Job Title:
Medical Writer II (Clinical Trial Transparency)
Updated:
Yesterday
Location:
India-Asia Pacific – IND-Gurugram-Hybrid, India
Job ID:
25002559-IND002
Company:
Syneos Health®
About Syneos Health:
Syneos Health® is a fully integrated biopharmaceutical solutions company committed to accelerating customer success. Operating in 110 countries with over 29,000 employees, it brings clinical, medical, and commercial insights to drive patient-centered outcomes.
Why Work at Syneos Health:
Career growth and progression opportunities
Inclusive Total Self culture for authenticity and belonging
Strong focus on training, peer recognition, and rewards
Passionate, global team driving real-world health impacts
Job Responsibilities:
Writing & Documentation
Independently compile, write, and edit clinical and regulatory documents, including:
Clinical study protocols and amendments
Clinical study reports (CSRs)
Patient narratives
Annual reports
Investigator brochures
Review statistical analysis plans and related outputs for accuracy and clarity
Ensure scientific accuracy, consistency, and adherence to templates and regulatory standards
Conduct literature searches as needed
Maintain awareness of timelines and budget
Collaboration & Mentorship
Collaborate with cross-functional departments (e.g., biostatistics, data management, regulatory)
Mentor junior medical writers
Participate in internal peer reviews and address reviewer comments appropriately
Compliance & Standards
Follow ICH-E3 guidelines, FDA/EMA regulations, and company/client SOPs
Adhere to AMA style and maintain documentation quality and compliance
Stay updated with evolving regulatory guidelines and industry practices
Qualifications:
Education & Experience
Required:
Bachelor of Science (life sciences) with relevant writing experience
OR Bachelor of Arts (English, Communications, or Social Sciences) with scientific/medical knowledge
Skills & Competencies
Proficient in English grammar, with strong understanding of FDA/ICH guidelines
Familiarity with AMA style guide
Strong presentation, editing, interpersonal, and leadership abilities
Skilled in Microsoft Office tools (Word, Excel, PowerPoint), email, and internet research
Ability to interpret and present clinical data accurately
Additional Information:
Minimal travel required (less than 25%)
Responsibilities are subject to change at company’s discretion
The company complies with global employment equality and accessibility standards
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