Senior Medical Writer – Medical Device, Regulatory Documents

November 19

🦞 Maine – Remote

Although this job is listed in Maine, this company may be open to hiring remote in other states.

🦬 Montana – Remote

Although this job is listed in Montana, this company may be open to hiring remote in other states.

+3 more states

🦞 Maine – Remote 🦬 Montana – Remote 🌲 North Carolina – Remote ⚓ Rhode Island – Remote ☕ Washington – Remote

💵 $80.6k - $145k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

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Syneos Health

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• Leads the clear and accurate completion of medical writing deliverables • Manages medical writing activities associated with individual studies • Completes documents that may include clinical study protocols, clinical study reports, and informed consents • Adheres to established regulatory standards and company procedures • Coordinates quality and editorial reviews • Acts as peer reviewer for internal team • Provides feedback to define statistical output required • Performs online clinical literature searches • Mentor and lead less experienced medical writers

🎯 Requirements

• Leads the clear and accurate completion of medical writing deliverables • Manages medical writing activities associated with individual studies • Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments • Adheres to established regulatory standards, including ICH E3 guidelines • Coordinates quality and editorial reviews • Reviews statistical analysis plans and table/figure/listing specifications • Interacts and builds good working relations with clients, department head, and peers in data management • Mentors and leads less experienced medical writers

🏖️ Benefits

• Health benefits to include Medical, Dental and Vision • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) and sick time