Sr Regulatory Medical Writer - CSR - Remote Home Based

Sr Regulatory Medical Writer - CSR - Remote Home Based

Updated: December 3, 2025
Location: London, LND, United Kingdom
Job ID:-OTHLOC-3526-2DR

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 so that we are easier to work with and easier to work for.

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 accelerate the delivery of therapies, because we are passionate about changing lives.

Our worldwide team of 29,000 employees is dedicated to developing people, supporting and engaging line management, providing training and recognition, and building a culture where everyone can belong.

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 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 for scientific meetings.
• Adheres to established regulatory standards, including but not limited to ICH E3 guidelines, company standard operating procedures, client standards, and company or client approved templates, authorship requirements, and style and formatting guides, completing 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 a 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 heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs 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 industry topics 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%).

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 in a highly competitive and ever changing environment. Learn more about Syneos Health.

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. Occasional brief expressions of required skills/experiences for jobs are allowed. All language 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, providing reasonable accommodations to assist employees or applicants to perform the essential functions of the job.

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. They conduct systematic literature searches and reviews, prepare literature for new products and revise existing medical communication, review and analyze statistical outputs to prepare results based documents such as clinical study reports and development safety update reports, and support engagement and interaction with regulatory agencies through preparation of briefing books and response documents to health authority questions.

Individual contributors with responsibility in a professional or technical discipline may manage two or fewer employees. They may direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. They are responsible for entire projects or processes within the area of responsibility and develop subject matter expertise.

Culture and Career

Syneos Health (Nasdaq:SYNH) 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. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers' delivery of important therapies to patients. We support a diverse, equitable and inclusive culture.