Senior Regulatory Medical Writer, Client-embedded, FSP

ThermoFisher Scientific is hiring a Senior Regulatory Medical Writer for a full-time, client-embedded position based in Framingham, Middlesex County. You'll work directly with our pharmaceutical and life sciences clients, developing and managing regulatory documentation that drives compliance and clinical communication strategies.

About the Role

This client-embedded, full-service provider role places you within a client organization where you'll take the lead on regulatory and clinical writing initiatives. Working standard office hours Monday through Friday from our Framingham location, you'll partner closely with client teams to understand their most critical documentation needs and deliver high-quality, compliant content on schedule.

What You'll Do

• Develop and manage regulatory submissions, clinical study reports, and compliance documentation
• Create clear, scientifically accurate medical writing that meets FDA and regulatory requirements
• Work embedded within client teams to understand project requirements and ensure deliverable alignment
• Manage document workflows, version control, and timelines across multiple initiatives
• Ensure all written materials comply with ICH guidelines and industry regulatory standards
• Collaborate with regulatory affairs, clinical, and marketing teams across projects
• Provide guidance on medical writing and regulatory communication strategy

What We're Looking For

• Extensive professional experience in regulatory medical writing
• Deep knowledge of FDA regulations and regulatory submission requirements
• Demonstrated success working in client-facing or embedded positions
• Strong scientific and regulatory writing skills with meticulous attention to detail
• Experience authoring clinical study reports, regulatory dossiers, or similar documents
• Ability to balance multiple projects and meet aggressive deadlines
• Proficiency with Microsoft Office and document management platforms
• Bachelor's degree in life sciences, clinical research, pharmacy, or related field, or equivalent professional background

About ThermoFisher Scientific

ThermoFisher Scientific leads innovation in life sciences, diagnostics, and healthcare. Our organization is committed to advancing scientific discovery and delivering solutions that positively impact health, safety, and environmental sustainability worldwide.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.