Description
Syneos Health is seeking a Sr Medical Writer - Sponsor-dedicated to work remotely from locations in the UK, Poland, Spain, or Serbia.
As a Sr 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 clients.
Responsibilities:
- Lead the completion of various medical writing deliverables, including clinical study protocols, clinical study reports, patient narratives, and more
- Adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures
- 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, as necessary
- 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 required
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and good publication practices
- Experience writing relevant document types required
- Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style