CAMP4 Therapeutics
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Pay found in job post Retrieved from the description.
Base pay range $120,000.00/yr - $228,000.00/yr
Position Title:
Senior Medical Writer
Location:
Cambridge, MA
Reports To : Vice President, Regulatory Affairs
Join the Adventure!
We are seeking a highly skilled, detailed-oriented, scientifically driven Medical Writing professional to join our growing biotech team as a Senior Medical Writer. 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 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 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, 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 regulatory 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
Mentor and/or manage junior medical writers or contractors.
Qualifications
Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field.
Minimum of 4‑6 years of medical writing experience in the biotech/pharmaceutical industry.
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.
Preferred Qualifications
Experience in rare disease or neurology therapeutic areas.
Prior involvement in NDA/BLA 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 $120,000 - $228,000. 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.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Marketing, Public Relations, and Writing/Editing
Referrals increase your chances of interviewing at CAMP4 Therapeutics by 2x
Get notified about new Senior Medical Writer jobs in
Cambridge, MA .
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Get AI-powered advice on this job and more exclusive features.
Pay found in job post Retrieved from the description.
Base pay range $120,000.00/yr - $228,000.00/yr
Position Title:
Senior Medical Writer
Location:
Cambridge, MA
Reports To : Vice President, Regulatory Affairs
Join the Adventure!
We are seeking a highly skilled, detailed-oriented, scientifically driven Medical Writing professional to join our growing biotech team as a Senior Medical Writer. 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 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 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, 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 regulatory 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
Mentor and/or manage junior medical writers or contractors.
Qualifications
Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field.
Minimum of 4‑6 years of medical writing experience in the biotech/pharmaceutical industry.
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.
Preferred Qualifications
Experience in rare disease or neurology therapeutic areas.
Prior involvement in NDA/BLA 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 $120,000 - $228,000. 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.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Marketing, Public Relations, and Writing/Editing
Referrals increase your chances of interviewing at CAMP4 Therapeutics by 2x
Get notified about new Senior Medical Writer jobs in
Cambridge, MA .
#J-18808-Ljbffr