Senior Principal Medical Writer – Regulatory, Oncology

October 3

🌵 Arizona – Remote

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

🦞 Maine – Remote

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

+3 more states

🌵 Arizona – Remote 🦞 Maine – Remote 🌲 North Carolina – Remote 🏈 Ohio – Remote ⚓ Rhode Island – Remote

💵 $114k - $210.9k / 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

• Develop regulatory documents for submission to regulatory agencies globally • Manage medical writing projects, including developing timelines and communication with cross-functional team members • Participate in cross-functional meetings to provide input regarding medical writing deliverables • Review other documents associated with the assigned project(s) • Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents • Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects • Mentor more junior medical writing staff

🎯 Requirements

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes • Manage medical writing projects, including developing timelines and communication with cross-functional team members • Participate in cross-functional meetings to provide input regarding medical writing deliverables • Review other documents associated with the assigned project(s) • Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents • Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects • Mentor more junior medical writing staff

🏖️ 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