Medical Writer II (CSR Narrative Experience) – Syneos Health, Pune
Location: Pune, Maharashtra, India
Work Mode: On-site
Experience Required: Minimum 3 years in medical writing; minimum 3 years specifically in CSR Narrative writing
Job ID: 25003692
Salary Range: Not specified
Job Summary
Syneos Health is hiring a Medical Writer II with specialized experience in CSR narrative writing. If you're an experienced clinical writer with strong narrative development expertise and looking to join a global biopharmaceutical leader in Pune, this opportunity is for you. This role demands deep familiarity with ICH-E3, FDA regulations, and proven independent authorship of CSR narratives within the pharmaceutical and clinical research landscape.
Key Responsibilities
Independently compile, write, and edit deliverables including CSR narratives, protocols, and annual reports.
Mentor junior writers and serve as a peer reviewer ensuring scientific accuracy and regulatory compliance.
Review and edit statistical analysis plans, TFL specifications, and clinical content documents.
Collaborate with cross-functional teams (data management, biostats, regulatory) to produce compliant documents.
Conduct online literature searches and stay updated on regulatory and medical writing standards.
Adhere to ICH-E3, company SOPs, and client templates for deliverables.
Ensure quality and budget adherence for assigned writing projects.
Provide status updates, meet timelines, and participate in team reviews.
Required Skills & Qualifications
Minimum 3 years of medical writing experience with at least 3 years in CSR Narrative writing.
Bachelor’s in Science or Arts (life sciences, English, communications preferred).
Proven expertise in independent authoring and reviewing CSR narratives.
Knowledge of ICH-E3, FDA, and AMA style guidelines.
Excellent writing, proofreading, and communication skills.
Strong MS Office proficiency (Word, Excel, PowerPoint).
Familiarity with clinical research principles and interpretation of complex clinical data.
Perks & Benefits
Comprehensive career development and training support
Collaborative work environment with global teams
Access to therapeutic area training and professional mentorship
Recognition through peer-based awards and rewards
Total rewards program aligned with global healthcare industry standards
Opportunity to work with 94% of all FDA-approved drugs over the last 5 years
About the Company
Syneos Health is a global, fully integrated biopharmaceutical services organization offering world-class clinical development, real-world evidence, and commercial solutions. Known for accelerating drug development through innovation and cross-functional collaboration, Syneos operates across 110 countries with a workforce of over 29,000.
Call to Action
Are you a detail-oriented medical writer with CSR narrative experience ready to make an impact in global clinical trials?
Apply now to join Syneos Health and take the next big step in your pharmaceutical writing career.
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