Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents) - Canada Remote Based Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical

Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. technical and therapeutic area training; We are committed to building an inclusive culture – where you can authentically be yourself.

We are continuously building the company we all want to work for and our customers want to work with. Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. The role could be remote based from the following locations: Leads the transparent and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.

Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. plain language summaries; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides,



when completing medical writing projects, on time and on budget. Coordinates quality and editorial reviews.

Leads team document reviews, and reviews documents as needed. Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.

Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Performs online clinical literature searches and complies with copyright requirements. Provides technical support, training, and consultation to department and other company staff.

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, as necessary. Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing.

Aware of budget specifications for assigned projects, working within the budgeted hours and communicating status and changes to medical writing leadership. Completes required administrative tasks within the specified timeframes. Minimal travel may be required (less than 25%). 3-5 years of relevant experience in medical writing, with proven experience in Protocol writing Experience working in the biopharmaceutical, device, or contract research organization industry required.

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 strongly required.

Experience writing relevant document types required. Extensive knowledge of English grammar and ability to communicate clearly; Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. Further, nothing contained herein should be construed to create an employment contract.

Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers' delivery of important therapies to patients.

Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. A career with Syneos Health means your everyday work improves patients' lives around the world. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams.

With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We integrate seamlessly with our customers and do what's best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.

📌 Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents) - Canada Remote Based (Montreal)
🏢 Syneos Health Canada
📍 Montreal