Principal Medical Writer – Publications

🔥 0 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

👻 Ghost score 10%

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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, including document strategy and cross-department coordination • Lead resolution of client comments • Write clinical study protocols, amendments, clinical study reports, patient narratives, investigator brochures, informed consents, plain language summaries, safety reports, clinical development plans, regulatory submissions, journal manuscripts, abstracts, posters, and presentations • Ensure compliance with ICH E3 guidelines, regulatory standards, SOPs, client standards, templates, authorship requirements, and style 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 • 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, escalating as appropriate • Serve as a technical subject matter expert and contribute to internal materials, presentations, processes, and capabilities • Mentor and lead less experienced medical writers • Develop expertise in industry topics and regulatory requirements • Engage externally with industry groups • Monitor project budgets and contribute to bid projections • Communicate status and negotiate timelines and deliverables with medical writing leadership • Represent medical writing on clinical study teams, at conferences, meetings, and client presentations • Complete administrative tasks and other assigned duties

🎯 Requirements

• At least 6 years of relevant experience in science, technical, or medical writing • Extensive experience working in the biopharmaceutical, device, or contract research organization industry • Advanced understanding of FDA and ICH regulations and guidelines and/or good publication practices • Extensive experience writing relevant document types • Extensive knowledge of English grammar and ability to communicate clearly • Strong familiarity with AMA Manual of Style • Experience with complex medical writing deliverables and relevant clinical/regulatory document types • 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 • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Opportunities for career paths and employment progression • Minimal travel requirement (less than 25%)