Senior Principal Regulatory Medical Writer – Oncology Preferred

🔥 0 minutes ago

🌲 North Carolina – Remote

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💵 $95k - $210.9k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

🦅 H1B Visa Sponsor

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Syneos Health

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

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.

📋 Description

• Develop regulatory documents for submission to regulatory agencies globally • Manage medical writing projects, including timelines and communication • Participate in cross-functional meetings to provide input regarding deliverables • Review other documents associated with assigned projects as appropriate

🎯 Requirements

• Experience with medical writing for submission to regulatory agencies globally • Strong understanding of ICH and other global guidelines • eCTD submission experience preferred • Ability to manage medical writing projects including timelines and communication • Cross-functional team collaboration skills

🏖️ 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 • Company car or car allowance

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