Syneos Health®, a global leader in biopharmaceutical solutions, is currently seeking a Medical Writer I (CTD/CTT) to join their dynamic team remotely in India. If you have experience or interest in clinical trial disclosure and regulatory medical writing, this is an excellent opportunity to advance your career with a top-tier organization that drives innovation in healthcare.
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About Syneos Health
Syneos Health® is an integrated biopharmaceutical solutions company operating in over 110 countries. The company focuses on accelerating customer success by translating clinical, commercial, and medical insights into impactful outcomes.
With more than 29,000 employees worldwide, Syneos is committed to fostering an inclusive culture where diverse talents thrive and contribute to meaningful work that changes lives.
Job Description – Medical Writer I (CTD/CTT)
Key Responsibilities:
- Prepare, write, and edit clinical regulatory documents including clinical study protocols, protocol amendments, clinical study reports, patient narratives, and investigator brochures.
- Perform protocol and results registration, ensuring high-quality documentation and compliance with ICH-E3 and other regulatory guidelines.
- Review statistical analysis plans and tables for content, grammar, format, and consistency. Provide feedback to clarify statistical outputs.
- Collaborate closely with cross-functional teams such as data management, biostatistics, regulatory affairs, and medical affairs to deliver quality writing projects on time.
- Conduct clinical literature searches to support document preparation as needed.
- Maintain compliance with company SOPs, client standards, and regulatory templates, managing projects within allotted budgets and timelines.
- Support continuous professional development to stay current with regulatory guidance and enhance writing skills.
- Perform assigned administrative tasks within set deadlines and contribute to team goals.
Desired Experience and Skills:
- Minimum 6 months to 1 year of experience in clinical trial disclosure (CTD/CTT) or in related medical writing roles.
- Strong communication skills and client management aptitude.
- Familiarity with clinical trial protocols, result registrations, and regulatory document requirements.
- Detail-oriented with an ability to work under moderate supervision and manage multiple priorities.
- Knowledge of regulatory standards (including ICH guidelines) and experience with medical writing software tools is a plus.
Why Work at Syneos Health?
- Be part of a global biopharmaceutical company driving innovations in drug development and commercial services.
- Engage in meaningful work with access to extensive career development, therapeutic area training, and peer recognition programs.
- Thrive in an inclusive, supportive culture promoting authenticity and diversity.
- Work remotely with flexible arrangements that support work-life balance.
- Join a company dedicated to bringing novel FDA-approved drugs and EMA-authorized products to market.
How to Apply
Visit Syneos Health’s careers page and apply for the Medical Writer I (CTD/CTT) position here. Candidates are encouraged to join the Talent Network to stay connected with future opportunities.
Verified Medical Writer Job
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Take the next step in your clinical writing career with Syneos Health, where your work matters everywhere.