Medical Writer I – Clinical and Regulatory Writing | Pune | Syneos Health
Job Summary:
Syneos Health is seeking a Medical Writer I in Pune to support regulatory medical writing and clinical trial document development. This role is ideal for candidates with a background in M.Pharm, PharmD, or life sciences, and offers the opportunity to contribute to regulatory submissions and clinical study documentation. Be part of a company that supports 94% of FDA-approved drugs and accelerates global biopharma success.
Key Responsibilities:
Write and compile clinical and regulatory documents such as protocols, clinical study reports (CSRs), patient narratives, and investigator brochures
Adhere to ICH-E3, company SOPs, and client templates for compliance and consistency
Review statistical analysis plans and outputs, ensuring data presentation accuracy
Conduct online literature reviews to support scientific content
Participate in internal meetings with cross-functional teams including biostatistics, regulatory affairs, and medical affairs
Track project timelines and deliverables to ensure on-time and on-budget completion
Support the preparation and quality control of CTD submissions
Maintain familiarity with evolving regulatory guidance and best practices
Required Skills & Qualifications:
Postgraduate degree in Life Sciences, preferably M.Pharm or PharmD
Experience with regulatory medical writing, clinical trial disclosure, or pharmacovigilance (safety narratives)
Proficiency in clinical trial results posting (e.g., ClinicalTrials.gov, EUCTR)
Familiarity with ICH-E3 guidelines and regulatory documentation requirements
Strong written and verbal communication skills
Proficiency in Microsoft Office tools: Word, Excel, PowerPoint
Self-motivated and able to manage multiple tasks independently
Perks & Benefits:
Structured career development and global mobility opportunities
Strong emphasis on employee well-being and inclusion
Access to advanced training platforms and mentoring
A global, collaborative work culture supporting remote interactions
Work with international teams contributing to regulatory success of new therapies
Company Description:
Syneos Health is a leading global integrated biopharmaceutical solutions provider, delivering results across clinical development, regulatory affairs, and commercial strategy. With operations in 110 countries and a role in supporting 94% of all novel FDA drug approvals, Syneos is committed to accelerating healthcare innovation worldwide.
Work Mode:
On-site – Pune, India
Call to Action:
Are you ready to launch your career in regulatory medical writing with a global leader? Apply today to become a Medical Writer I at Syneos Health and make a measurable difference in advancing healthcare innovations.
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