What are the responsibilities and job description for the Senior Clinical Medical Writer position at Advantage Technical?
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
Are you ready to try something new? Click 'Apply Now' to submit your resume and connect with a recruiter!
The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.
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About UsAdvantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.
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