Senior Medical Writer – Regulatory Submission Documents

🔥 13 hours ago

🌐 Canada, United States – Remote

🇨🇦 Canada – Remote 🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🏥📝 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

• Partner closely with Clinical Scientists on protocols and protocol amendments • Lead clear and accurate completion of medical writing deliverables • Manage medical writing activities for individual studies with minimal supervision • Coordinate medical writing activities within and across departments • Lead resolution of client comments • 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 • Follow ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides • Coordinate quality and editorial reviews and manage source documentation • Lead team document reviews and act as a 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 propose solutions, escalating issues as appropriate • 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 affecting medical writing • Work within budgeted hours and communicate status and changes to medical writing leadership • Complete administrative tasks and other assigned duties

🎯 Requirements

• 3-5 years of relevant experience in medical writing, including proven Protocol writing experience • Experience working in the biopharmaceutical, device, or contract research organization industry • Experience with late development • Experience with Oncology/Hematology/Cell therapy • Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices • Experience writing relevant document types • Experience working with Veeva/CARA • Extensive knowledge of English grammar and ability to communicate clearly • Strong familiarity with AMA Manual of Style • Minimal travel may be required (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 • Total rewards program • Inclusive culture • Minimal travel requirement (less than 25%)

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