Syneos Health is Hiring a Medical Writer II (CSR & QC Review) in Pune

• Location: Pune, India
• Job Type: Full-Time
• Posted: June 27, 2025
• Job ID: 25000321

About Syneos Health

Syneos Health is a leading global biopharmaceutical solutions organization, driving innovation in clinical development, medical affairs, and commercial solutions. With operations in 110 countries and a team of 29,000 professionals, we accelerate the delivery of life-changing therapies while adhering to US FDA, EMA, and ICH standards. Recognized as a Great Place to Work (rated 4.0/5), we foster a collaborative, inclusive culture that empowers employees to make a global impact.

Why Join Syneos Health?

Competitive salary & benefits (health insurance, wellness programs)
Career growth with technical & therapeutic training
Supportive, diverse workplace with minimal travel (<25%)
Direct impact on clinical trials & patient safety

Medical Writer II – Job Responsibilities

✔ Author & edit clinical study reports (CSRs), protocols, investigator brochures, and patient narratives with minimal supervision.
✔ Perform QC reviews of CSRs for scientific accuracy, clarity, and compliance with ICH-E3 guidelines.
✔ Collaborate with biostatistics, regulatory affairs, and medical teams to ensure data consistency.
✔ Conduct clinical literature searches and mentor junior writers.
✔ Ensure adherence to AMA style guide, FDA/ICH regulations, and company SOPs.

Qualifications & Skills

✔ Education:

• B.Sc. in Life Sciences + writing experience OR

• B.A. in English/Communications with medical/scientific expertise

• Preferred: M.Sc., B.Pharm, or M.Pharm
  ✔ Experience: 3+ years in medical writing, including independent CSR authoring & QC review.
  ✔ Skills:

• Expertise in AMA style, FDA/ICH guidelines, and clinical research principles

• Proficiency in Microsoft Word, Excel, PowerPoint

• Strong analytical, proofreading, and communication skills

How to Apply

1. Apply online at Syneos Health Careers (Job ID: 25000321).

2. HR Review: Eligible candidates will be contacted.

3. Interviews: Virtual or in-person discussions.

4. Offer: Final selection & onboarding.

Don’t meet all criteria? Apply anyway! Transferable skills may qualify you.

Commitment to Diversity & Inclusion

Syneos Health is an equal opportunity employer. We welcome applicants regardless of race, gender, religion, disability, or veteran status and provide reasonable accommodations per the Americans with Disabilities Act.

Why This Role Matters

As a Medical Writer II, you’ll ensure regulatory-compliant, high-quality clinical documentation, directly influencing drug approvals and patient outcomes. Join us in Pune to advance global healthcare innovation!

🔗 Apply Now: Syneos Health Careers