Sponsor Dedicated Senior Medical Writer (Regulatory Submission Documents) - Canada Remote Based

Syneos Health; Canada; Remote; CAD 90,000 - 130,000; Full time

Job summary

Syneos Health, Inc. is seeking a Sponsor Dedicated Senior Medical Writer to support regulatory submission documents from a Canada-based, remote location.

You will lead medical writing deliverables, coordinate with Clinical Scientists, and ensure compliant, timely submissions across protocols, amendments, and reports. The role emphasizes collaboration with cross-functional teams, adherence to ICH guidelines, and mentoring junior writers while maintaining quality and budget targets.

Qualifications

• 3-5 years of medical writing experience.
• Experience with protocols, clinical study reports, and regulatory submissions.
• Ability to coordinate with cross-functional teams and meet timelines.

Responsibilities

• Leads the preparation of medical writing deliverables for protocols and amendments.
• Coordinates with Clinical Scientist and regulatory teams to ensure accuracy and compliance.
• Mentors junior medical writers on complex projects.
• Ensures documents meet ICH guidelines and client templates on time and within budget.

Skills

Medical writing

Protocols

Regulatory submissions

Quality assurance

Job description

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.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.

• We are continuously building the company we all want to work for and our customers want to work with. Why? 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.

Job Responsibilities

The role could be remote based from the following locations: US or Canada

This Sponsor dedicated role will involve partnering closely with Clinical Scientist and will be focused on Protocols and Protocol Amendments.

• Leads the clear 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.


• Leads the resolution of comments from the client.


• Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; 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. Ensures source documentation is managed appropriately.


• 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. Provides feedback to further define statistical output required and document needs.


• 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.


• Identifies and proposes solutions to resolve issues, escalating as appropriate. 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.


• Performs other work-related duties as assigned.


• Minimal travel may be required (less than 25%).

Qualifications

3-5 years of relevant experience in medical writing, with proven experience in Protoc