Syneos Health
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
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.
Sponsor Dedicated Medical Writer II/Sr
🔥 0 minutes ago
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Syneos Health
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
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
• Lead the clear and accurate completion of medical writing deliverables • Manage medical writing activities associated with individual studies • Coordinate medical writing activities within and across departments with minimal supervision • Lead resolution of client comments • Complete clinical, regulatory, safety, publication, and submission documents • Adhere to regulatory standards, ICH E3 guidelines, company SOPs, client standards, templates, authorship requirements, and style guides • Coordinate quality and editorial reviews • Manage source documentation appropriately • Lead team document reviews and act as a peer reviewer • Review statistical analysis plans and table/figure/listing specifications • Interact with clients and cross-functional teams 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 • Provide technical support, training, and consultation • Contribute to internal materials, presentations, processes, standards, and capabilities • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements • Work within budgeted hours and communicate status and changes to medical writing leadership • Complete required administrative tasks and other assigned duties
🎯 Requirements
• 3–5 years of relevant experience in science, technical, or medical writing • Experience in the biopharmaceutical, medical device, or contract research organization industry required • Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices • Experience writing relevant document types • Extensive knowledge of English grammar • Ability to communicate clearly • Strong familiarity with AMA Manual of Style • Ability to work within budgeted hours and specified timeframes • Minimal travel may be required (less than 25%)
🏖️ Benefits
• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Minimal travel may be required (less than 25%) • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Career paths and employment opportunities • Collaborate with passionate problem solvers • Partner with the most diverse team of experts in the industry
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