Medical Writer II (QC of Regulatory Documents) – Syneos Health | Pune, India
Job Summary
Syneos Health is seeking a Medical Writer II (QC of Regulatory Docs) in Pune, India, to quality check, author, edit, and coordinate high-impact regulatory and clinical documents—protocols, CSRs, IBs, narratives, PSURs, plain-language summaries, and publications. You will ensure scientific accuracy, consistency, style compliance (ICH E3, FDA, AMA Manual of Style), and on-time delivery while mentoring junior writers and partnering closely with cross‑functional clinical, biostatistics, and medical teams.
Key Responsibilities
Perform QC review of regulatory medical writing documents (protocols, protocol amendments, CSRs, IBs and updates, narratives, etc.).
Author, edit, and finalize a wide range of deliverables: protocols, CSRs, narratives, IBs, informed consents, PSURs, annual reports, manuscripts, abstracts, posters, presentations, plain language summaries.
Ensure compliance with ICH E3, FDA/ICH regulations, SOPs, client templates, authorship rules, and style/formatting guides.
Coordinate and lead document reviews; manage source documentation, track and resolve client comments.
Act as peer reviewer to ensure scientific integrity, clarity, grammar, format, and consistency.
Review SAPs and TFL specifications; provide feedback to refine statistical outputs.
Conduct online literature searches and ensure copyright compliance.
Mentor junior medical writers and share best practices.
Monitor timelines, hours, and budget adherence; communicate scope/status changes proactively.
Maintain strong working knowledge of drug development, regulatory guidelines, and industry best practices.
Complete administrative and compliance tasks within required timelines.
Required Skills & Qualifications
Bachelor’s degree in a relevant life science discipline (Master’s/PhD preferred).
≥2 years of experience in scientific/technical/medical writing (CRO, pharma, medical device preferred).
Demonstrated experience with QC of regulatory documents (protocols, CSRs, IBs, narratives, etc.).
Strong knowledge of FDA, ICH (including ICH E3) and good publication practices.
Excellent command of English and familiarity with the AMA Manual of Style.
Ability to synthesize complex clinical/statistical information and communicate clearly.
Proven ability to work independently in a deadline-driven, team-oriented environment.
Perks & Benefits
Competitive salary (range not disclosed in the JD).
Career development, progression pathways, and technical/therapeutic training.
Comprehensive health benefits and total rewards program.
Inclusive “Total Self” culture with strong focus on belonging and well-being.
Global exposure and opportunity to work on top-tier regulatory submissions.
Company Description
Syneos Health is a leading, fully integrated biopharmaceutical solutions organization with 29,000 employees across 110 countries. Syneos Health partners with the world’s leading life sciences companies to accelerate clinical development, medical affairs, and commercial success, bringing therapies to patients faster through agile, insight-driven execution.
Work Mode: On-site / Hybrid – Pune, India (as per business need)
Call to Action
Ready to elevate your medical writing & QC career with one of the world’s most respected biopharma partners? Apply now and help Syneos Health deliver scientifically robust, regulatory-compliant documents that impact patient lives globally.
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