Medical Writer II – QC of Regulatory Docs (Hybrid – Gurugram)
Join Syneos Health, a global biopharmaceutical powerhouse, as a Medical Writer II specializing in quality control (QC) of regulatory documents. This hybrid position based in Gurugram, India offers an exciting opportunity to work with global clients, ensure scientific accuracy in medical writing deliverables, and contribute to the advancement of clinical trials and regulatory submissions.
Key Responsibilities
Perform QC of regulatory documents including CSRs, IBs, protocols, amendments, etc.
Write, edit, and coordinate clinical and regulatory documents independently.
Ensure content clarity, consistency, format, and adherence to ICH E3, AMA style, and SOPs.
Review statistical outputs for accuracy and consistency.
Lead and manage internal and client document reviews.
Mentor junior medical writers and review peer work.
Conduct clinical literature searches and ensure copyright compliance.
Track hours and ensure deliverables stay within budget and timelines.
Perform other writing-related duties as assigned.
🔹 Required Skills & Qualifications
Bachelor's degree in life sciences, pharmacy, or related field; advanced degree preferred.
Minimum 2 years of experience in medical, scientific, or regulatory writing.
Familiarity with FDA, EMA, ICH-GCP, and medical publication guidelines.
Proficient in English grammar and writing; knowledge of AMA Manual of Style.
Experience with QC of regulatory documents (protocols, CSRs, IBs, etc.) highly desirable.
Strong attention to detail and ability to work independently or in teams.
Experience in CRO or biopharma environments preferred.
Perks & Benefits
Hybrid work flexibility (Gurugram-based)
Career development and growth support
Access to global clinical and regulatory teams
Total rewards and peer recognition programs
Inclusive and diverse work environment
Technical and therapeutic training programs
Company Description
Syneos Health is a leading global biopharmaceutical solutions organization operating in over 110 countries with 29,000 professionals. Known for delivering across the clinical development, regulatory, and commercial spectrum, Syneos Health accelerates drug development by translating scientific insights into impactful therapies.
Work Mode
Hybrid – Based in Gurugram, India
Call to Action
If you are a detail-driven regulatory writer passionate about scientific accuracy and clinical outcomes, apply today to join Syneos Health’s mission of transforming lives through clinical excellence.
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Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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