Principal Medical Writer - Regulatory Submission Documents

Updated: December 3, 2025

Location: Warsaw, MZ, Poland

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 these activities within and across departments with minimal supervision
• Complete a variety of documents, including clinical study protocols, amendments, 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, and abstracts, posters, and presentations for scientific meetings
• Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides
• Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately
• 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, providing feedback to further define statistical output required and document needs
• Interact and build good working relations with clients, department heads and peers in data management, biostatistics, regulatory affairs and medical affairs to produce writing deliverables
• Perform online clinical literature searches and comply with copyright requirements
• Identify and propose solutions to resolve issues, providing technical support, training and consultation to department and other company staff
• Mentor and lead less experienced medical writers on complex projects
• Develop deep expertise on key topics in the industry and regulatory requirements
• Work within budget specifications for assigned projects

Qualifications

• Bachelors degree in a relevant discipline with relevant writing experience; graduate degree preferred
• 3-5 years of relevant experience in science, technical or medical writing
• Experience working in the biopharmaceutical, device or contract research organization industry required
• Strong understanding of FDA and ICH regulations, other regulatory guidelines and/or good publication practices strongly required
• Experience writing relevant document types required
• Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style

Necessary Skills

• Strong presentation, proofreading, collaborative and interpersonal skills
• Strong project and time management skills
• Strong proficiency in MS Office
• Strong understanding of medical terminology, principles of clinical research and how to interpret and present clinical data and other complex information

Summary

Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. They prepare and revise documents, conduct literature searches, and support interactions with regulatory agencies through briefing books and response documents.

Benefits

At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop and advance. 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 (Medical, Dental, and Vision), company match 401k, eligibility to participate in the Employee Stock Purchase Plan, eligibility to earn commissions/bonuses 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 may vary depending on location. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range

$80,600.00 - $145,000.00

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. This statement complies with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive. 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.