Sponsor Dedicated Protocol Medical Writer II - Remote based (Canada, US, UK, Serbia)

3004 Syneos Health UK Limited; Canada; Remote; CAD 75,000 - 110,000; Full time

Job summary

Syneos Health is seeking a Sponsor Dedicated Protocol Medical Writer II for a remote role based in Canada, the US, the UK, or Serbia. You will lead protocol development, amendments, and related medical writing activities across studies while ensuring regulatory alignment and high-quality deliverables.

You will mentor junior writers, coordinate across departments, and liaise with clients to meet timelines and budgets in a fast-paced biopharma environment.

Qualifications

• 3–5 years of relevant experience in medical writing, with proven experience in Protocol writing.
• Experience with regulatory requirements (FDA/ICH) and good publication practices.
• Experience collaborating with cross-functional teams on complex studies.

Responsibilities

• Lead medical writing activities for protocol development and amendments.
• Coordinate writing deliverables across departments with minimal supervision.
• Mentor junior writers and ensure document quality and compliance.
• Review and edit clinical study reports, packages, and abstracts for accuracy.
• Engage with clients to resolve questions and manage timelines.

Skills

Medical writing

Protocol writing

Editing/reviewing

Client communication

Tools

Veeva/CARA

Job description

Sponsor Dedicated Protocol Medical Writer II - Remote based (Canada, US, UK, Serbia)

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. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. Discover what our 29,000 employees, across 110 countries already know.

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

The role could be remote based from the following locations: Canada, US, UK, Serbia 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 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. Experience in working with Veeva/CARA. Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style.

Get to know Syneos Health 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. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com

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. Occasionally, required skills/experiences for jobs are expressed in brief terms. 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. Discover what our Syneos Health colleagues already know: work here matters everywhere. 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. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. 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. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. 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 are partners with purpose. 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.