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Medical Writer (CSR, IB, Protocol Drafting) – Syneos Health

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Syneos Health

Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related discipline (Master’s/PhD preferred).

Work From Home /Gurugram

3–5 years

Verified Job

Online Application
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Are you passionate about transforming clinical data into impactful scientific documents? Syneos Health, a global leader in biopharmaceutical solutions, is hiring for the position of Senior Medical Writer. This full-time opportunity is available in Gurugram (Hybrid) or Remote (India), offering you a chance to work on clinical study reports (CSR), investigator brochures (IB), and protocol drafting with a team that’s shaping the future of clinical research.

With over 29,000 professionals across 110 countries, Syneos Health integrates clinical development, medical affairs, and commercialization to accelerate life-saving therapies.


🧠 Key Responsibilities

As a Senior Medical Writer, you will:

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  • Lead the creation of clear, accurate, and compliant clinical documents, including CSRs, protocols, amendments, and investigator brochures.
  • Review and edit statistical outputs, ensuring clarity and consistency in data interpretation.
  • Collaborate across functions—data management, biostatistics, medical affairs, and regulatory teams.
  • Write and review documents following ICH E3, FDA, and global regulatory guidelines.
  • Mentor junior writers, perform quality checks, and ensure adherence to client and company SOPs.
  • Conduct clinical literature searches and ensure compliance with copyright standards.

🎓 Qualifications and Experience

  • Education: Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related discipline (Master’s/PhD preferred).
  • Experience: 3–5 years of relevant experience in medical writing, preferably in a biopharma or CRO environment.
  • Strong knowledge of FDA and ICH regulations, clinical research principles, and medical terminology.
  • Proficiency in MS Office, AMA Manual of Style, and project management tools.
  • Excellent written communication and peer-reviewing skills.

💼 Why Work with Syneos Health

  • Global exposure to high-impact clinical projects.
  • Supportive leadership, technical training, and career progression opportunities.
  • A culture built on authenticity, inclusivity, and professional growth.
  • Work on novel therapies — Syneos Health has collaborated on 94% of all novel FDA-approved drugs in the past five years.

📝 How to Apply

Eligible candidates can apply directly through the Syneos Health Careers Portal or send their updated CV to shalini.sen@syneoshealth.com with the subject line:
“Application for Senior Medical Writer – CSR, IB, Protocol Drafting”

Application Link

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