Senior Principal Regulatory Medical Writer – Oncology Preferred

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Create regulatory documents for submission to global regulatory agencies.

• Oversee medical writing projects, ensuring adherence to timelines and effective communication.

• Engage in cross-functional meetings to contribute insights on deliverables.

• Evaluate related documents for assigned projects as necessary.

⛳️ Requirements

• Proven experience in medical writing for submissions to regulatory agencies worldwide.

• Comprehensive knowledge of ICH and other international guidelines.

• Preferred experience with eCTD submissions.

• Capability to manage medical writing projects, including timelines and communication efforts.

• Skills in collaborating within cross-functional teams.

🏝️ Benefits

• Health benefits that encompass Medical, Dental, and Vision coverage.

• 401k plan with company matching.

• Opportunity to participate in the Employee Stock Purchase Plan.

• Potential to earn commissions or bonuses based on both company and individual performance.

• Flexible paid time off (PTO) along with sick time.

• Provision of a company car or a car allowance.