Syneos Health® is a leading biopharmaceutical solutions organization focused on accelerating customer success by combining clinical, medical affairs, and commercial insights. With over 29,000 employees across 110 countries, Syneos Health plays a pivotal role in delivering innovative therapies to the market. Whether through functional service partnerships or full-service offerings, the company fosters collaboration to drive results. Known for its Total Self culture, Syneos Health embraces diversity, inclusion, and employee well-being to create a meaningful, supportive work environment.
Job Responsibilities
As a Medical Writer II you will:
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- Develop, compile, and edit medical documents in coordination with various departments.
- Author a range of medical writing deliverables such as:
- Clinical study protocols and amendments
- Clinical study reports
- Investigator brochures
- Patient narratives
- Collaborate with teams in biostatistics, data management, regulatory, and medical affairs.
- Review statistical analysis plans and outputs for grammar, format, and consistency, providing relevant feedback.
- Ensure adherence to regulatory guidelines like ICH-E3 and company SOPs while working within timelines and budgets.
- Stay updated on regulatory developments and enhance writing expertise through professional development.
- Conduct literature searches to support ongoing projects.
- Fulfill administrative tasks and manage project timelines.
- Minimal travel (less than 25%) may be required.
Qualifications
To be eligible for the Medical Writer II position, candidates must meet the following criteria:
- Minimum of 1 year of relevant experience in medical writing.
- Expertise in both authoring and reviewing medical documents.
- Master’s or Doctoral degree in a scientific or medical field.
- Strong command of English grammar with familiarity with the AMA style guide.
- Knowledge of FDA and ICH regulations is preferred.
- Effective skills in presentation, proofreading, and teamwork.
- Proficiency in MS Word, Excel, PowerPoint, email tools, and Internet research.
- Ability to interpret and present clinical data and research findings.
Required Skills
- Excellent communication and interpersonal skills.
- Familiarity with clinical research principles.
- Strong attention to detail for accurate editing and review.
- Ability to work within budgeted hours and communicate adjustments promptly.
- Team-oriented, adaptable, and open to learning new skills.
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