Senior Clinical Medical Writer

Senior Clinical Medical Writer - Contract (Remote, Acton, MA)

Rate: Up to $80/hr. | Duration: 6 months | Location: Remote (U.S.-based)

We are seeking an experienced Senior Clinical Medical Writer to create high-quality clinical research documents in compliance with regulatory requirements and Insulet's standard operating procedures. This role supports global markets and encompasses all geographies where Insulet operates.

Key Responsibilities:

• Write submission-level clinical documents, including study protocols, reports, synopses, investigator brochures, clinical evaluation plans (CEP/CER), and post-market clinical follow-up (PMCF) documents.
• Interpret clinical data clearly, accurately, and concisely to meet regulatory and company standards.
• Maintain and manage regulatory documents in collaboration with cross-functional teams.
• Conduct structured literature searches, analyze data, and summarize risks, alternative therapies, and device benefits.
• Ensure consistency, accuracy, and high quality across all issued documents.
• Stay up-to-date on therapeutic areas, competitor devices, and clinical developments.
• Perform additional tasks and support ad hoc clinical writing needs as required.

Qualifications:

• Master's degree in Life Sciences with 3+ years of medical writing experience in medical devices, biotechnology, or CROs OR BS with 5+ years of experience.
• Strong knowledge of worldwide clinical regulations and guidance documents.
• Expertise in Microsoft Word, Excel, and PowerPoint.
• Excellent analytical, communication, and writing skills.
• Strong attention to detail and ability to prioritize multiple tasks in a fast-paced environment.
• Professional interaction across all organizational levels and the ability to escalate issues appropriately.

Travel: Up to 10% (domestic and international)

Employee Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plans
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks
• Health Savings Account (HSA)
• AD & D Insurance

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