Description
Syneos Health is seeking a Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated; NA/CAN/UK.
As a Sr. / Principal Medical Writer, you will lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. You will manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. You will also lead the resolution of comments from the client.
Responsibilities:
- Lead the completion of medical writing deliverables, including clinical study protocols, clinical study reports, patient narratives, and regulatory submissions
- Coordinate medical writing activities within and across departments
- Lead the resolution of comments from clients
- Adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures
- Coordinate quality and editorial reviews
- Act as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format
- Review statistical analysis plans and table/figure/listing specifications
- 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
- 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
Requirements:
- Minimum of 5 years of lead regulatory writing experience
- Experience with Phase 2 and 3
- Lead writer experience with protocols, submissions, clinical Summary of Safety (CTD) Modules 2.7.3 and 2.7.4, CSRs (Clinical Study Reports), IBs (Investigator Brochure), Patient Narratives, Safety Aggregate Reports, Briefing books, ISE and ISS (Integrated Summary Efficacy and Integrated Summary Safety)
- Strong project management skills
- Strong client experience
- Time management skills
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