Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based

Syneos Health, Inc.; Remote; CAD 111,000 - 200,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Sr Medical Writer for a remote position, responsible for developing regulatory documents and ensuring adherence to guidelines. Candidates should have at least 5 years of medical writing experience, strong communication skills, and a thorough knowledge of regulatory processes. The role involves collaboration with multiple departments, leading document reviews, and mentoring junior writers. Competitive benefits including health coverage and performance bonuses are offered. Salary ranges from $80,600 to $145,000 based on qualifications.

Benefits

Health benefits including Medical, Dental and Vision

Company match 401k

Flexible paid time off (PTO)

Qualifications

• At least 5 years of experience in medical writing or regulatory documents.
• Strong knowledge of ICH E3 guidelines and related compliance.
• Proven ability to write clearly and coherently in a scientific manner.

Responsibilities

• Lead the completion of medical writing deliverables accurately.
• Manage various medical writing activities with minimal supervision.
• Review statistical analysis plans ensures grammar and consistency.

Skills

Medical writing

Regulatory standards adherence

Client interaction

Technical writing expertise

Team collaboration

Education

Bachelor's degree in Life Sciences or related field

Job description

Sr Medical Writer - Medical Device + Regulatory Documents - Remote Based

Updated: December 4, 2025
Location: Toronto, ON, Canada

Description

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Servic e 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 accelerate the delivery of therapies, because we are passionate to change lives.

Job Responsibilities

• 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%).

Benefits

We reward and recognize our people by providing valuable benefits and a quality‑of‑life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range

$80,600.00 – $145,000.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

Summary

Roles within the Medical Writing job family are responsible for writing and editing manuscripts and other medical communications on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in‑company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication such as screening, analyzing, and summarizing additional data from other sources as needed. Conducts systematic literature searches and reviews. Prepares literature for new products and revises existing medical communication. Reviews and analyzes statistical outputs to prepare results‑based documents such as clinical study reports and development safety update reports. Supports engagement and interaction with regulatory agencies through preparation of briefing books and response documents to health authority questions.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. 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.

Equal Employment Opportunity

Syneos Health is a diverse, equitable and inclusive workplace committed to guaranteeing equal employment opportunities for all employees and applicants regardless of race, color, religion, sex, national origin, age, disability, or any other protected status in accordance with applicable laws.