Principal Medical Writer – Publications

🔥 1 minute ago

🍁 Vermont – Remote

🍁 Vermont – Remote

💵 $80.6k - $175.7k / year

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

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Syneos Health

WebsiteLinkedInAll Job Openings

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 clear and accurate completion of complex medical writing deliverables • Manage medical writing activities for individual studies, define document strategy, and coordinate activities across departments • Complete clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations • Apply regulatory standards, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides • Advise clients and study teams on data presentation and production strategies • Lead document reviews and coordinate quality and editorial reviews • Serve as an expert peer reviewer and technical subject-matter expert • Review statistical analysis plans and table/figure/listing specifications • Collaborate with clients and teams in data management, biostatistics, regulatory affairs, and medical affairs • Perform online clinical literature searches and comply with copyright requirements • Identify and resolve issues, contribute to internal materials, processes, standards, and capabilities • Mentor and lead less experienced medical writers • Develop expertise in industry topics and regulatory requirements; engage with industry groups • Monitor project budgets, contribute to bid projections, and communicate status and changes • Represent medical writing on study teams, at conferences, meetings, and client presentations • Complete administrative tasks and other assigned duties • Minimal travel may be required, less than 25%

🎯 Requirements

• Experience and deep expertise in medical writing and clinical research documentation • Ability to lead complex medical writing deliverables with minimal supervision • Knowledge of ICH E3 guidelines and regulatory standards • Knowledge of company standard operating procedures, client standards, approved templates, authorship requirements, and style and formatting guides • Ability to advise clients and study teams on data presentation and production strategies • Ability to review statistical analysis plans and table/figure/listing specifications • Ability to perform online clinical literature searches and comply with copyright requirements • Expertise in industry topics and regulatory requirements affecting medical writing • Ability to mentor and lead less experienced medical writers • Ability to negotiate timelines and assigned deliverables • Minimal travel availability, less than 25% • Equivalent experience, skills, and/or education will also be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Company car or car allowance • Medical, Dental and Vision health benefits • 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) • Sick time