Syneos Health® is a leading fully integrated biopharmaceutical solutions organization, accelerating customer success through clinical, medical affairs, and commercial expertise. With 29,000 employees across 110 countries, Syneos Health has supported 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products in the last five years.
The company fosters a Total Self culture, emphasizing diversity, inclusion, and career growth, making it a top workplace in the pharma industry.
Detailed Job Description
Job Title: Medical Writer I (CTT)
Location: Pune, India
Job ID: 25000363
Updated: Recently
Key Responsibilities:
- Serve as a medical writer for clinical study/regulatory projects.
- Assist in writing, editing, and coordinating clinical/regulatory documents.
- Work on Clinical Trial Disclosures (CTT), including protocol registration and results posting for regulatory bodies.
- Prepare and review:
- Clinical study protocols & amendments
- Clinical study reports (CSRs)
- Patient narratives
- Investigator brochures
- Ensure compliance with ICH-E3 guidelines and client-specific standards.
- Collaborate with data management, biostatistics, and regulatory teams.
- Perform literature searches and stay updated with regulatory guidelines.
Eligibility Criteria:
- Minimum 1 year of experience in Clinical Trial Disclosure (CTT) or related medical writing.
- B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Life Sciences, Ph.D. in Life Sciences, Ph.D. in Pharmacy, Ph.D. in Medical Sciences, MBBS, BDS, BHMS, BAMS, Postgraduate Diploma in Clinical Research, Postgraduate Diploma in Medical Writing
- Experience in protocol registration, results registration, and regulatory submissions.
- Strong understanding of clinical research documentation and statistical analysis plans.
- Excellent scientific writing, editing, and communication skills.
- Ability to work under moderate supervision and meet deadlines.
Benefits & Why Join Syneos Health?
✅ Career Growth: Professional development in medical writing & regulatory affairs.
✅ Global Impact: Work on cutting-edge clinical trials with top biopharma clients.
✅ Inclusive Culture: Emphasis on diversity, equity, and work-life balance.
✅ Learning Opportunities: Access to technical & therapeutic training programs.
✅ Competitive Compensation: Attractive salary & benefits package.
