Sponsor Dedicated - Senior Regulatory Submissions writer

Syneos Health is seeking a Senior Regulatory Submissions writer to lead the clear and accurate completion of medical writing deliverables. The successful candidate will manage medical writing activities associated with individual studies, coordinate with clients, and adhere to established regulatory standards.

Responsibilities:

• Lead the completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
• Manage medical writing activities associated with individual studies, coordinating with departments and clients
• Complete a variety of documents, including clinical study protocols, clinical study reports, and regulatory submissions
• Adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures
• Coordinate quality and editorial reviews, and ensure source documentation is managed appropriately
• Act as peer reviewer for internal team to ensure document scientific content, clarity, and consistency
• Interact and build good working relations with clients, department head, and peers
• Perform online clinical literature searches and comply with copyright requirements
• Identify and propose solutions to resolve issues, escalating as appropriate
• Mentor and lead less experienced medical writers on complex projects
• Develop deep expertise on key topics in the industry and regulatory requirements
• Manage budget specifications for assigned projects
• Complete required administrative tasks within specified timeframes

Requirements:

• 3-5 years of relevant experience in regulatory writing
• Experience working in the biopharmaceutical, device, or contract research organization industry
• Strong understanding of EMA, FDA, and ICH regulations, and good publication practices
• Extensive knowledge of English grammar and ability to communicate clearly
• Familiarity with AMA Manual of Style

Benefits:

• Company car or car allowance
• Health benefits, including Medical, Dental, and Vision
• Company match 401k
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO) and sick time