Medical Writer II – Senior Medical Writer

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Syneos Health

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Writes, edits, and coordinates content for clinical/regulatory documents • Leads the clear and accurate completion of medical writing deliverables • Manages medical writing activities associated with individual studies • Completes a variety of documents that may include clinical study protocols, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, and more • Leads the resolution of comments from the client • Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format • Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs • May contribute to development of internal materials and presentations or changes to internal process, standard practices, and capabilities • Mentors and leads less experienced medical writers on complex projects

🎯 Requirements

• Bachelor’s degree in a relevant discipline with relevant writing experience; graduate degree preferred • 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/or good publication practices strongly required • Experience writing relevant document types required • Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style

🏖️ Benefits

• Health benefits to include 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

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