Join Now
Syneos Health, a leading global biopharmaceutical solutions organization, is hiring a Medical Writer II (CSR Narrative, QC Review) (Job ID: 25000321) for our team in Pune, India. Join us to accelerate the delivery of life-changing therapies.
About Syneos Health
Founded in 1998, Syneos Health is a fully integrated clinical research organization (CRO) operating in 110 countries with 29,000 employees. We drive innovation in clinical development, medical affairs, and commercial solutions, adhering to US FDA, EMA, and ICH standards. Our Total Self culture fosters inclusion and collaboration.
Why Join Syneos Health?
Join a Great Place to Work certified organization (rated 4.0/5 for culture). Enjoy competitive benefits, career development, and the opportunity to impact global patient outcomes in a supportive, diverse environment.
Medical Writer II Role (Job ID: 25000321)
- Location: Pune, India
- Job Type: Full-Time
- Posted: June 27, 2025
Responsibilities
- Author and edit clinical study reports (CSRs), patient narratives, protocols, investigator brochures, and annual reports with minimal supervision.
- Perform QC review of CSRs and narratives for scientific content, clarity, and compliance.
- Review statistical analysis plans and table/figure/listing specifications for accuracy and consistency.
- Collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams.
- Conduct online clinical literature searches as needed.
- Ensure compliance with ICH-E3 guidelines, company SOPs, and client standards.
- Mentor less experienced medical writers and manage project budgets.
Your Profile
- Qualifications:
- B.Sc. in a relevant field with writing experience, or B.A. in Social Sciences, English, or Communications with scientific/medical expertise.
- Preferred: M.Sc., B.Pharm, or M.Pharm.
- Experience: Minimum 3 years in medical writing, including independent CSR narrative authoring and QC review.
- Skills:
- Extensive knowledge of English grammar, FDA, ICH regulations, and AMA style guide.
- Proficiency in Microsoft Word, Excel, PowerPoint, email, and internet tools.
- Strong analytical, proofreading, and interpersonal skills.
- Familiarity with clinical research principles and data interpretation.
Why This Role Matters
As a Medical Writer II, you’ll ensure scientific accuracy and regulatory compliance in clinical documentation, directly contributing to the success of clinical trials and global patient safety.
Benefits of Joining Syneos Health
- Competitive salary and total rewards program.
- Career development through technical and therapeutic training.
- Health insurance and wellness programs.
- Peer recognition and supportive management.
- Minimal travel (less than 25%).
How to Apply
Apply online at Syneos Health Careers using Job ID: 25000321. Submit your resume and required details. Not ready to apply? Join our Talent Network to stay connected for future opportunities.
Verified by Trusted HRs
The post is released by the Syneos Health Official Webpage. Click here to visit the post
Application Process
- Step 1: Apply online with Job ID 25000321.
- Step 2: HR reviews applications for eligibility.
- Step 3: Interviews scheduled (virtual or in-person).
- Step 4: Final selection and offer process.
Commitment to Inclusion
Syneos Health is dedicated to a diverse and inclusive workplace, free from discrimination based on race, color, religion, sex, sexual orientation, gender identity, disability, or veteran status. We comply with the Americans with Disabilities Act and provide reasonable accommodations as needed.
About Our Facility
Our Pune office supports clinical development, medical writing, and data management, contributing to 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past 5 years. Learn more at Syneos Health.
Join Our Mission
Join Syneos Health to change lives through innovative clinical solutions. Apply today for the Medical Writer II role (Job ID: 25000321) in Pune. Don’t meet all requirements? Apply anyway—your transferable skills could make you the perfect fit!