📌 Core Information
🔹 Job Title: Clinical Research Writer
🔹 Company: Axogen
🔹 Location: Tampa, Florida, United States
🔹 Job Type: On-site
🔹 Category: Biotechnology Research
🔹 Date Posted: 2025-04-07
🔹 Experience Level: 5-10 years
🔹 Remote Status: On-site
🚀 Job Overview
Key aspects of this role include:
- Developing clear, accurate, and scientifically rigorous documents for regulatory submissions and clinical studies.
- Collaborating with cross-functional teams to align messaging across scientific and commercial content.
- Ensuring compliance with regulatory guidelines, GCP, and ICH standards.
- Managing multiple projects simultaneously while maintaining high quality and meeting deadlines.
ASSUMPTION: This role requires a strong background in clinical research, regulatory submissions, and scientific publications, with a focus on preparing regulatory and scientific content in compliance with industry standards and regulatory requirements.
📋 Key Responsibilities
✅ 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 stakeholders to ensure the scientific integrity and clarity of documents. Managing multiple projects simultaneously while maintaining high quality and meeting deadlines.
✅ Compliance & Documentation: Ensuring all documents comply with GCP (Good Clinical Practice), ICH (International Council for Harmonisation), and FDA standards. Supporting Standard Operating Procedure (SOP) development and document control processes. Performing other duties as assigned by the supervisor.
ASSUMPTION: The specific duties of the Clinical Research Writer may evolve based on the company's needs and the individual's skills and experiences.
🎯 Required Qualifications
Education: Advanced degree (MS, Ph.D., PharmD, MD) in life sciences, clinical research, biomedical engineering or a related field.
Experience: Minimum 5 years of experience in clinical research in the biotech or medical device industry, including experience in leading clinical trials.
Required Skills:
- Strong background in clinical research, regulatory submissions, and scientific publications.
- Experience with FDA submissions, including INDs, BLAs, PMAs, and/or 510(k)s.
- Excellent written and verbal communication skills, including the ability to present complex clinical data to both scientific and non-scientific audiences.
- Strong leadership skills with the ability to work in cross-functional teams.
Preferred Skills:
- Experience with specific regulatory guidelines and submission processes for medical devices and biologics.
- Familiarity with GCP, ICH, and other relevant standards and regulations.
ASSUMPTION: Candidates with additional relevant experience or certifications may be preferred but are not strictly required.
💰 Compensation & Benefits
Salary Range: $110,585 - $138,231 USD per year
Benefits:
- Health, Dental, Vision insurance
- Matching 401K
- Paid Time Off and Holidays
- Dependent Care and Medical Flexible Spending Accounts
- Tuition Reimbursement
- Paid Parental and Caregiver Leave
- Life and Disability Insurance
- Employee Stock Purchase Plan
Working Hours: Full-time, typically 40 hours per week, with flexibility for project demands.
ASSUMPTION: The salary range provided is based on industry standards for similar roles and may vary depending on the candidate's experience and qualifications.
📌 Applicant Insights
🔍 Company Context
Industry: Axogen is a leading company focused on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. They are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or discontinuity to peripheral nerves.
Company Size: Axogen has 201-500 employees, providing a mid-sized company environment with opportunities for growth and collaboration.
Founded: Axogen was founded in 2002 and is headquartered in Alachua, Florida, with additional locations in Tampa, Florida; Burleson, Texas; Dayton, Ohio; and Vandalia, Ohio.
Company Description:
- Axogen's comprehensive portfolio of products focuses on helping patients touch, run, feel, kiss, smile, and hug—some of the many things healthy peripheral nerves allow us to do.
- The company's mission is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care.
- Axogen aims to lead the markets they serve by always requiring the solutions they offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care.
Company Specialties:
- Medical Device
- Peripheral Nerve Repair
- Biotechnology
- Tissue Engineering
- Regenerative Medicine
- Translational Science
- Processed Nerve Allograft
- Biologics
- Life Science
Company Website: https://www.axogeninc.com
ASSUMPTION: Axogen's focus on peripheral nerve repair and regeneration makes it an attractive option for candidates interested in making a significant impact on patients' lives.
📊 Role Analysis
Career Level: The Clinical Research Writer role is a mid-level position that requires a strong background in clinical research and regulatory submissions. This role offers opportunities for growth and advancement within the company.
Reporting Structure: The Clinical Research Writer will report directly to the Manager of Clinical Research and will collaborate with various cross-functional teams, including Clinical, R&D, Regulatory, and Marketing.
Work Arrangement: This is an on-site position, with the primary work location being Axogen's Tampa, Florida office. Some flexibility may be available for remote work, depending on the candidate's needs and the company's current policies.
Growth Opportunities:
- As Axogen continues to grow and expand its product portfolio, there may be opportunities for the Clinical Research Writer to take on additional responsibilities or move into a management role.
- The company's focus on innovation and cutting-edge research provides ample opportunities for professional development and growth.
- Axogen's commitment to employee education and training offers various growth opportunities, including tuition reimbursement and internal training programs.
ASSUMPTION: The Clinical Research Writer role offers a unique opportunity to work at the intersection of science, regulation, and patient care, providing a strong foundation for a successful career in the biotechnology industry.
🌍 Location & Work Environment
Office Type: Axogen's Tampa office is a modern, collaborative workspace that fosters innovation and creativity. The company encourages a casual dress code and provides a relaxed, comfortable work environment.
Office Location(s): 111 West Oak Avenue, Tampa, Florida 33602
Geographic Context:
- Tampa, Florida, is a vibrant, growing city with a diverse economy and a strong job market.
- The Tampa Bay area is home to a thriving biotechnology and healthcare industry, providing ample opportunities for professional networking and growth.
- Tampa offers a variety of cultural attractions, recreational activities, and a high quality of life, making it an attractive place to live and work.
Work Schedule: The Clinical Research Writer position follows a standard full-time work schedule, with core hours typically between 8:00 AM and 5:00 PM, Monday through Friday. Some flexibility may be available for alternative work arrangements, depending on the candidate's needs and the company's current policies.
ASSUMPTION: Axogen's Tampa office provides a dynamic, engaging work environment that supports the company's mission and values.
💼 Interview & Application Insights
Typical Process:
- Online application submission through Axogen's careers portal
- Phone or video screen with the Hiring Manager
- On-site or virtual interview with a panel of interviewers, including representatives from Clinical, R&D, and Regulatory teams
- Final interview with the Vice President of Clinical Research
- Job offer and onboarding
Key Assessment Areas:
- Clinical research and regulatory submission experience
- Writing and communication skills
- Collaboration and teamwork abilities
- Problem-solving and project management skills
- Alignment with Axogen's mission, values, and company culture
Application Tips:
- Tailor your resume and cover letter to highlight your relevant clinical research, regulatory submission, and scientific writing experience.
- Be prepared to discuss specific examples of your work, including regulatory submissions, scientific publications, and cross-functional collaborations.
- Research Axogen's mission, values, and company culture to demonstrate your fit and enthusiasm for the role.
ATS Keywords: Clinical Research, Regulatory Submissions, Scientific Writing, FDA Submissions, Biologics, Medical Devices, GCP, ICH, Cross-Functional Collaboration, Project Management
ASSUMPTION: Axogen's interview process is designed to assess the candidate's technical skills, cultural fit, and alignment with the company's mission and values.
🛠️ Tools & Technologies
- Microsoft Office Suite (Word, Excel, PowerPoint)
- Regulatory submission software (e.g., eCTD, Veeva Vault)
- Scientific writing and publishing software (e.g., EndNote, Mendeley)
- Project management tools (e.g., Asana, Trello)
ASSUMPTION: The Clinical Research Writer will be expected to use various tools and technologies to manage projects, collaborate with teams, and ensure compliance with regulatory guidelines.
👔 Cultural Fit Considerations
Company Values:
- Patient-focused
- Innovative
- Collaborative
- Accountable
- Committed to excellence
Work Style:
- Dynamic and fast-paced
- Team-oriented and collaborative
- Focused on results and continuous improvement
- Adaptable and open to change
Self-Assessment Questions:
- How do you ensure that your writing aligns with Axogen's patient-focused mission and values?
- Describe your experience working in a dynamic, fast-paced environment and how you adapt to change.
- How do you approach collaborating with cross-functional teams to ensure clear, concise, and scientifically rigorous communication?
ASSUMPTION: Axogen's company culture emphasizes innovation, collaboration, and a commitment to excellence, making it an attractive option for candidates who thrive in dynamic, team-oriented environments.
⚠️ Potential Challenges
- Managing multiple projects simultaneously while maintaining high quality and meeting deadlines may be challenging for some candidates.
- Working in a fast-paced, dynamic environment may require adaptability and flexibility.
- Ensuring compliance with regulatory guidelines, GCP, and ICH standards may be complex and time-consuming.
- The Tampa, Florida, office may not be suitable for candidates who prefer a more laid-back or remote work environment.
ASSUMPTION: The Clinical Research Writer role offers a unique opportunity to work at the intersection of science, regulation, and patient care, but it also presents specific challenges that candidates should be prepared to address.
📈 Similar Roles Comparison
- The Clinical Research Writer role at Axogen differs from similar roles at other biotechnology or medical device companies in its focus on peripheral nerve regeneration and repair. This unique focus provides an opportunity to work on cutting-edge research and make a significant impact on patients' lives.
- Biotechnology and medical device industries vary in their regulatory requirements, submission processes, and compliance standards. Axogen's focus on peripheral nerve repair and regeneration may require specific knowledge and experience in this area.
- Career paths in clinical research and regulatory affairs may vary depending on the company's size, structure, and specific needs. Axogen's mid-sized company environment offers opportunities for growth and advancement within the company.
ASSUMPTION: The Clinical Research Writer role at Axogen offers a unique combination of challenges, opportunities, and rewards that set it apart from similar roles in the biotechnology and medical device industries.
📝 Sample Projects
- Developing a comprehensive regulatory submission for a novel biologic product for peripheral nerve repair, including drafting and editing clinical study reports, investigator brochures, and regulatory documents.
- Preparing a peer-reviewed manuscript and conference abstract based on a pre-clinical study of a new medical device for peripheral nerve repair, including conducting a comprehensive literature review and collaborating with cross-functional teams to ensure scientific integrity and clarity.
- Supporting a grant application for a research collaboration focused on peripheral nerve regeneration, including drafting the research plan, budget justification, and other required documents, and ensuring compliance with NIH and industry funding requirements.
ASSUMPTION: The specific projects that the Clinical Research Writer will work on at Axogen will depend on the company's current research and development priorities, as well as the individual's skills and experiences.
❓ Key Questions to Ask During Interview
- Can you describe the typical timeline and milestones for a regulatory submission at Axogen?
- How does Axogen support collaboration and communication between cross-functional teams, particularly in the context of regulatory submissions and scientific publications?
- What opportunities are available for professional development and growth within the Clinical Research Writer role and the company as a whole?
- How does Axogen ensure compliance with regulatory guidelines, GCP, and ICH standards, and what resources are available to support this process?
- What is the typical work-life balance for a Clinical Research Writer at Axogen, and how does the company support work-life balance for its employees?
ASSUMPTION: Asking thoughtful, informed questions during the interview process demonstrates your interest in the role and commitment to understanding Axogen's unique culture and priorities.
📌 Next Steps for Applicants
To apply for this position:
- Submit your application through this link
- Tailor your resume and cover letter to highlight your relevant clinical research, regulatory submission, and scientific writing experience.
- Prepare for the interview by researching Axogen's mission, values, and company culture, and be ready to discuss specific examples of your work.
- If selected for a final interview, be prepared to present a sample of your writing and discuss your approach to regulatory submissions, scientific publications, and cross-functional collaboration.
- Follow up with the Hiring Manager within 24 hours after your interview to express your appreciation and reiterate your interest in the role.
⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.
