Description
Syneos Health is seeking a Sr. Medical Writer to join their team. The successful candidate will have a minimum of 4-5 years of experience in medical writing, with experience working on PK/PD studies, CSR, IB, ICF, protocols, and Phase II/Phase III studies.
The Sr. Medical Writer 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 with minimal supervision, and lead the resolution of comments from clients.
Responsibilities:
- Lead the completion of medical writing deliverables, such as clinical study protocols, clinical study reports, patient narratives, and investigator brochures
- 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 heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs
- Perform online clinical literature searches and comply with copyright requirements
- Identify and propose solutions to resolve issues, and provide technical support, training, and consultation to department and other company staff
- Mentor and lead less experienced medical writers on complex projects
- Develop deep expertise on key topics in the industry and regulatory requirements and guidelines that affect medical writing
- Manage budget specifications for assigned projects, working within budgeted hours and communicating status and changes to medical writing leadership
Qualifications:
- 3-5 years of relevant experience in science, technical, or medical writing
- Experience working in the biopharmaceutical, device, or contract research organization industry
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and good publication practices
- Extensive knowledge of English grammar and ability to communicate clearly
Benefits:
- Career development and progression opportunities
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture