regulatory documents (protocols, IBs, INDs, NDAs, safety narratives).
• Develop scientific content for manuscripts, abstracts, posters, and slides.
• Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, and other teams.
• Maintain templates and style guides per ICH and company standards.
• Manage timelines and deliverables across multiple projects.
• Provide strategic input on content and regulatory strategy.
• Mentor junior medical writers/contractors.

Skills

Regulatory writing

Clinical research

ICH/GCP knowledge

Editing & writing

Independent work

Rare diseases

NDA/BLA submissions

Regulatory strategy

Education

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

Job description

CAMP4 Therapeutics in Watertown, MA is seeking an Associate Director or Director of Medical Writing to lead creation and review of clinical and regulatory documents, and guide regulatory strategy. The role also involves mentoring junior writers and collaborating across cross-functional teams.

The ideal candidate brings an advanced life sciences degree, 8+ years in medical writing with leadership, and a track record in NDA/BLA submissions, ICH/GCP compliance, and strategic content development.