Associate Director/Director, Medical Writing

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

We think differently, act boldly, and push boundaries in pursuit of new heights. We're building a team of scientists and drug developers committed to translating the field of upregulation into transformative medicines.

The journey is exhilarating. The view from the top is breathtaking. Join us at the forefront.

Mission

Pioneering a new approach to upregulate genes

Vision

To change the lives of countless patients with diseases caused by inadequate gene expression

CAMP4 Virtues

Be Bold

Push boundaries and pursue breakthroughs.

Be Agile

Adapt quickly to challenges and opportunities.

Be Curious

Turn curiosity into trailblazing science.

Be Inclusive

Lead with empathy and embrace diverse perspectives.

Act urgently. Patients are waiting.

Open Positions

If you want to be part of a company that is growing, nimble, and intent on changing the world, join the adventure that is CAMP4!

CAMP4 values the strength that diversity brings to the workplace. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.

Position:Associate Director/Director, Medical Writing

Location: Cambridge, MA

Job Id:313

# of Openings:1

Position Title:Associate Director/Director, Medical Writing
Reports To:Vice President, Regulatory Affairs
Location:Watertown, MA

Join the adventure!

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.

Key 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.

Qualifications: Education & Experience

• 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.