Position Title: Associate Director/Director, Medical Writing
Reports To: Vice President, Regulatory Affairs
Location: Watertown, MA
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.
Skills & Competencies
- 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.
Compensation and Benefits:At CAMP4 Therapeutics, we offer a competitive and thoughtfully designed total rewards program. The anticipated salary range for this role is $177,000 - $240,000. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. In addition to base salary, employees are eligible to receive an annual bonus and equity incentive opportunities.
Our benefits include medical, dental, and vision insurance; life and disability coverage; paid parental leave; a 401(k) plan with company contribution; Employee Stock Purchase Program, Trek Time (flexible time off); tuition assistance; and additional perks that support your well-being and professional growth.
