Medical Writer I (Remote – India) | Syneos Health
Location: Remote (India)
Employment Type: Full-time
Salary Range: Not disclosed (competitive industry rate)
Company: Syneos Health
Posted Date: June 13, 2025
Job Summary:
Syneos Health is hiring a Medical Writer I to support its global medical writing operations. This is a fully remote opportunity based in India. As part of a dynamic team, you'll collaborate across clinical, regulatory, and pharmacovigilance functions to draft and edit high-quality documents including clinical trial disclosures, CTD submissions, and safety narratives. This role is ideal for candidates with a postgraduate degree in life sciences and experience in regulatory or clinical writing.
Key Responsibilities:
Draft and edit documents such as clinical study protocols, study reports, amendments, investigator brochures, and patient narratives
Support Clinical Trial Disclosure and CTD document submissions
Review statistical analysis plans, tables, listings, and figures for clarity and accuracy
Perform quality checks on peer documents to ensure regulatory and editorial compliance
Conduct clinical literature searches as required
Ensure compliance with ICH-E3 guidelines, regulatory standards, SOPs, and client-approved templates
Coordinate with biostatistics, data management, regulatory, and clinical teams to ensure timely document delivery
Support safety narrative writing in pharmacovigilance projects
Stay current with industry trends, regulations, and medical writing best practices
Required Skills & Qualifications:
Postgraduate degree in Life Sciences (preferably M.Pharm or PharmD)
1–2 years of experience in medical writing or related clinical trial document preparation
Familiarity with Clinical Trial Disclosure, Regulatory Medical Writing, and Pharmacovigilance (Safety Narratives)
Understanding of global regulatory requirements and ICH guidelines
Experience with platforms such as ClinicalTrials.gov, EUCTR, or results posting for FDA
Proficiency in Microsoft Office Suite and relevant collaborative tools
Excellent written and verbal communication skills in English
Detail-oriented with strong organizational and time management skills
Perks & Benefits:
100% remote work flexibility (India-based)
Career development and internal growth opportunities
Supportive and inclusive work culture
Comprehensive technical and therapeutic training
Recognition programs and competitive compensation
Access to global clinical research expertise and resources
About Syneos Health:
Syneos Health is a global biopharmaceutical solutions organization helping customers accelerate the development and commercialization of therapies. With a footprint in over 110 countries and partnerships on 94% of novel FDA-approved drugs in the last 5 years, Syneos is a leader in clinical, medical affairs, and commercial delivery across the drug development lifecycle.
Work Mode: Remote (India)
Call to Action:
Are you ready to shape the future of clinical research with your medical writing expertise? Apply now to become a Medical Writer I at Syneos Health and make a lasting impact in healthcare and drug development.
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