Medical Writer IV

Our client is seeking a Medical Writer IV to join their Regulatory Clinical Evaluation team. As a Medical Writer IV, you will support the technical and strategic writing needs across the product development and life cycle process. The ideal candidate will bring strong clinical evidence evaluation skills, a detail-oriented approach to high-integrity documentation, and the ability to collaborate effectively across cross-functional teams.

Job Title:Medical Writer IV

Location:On site at Santa Clara, CA;
St. Paul, MN;
Maple Grove, MN; or Plano, TX locations, with the possibility of fully remote for qualified candidates who are close to client location to pick up equipment. Remote associates are not eligible to convert to permanent roles; experienced remote contractors may be considered for the contingent role.

Pay Range: $66/hr.

- $71/hr.

Job Title:12+ Month Conract

What's the Job?

• Write and contribute to Clinical Evaluation Reporting deliverables, including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses, and related documentation for Vascular products.
• Evaluate and summarize clinical evidence from sources such as clinical investigations, literature, post-market surveillance, risk, and post-market clinical evaluations; analyze results to support product applications and submissions.
• Collaborate with stakeholders to plan for and support CER-related projects, processes, and deliverables.
• Review and ensure alignment of risk information across IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), PMS Plans, PMCF Plans/Reports, SSCPs, and physician training materials.
• Ensure quality and compliance of all deliverables and documentation, maintaining data integrity and adherence to applicable regulations and Abbott SOPs/DOPs.

What's Needed?

• Bachelor’s Degree or an equivalent combination of education and work experience.
• 6–8 years of medical writing experience in the medical or pharmaceutical industry, or 8+ years of general technical writing experience.
• Experience that may include medical, pharmaceutical, medical device, clinical research, medical/research industry writing, or a combination of these skills.
• Strong written and verbal communication skills, with the ability to work effectively in collaborative, cross-functional teams.
• Proficiency with Word, Excel, PowerPoint, Outlook, and strong analytical skills to manage complex tasks and timelines.

What's in it for me?

• Opportunity to contribute to clinical evaluation reporting for Vascular medical devices across the product life cycle.
• Work on high-impact regulatory documentation that supports submissions and responses to complex stakeholder queries.
• Collaborate with teams across Sales and Marketing, R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Clinical Science, Risk Management, and Medical Affairs.
• Build and apply expertise in clinical evidence evaluation, risk alignment, and regulatory-ready documentation.
• Join a team focused on quality, consistency, and integrity of data in compliance with applicable standards and guidance.

Days/

Hours:

Mon–Friday, daytime hours (40 hours per week). If not in PST, there may be occasional meetings after 5 pm.

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!