Description
Syneos Health is seeking a Sr. / Principal Medical Writer (Regulatory focus) - Sponsor-dedicated; NA/CAN/UK.
The successful candidate will lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. They will manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
Key responsibilities include:
- Leading the resolution of comments from clients
- Completing a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and more
- Adhering to established regulatory standards, including ICH E3 guidelines
- Coordinating quality and editorial reviews
- Acting as a peer reviewer for internal teams
- Reviewing statistical analysis plans and table/figure/listing specifications
- Interacting and building good working relations with clients, department heads, and peers
- Performing online clinical literature searches and complying with copyright requirements
- Identifying and proposing solutions to resolve issues
- Mentoring and leading less experienced medical writers on complex projects
- Developing deep expertise on key topics in the industry and regulatory requirements
- Managing budget specifications for assigned projects
- Completing required administrative tasks within specified timeframes
The ideal candidate will have:
- Minimum of 5 years of lead regulatory writing experience
- Experience with Phase 2 and 3 studies
- Lead writer experience with protocols, submissions, clinical summary of safety modules, and more
- Strong project management skills
- Strong client experience
- Time management skills
- Process experience
In return, Syneos Health offers a range of benefits, including a company car or car allowance, health benefits, company match 401k, eligibility to participate in Employee Stock Purchase Plan, and flexible paid time off.
The salary range for this position is $80,600.00 - $175,700.00.