Syneos Health® is a top-tier, integrated biopharmaceutical solutions provider, committed to accelerating customer success. Operating across 110 countries with a workforce of 29,000 employees, the company provides clinical, medical affairs, and commercial solutions. Syneos Health focuses on streamlining clinical development and delivering therapies faster by putting customers and patients at the center of its operations. With a collaborative work environment, Syneos Health embraces diversity through its Total Self culture—a framework designed to promote authenticity, career growth, and employee well-being.
The company has been involved with 94% of all FDA-approved drugs and 95% of EMA-authorized products over the past five years, working across 200 studies, 73,000 sites, and 675,000+ trial patients.
Responsibilities in the Job
A Medical Writer I at Syneos Health plays a crucial role in ensuring high-quality medical documentation. The key responsibilities include:
- Developing and reviewing clinical documents such as:
- Clinical study protocols and amendments
- Clinical study reports
- Investigator brochures
- Patient narratives
- Collaborating with cross-functional teams, including biostatistics, regulatory affairs, and data management, to complete writing assignments.
- Reviewing statistical analysis plans and providing feedback on outputs.
- Adhering to ICH-E3 guidelines, company SOPs, and client-approved templates to meet regulatory standards.
- Performing online clinical literature searches to support document development.
- Staying up to date with the latest regulatory guidelines and participating in professional development.
- Managing projects within allocated budgets and timelines while communicating necessary changes to leadership.
- Completing administrative tasks and participating in occasional travel (less than 25%).
Qualifications and Skills
The ideal candidate for the Medical Writer I position should meet the following criteria:
- Education:
- Master’s or Doctoral degree in a relevant scientific/medical field.
- Experience:
- Minimum 1 year of experience in medical writing, with expertise in both authoring and reviewing documents.
- Communication and Language Skills:
- Proficient in English grammar, with familiarity with the AMA Style Guide.
- Effective presentation, interpersonal, and proofreading skills.
- Regulatory Knowledge:
- Understanding of FDA and ICH regulations and guidelines.
- Technical Proficiency:
- Expertise in Microsoft Word, Excel, PowerPoint, and internet research.
- Other Abilities:
- Familiarity with clinical research principles and the ability to interpret complex clinical data.
