Job Summary:
Syneos Health, a global leader in biopharmaceutical solutions, is hiring a Medical Writer II in Pune, Maharashtra. This role demands expertise in Clinical Trial Disclosure (CTD), Clinical Trial Transparency (CTT), and regulatory medical writing. The ideal candidate will possess 3+ years of relevant experience and a strong understanding of FDA and ICH guidelines. Join Syneos Health and contribute to breakthrough therapies impacting global healthcare.
Key Responsibilities:
Mentor and guide junior medical writers on various projects.
Compile, write, and edit clinical and regulatory documents such as protocols, reports, narratives, and brochures.
Review statistical analysis plans and specifications for content accuracy and consistency.
Collaborate with cross-functional teams like Data Management, Biostatistics, Regulatory, and Medical Affairs.
Conduct peer reviews ensuring scientific clarity, format adherence, and regulatory compliance (ICH-E3, SOPs).
Perform literature searches and stay updated with evolving medical writing standards.
Ensure budget compliance and timely task completion.
Handle additional responsibilities as assigned with minimal travel (less than 25%).
Required Skills & Qualifications:
Minimum 3 years of experience in CTD, CTT, and regulatory medical writing.
Proficiency in posting results for regulatory bodies (e.g., FDA, ClinicalTrials.gov, EudraCT).
Bachelor’s in Science (preferred) or Arts with medical/scientific expertise.
Strong command of English grammar, FDA/ICH regulations, and AMA style.
High independence level with leadership, proofreading, and presentation skills.
Skilled in MS Word, Excel, PowerPoint, and internet research.
Familiarity with clinical research principles and complex data interpretation.
Perks & Benefits:
Career growth and progression opportunities.
Comprehensive technical and therapeutic area training.
Total rewards and peer recognition programs.
Inclusive “Total Self” company culture.
Global exposure across 110+ countries and 29,000 employees.
Company Description:
Syneos Health is a globally recognized biopharmaceutical solutions provider, partnering across clinical, medical affairs, and commercial sectors. Known for innovation and operational excellence, Syneos Health accelerates therapy delivery to patients worldwide by merging scientific rigor with market insight.
Work Mode: On-site (Pune, Maharashtra, India)
Call to Action:
Interested candidates who meet the qualifications are encouraged to apply today and become part of Syneos Health’s transformative journey in global healthcare.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Croatia |Zagreb :
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Japan | Saitama |Tokyo :
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