Sr Regulatory Medical Writer - CSR - Remote Home Based

Sr Regulatory Medical Writer – CSR – Remote Home Based

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 continuously work to simplify and streamline our work to make Syneos Health 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.

Job Responsibilities

• Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manage medical writing activities associated with individual studies, coordinating activities within and across departments with minimal supervision. Lead the resolution of client comments.
• Complete a variety of documents including clinical study protocols and 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.
• Adhere to established regulatory standards, including ICH E3 guidelines, as well as company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides, ensuring projects are completed on time and on budget.
• Coordinate quality and editorial reviews. Ensure source documentation is managed appropriately. Lead team document reviews and review documents as needed.
• Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format.
• Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency. Provide feedback to define statistical output requirements and document needs.
• Interact and build working relationships with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce high‑quality deliverables.
• Perform online clinical literature searches and comply with copyright requirements.
• Identify and propose solutions to resolve issues, escalating as appropriate. Provide technical support, training, and consultation to department and other company staff. May contribute to the development of internal materials and presentations or changes to internal processes, standard practices, and capabilities.
• Mentor and lead less experienced medical writers on complex projects when necessary.
• Develop deep expertise on key industry topics and regulatory requirements and guidelines that affect medical writing.
• Maintain awareness of budget specifications for assigned projects, working within budgeted hours and communicating status and changes to medical writing leadership.
• Complete required administrative tasks within specified timeframes.
• Perform other work‑related duties as assigned.
• Minimal travel may be required (less than 25%).

Seniority Level

• Mid‑Senior level

Employment Type

• Full‑time

Job Function

• Marketing, Public Relations, and Writing/Editing

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. 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.

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. They conduct systematic literature searches and reviews, prepare literature for new products, revise existing medical communication, and review and analyze statistical outputs to prepare results‑based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through preparation of briefing books and response documents to health authority questions. Individual contributors typically manage up to two employees, may direct lower‑level professionals or manage processes and programs, and spend the majority of time contributing to the design, implementation, or delivery of processes, programs, or policies.