What are the responsibilities and job description for the Associate Director/Director, Medical Writing position at CAMP4 Therapeutics?
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:
Education & Experience
At CAMP4 Therapeutics, we offer a competitive and thoughtfully designed total rewards program. The anticipated salary range for this role is $185,000 - $260,000. 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.
About CAMP4:
CAMP4 is developing disease-modifying treatments for a broad range of genetic diseases where amplifying healthy protein may offer therapeutic benefits. Our approach amplifies mRNA by harnessing a fundamental mechanism of how genes are controlled. To amplify mRNA, our therapeutic ASO drug candidates target regulatory RNAs (regRNAs), which act locally on transcription factors and are the master regulators of gene expression. CAMP4’s proprietary RAPTM Platform enables the mapping of regRNAs and design of optimal chemistry to generate potent therapeutic candidates to address hundreds of genetic diseases across multiple tissues. Learn more about us at www.camp4tx.com and follow us @CAMP4tx.
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.
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.
- 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.
At CAMP4 Therapeutics, we offer a competitive and thoughtfully designed total rewards program. The anticipated salary range for this role is $185,000 - $260,000. 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.
About CAMP4:
CAMP4 is developing disease-modifying treatments for a broad range of genetic diseases where amplifying healthy protein may offer therapeutic benefits. Our approach amplifies mRNA by harnessing a fundamental mechanism of how genes are controlled. To amplify mRNA, our therapeutic ASO drug candidates target regulatory RNAs (regRNAs), which act locally on transcription factors and are the master regulators of gene expression. CAMP4’s proprietary RAPTM Platform enables the mapping of regRNAs and design of optimal chemistry to generate potent therapeutic candidates to address hundreds of genetic diseases across multiple tissues. Learn more about us at www.camp4tx.com and follow us @CAMP4tx.
Salary : $185,000 - $260,000