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, such as clinical study protocols, clinical study reports, patient narratives, and regulatory submissions
- Coordinate medical writing activities within and across departments
- Ensure scientific information is presented clearly and accurately
- Lead the resolution of comments from the client
- Adhere to established regulatory standards, including ICH E3 guidelines
- Coordinate quality and editorial reviews
- Act as peer reviewer for internal team
- 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
- Complete required administrative tasks within specified timeframes
Qualifications:
- 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 a must
- Process experience is a plus
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture
Location: Remote (open to US, UK, and Canada) Travel: Minimal travel may be required (less than 25%)