Description
Syneos Health is seeking a Sr. Principal Medical Writer to develop regulatory documents for submission to regulatory agencies globally. The successful candidate will have at least 5 years of medical writing experience in the biopharmaceutical/CRO industry and strong organizational, time management, and project management skills.
Responsibilities:
- 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, timelines, and processes
- Review other documents associated with assigned projects, such as Protocols and Statistical Analysis Plans
- Participate in cross-functional process improvement initiatives
- Mentor more junior medical writing staff
Requirements:
- Bachelor's degree required; advanced degree in a relevant scientific/clinical/regulatory field preferred
- At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required
- Proficiency in organizing and communicating clinical information required with minimal oversight
- Strong organizational, time management, and project management skills required
- Proficient in MS Word; experience with an electronic document management system and templates required
Benefits:
- Company car or car allowance
- Health benefits, including 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
Salary Range: $114,000.00 - $210,900.00