Medical Writer II (Narrative Writing) – Syneos Health | Pune, India
Job Summary
Syneos Health is hiring a Medical Writer II (Narrative Writing) for its Pune office. The role involves authoring, QC, and editing clinical study reports (CSRs), safety narratives, protocols, and regulatory documents in compliance with ICH E3, FDA guidelines, and AMA Manual of Style. This is an excellent opportunity for professionals with 2+ years of medical writing experience in pharmaceutical, CRO, or biopharmaceutical environments to work on high-impact projects supporting global regulatory submissions.
Key Responsibilities
Author and edit CSR safety narratives, addressing review comments and ensuring timely delivery.
Prepare and finalize protocols, CSRs, patient narratives, annual reports, IBs, PSURs, plain-language summaries, manuscripts, and presentations.
Ensure compliance with ICH E3, FDA/ICH regulations, and company SOPs/templates.
Conduct quality and editorial reviews to ensure accuracy, consistency, and proper formatting.
Act as peer reviewer to ensure document clarity and scientific integrity.
Collaborate with cross-functional teams and resolve client feedback.
Review statistical analysis plans (SAPs) and provide content/format feedback.
Conduct clinical literature searches while adhering to copyright guidelines.
Mentor junior medical writers and maintain knowledge of regulatory best practices.
Monitor project budgets and timelines, ensuring delivery within allocated hours.
Required Skills & Qualifications
Bachelor’s degree in life sciences (Master’s or PhD preferred).
Minimum 2 years of experience in scientific, technical, or medical writing.
Experience with CSR narratives, protocols, and regulatory documents.
Familiarity with FDA, ICH guidelines, and good publication practices.
Strong English grammar skills and knowledge of AMA Manual of Style.
Experience in CRO, biopharmaceutical, or medical device industry preferred.
Ability to work independently in a deadline-driven environment.
Perks & Benefits
Competitive salary (specific range not mentioned in the description).
Career growth and professional development opportunities.
Technical and therapeutic area training and mentorship.
Inclusive and diverse work environment with recognition programs.
Comprehensive health benefits and work-life balance initiatives.
Company Description
Syneos Health is a global leader in biopharmaceutical solutions, delivering integrated clinical development, medical affairs, and commercial services. With 29,000 employees in 110 countries, Syneos Health partners with top pharmaceutical and biotech companies to accelerate drug development and regulatory success.
Work Mode: On-site / Hybrid – Pune, India
Call to Action
If you have strong expertise in narrative writing and regulatory medical writing, join Syneos Health and contribute to high-quality global submissions. Apply now to shape the future of healthcare innovation.
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