Clinical Research Writer

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!  

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. 

 Why you’ll love working at Axogen: 

• Friendly, open, and fun team culture that values unique perspectives 
• Company-wide dedication to profoundly impacting patients’ lives 
• Comprehensive, high-quality benefits package effective on date of hire 
• Educational assistance available for all employees 
• Matching 401(k) retirement plan 
• Paid holidays, including floating holidays, to be used at your discretion 
• Employee Stock Purchase Plan 
• Referral incentive program 

If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: https://www.axogeninc.com/patient-stories/ 

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Clinical Research Writer

The Clinical Research Writer will be responsible for developing clear, accurate, and scientifically rigorous documents that support regulatory submissions, clinical studies, scientific publications, and internal communications. The role requires expertise in biotech, medical devices, and biologic products, with a focus on preparing regulatory and scientific content in compliance with industry standards and regulatory requirements.

Requirements of the Clinical Research Writer

• Advanced degree (MS, Ph.D., PharmD, MD) in life sciences, clinical research, biomedical engineering or a related field.
• Minimum 5 years of experience in clinical research in the biotech or medical device industry, including experience in leading clinical trials.
• Strong background in clinical research, regulatory submissions, and scientific publications.
• Experience with FDA submissions, including INDs, BLAs, PMAs, and/or 510(k)s.
• Strong leadership skills with the ability to work in cross-functional teams.
• Excellent written and verbal communication skills, including the ability to present complex clinical data to both scientific and non-scientific audiences.

Responsibilities of the Clinical Research Writer

The specific duties of the Clinical Research Writer include but are not limited to:

• Regulatory Writing:
• Drafting, reviewing, and editing clinical study reports (CSRs), investigator brochures (IBs), protocols, informed consent forms, and regulatory documents for Biologics License Applications (BLA), Investigational New Drug (IND), Investigational Device Exemption (IDE), and 510(k) submissions.
• Ensuring alignment with FDA and international regulatory guidelines for medical device and biologic product submissions.
• Scientific & Clinical Writing:
• Preparing peer-reviewed manuscripts and conference abstracts based on pre-clinical and clinical studies.
• Developing white papers, literature reviews, and clinical study summaries to support scientific and commercial initiatives.
• Conducting comprehensive literature reviews to support the development of publications and regulatory documents.
• Publication & Grant Support:
• Assisting in the manuscript publication strategy, ensuring timely and high-quality submission to journals.
• Supporting grant applications and funding proposals, including compliance with NIH and industry funding requirements.
• Writing annual grant reports and progress summaries for research collaborations.
• Cross-functional Collaboration:
• Partnering with Clinical, R&D, Regulatory, and Marketing teams to align messaging across scientific and commercial content.
• Collaborating with internal and external sta