Senior Medical Writer – Project Management Experience – Hybrid, Gurugram, India
Location: Gurugram, India (Hybrid Work Model)
Salary: Competitive, experience-based compensation, typically in the range of ₹15,00,000 – ₹28,00,000 annually, plus performance-linked incentives.
Syneos Health is seeking a Senior Medical Writer with strong project management experience to lead the creation, review, and delivery of high-quality clinical and regulatory documents for global pharmaceutical and biotechnology clients. This hybrid role offers an opportunity to combine scientific expertise, regulatory knowledge, and leadership skills in a collaborative and growth-focused environment.
Key Responsibilities:
Lead the preparation and delivery of regulatory, clinical, and scientific documents including clinical study reports, protocols, amendments, investigator brochures, plain language summaries, periodic safety update reports, and NDA/eCTD submissions.
Mentor and manage less experienced medical writers on complex projects.
Coordinate medical writing activities across functional teams to ensure timelines, quality, and compliance with SOPs, client standards, and ICH guidelines.
Compile, write, and edit medical writing deliverables such as SOPs, training guides, and process maps using tools like MS Visio.
Review statistical analysis plans, tables, figures, and listings for content accuracy, grammar, and format.
Perform systematic literature searches and summarize findings for clinical and regulatory purposes.
Ensure adherence to AMA style, FDA, EMA, and ICH regulatory requirements.
Collaborate with clinical, data management, biostatistics, regulatory affairs, and medical affairs teams.
Maintain awareness of budget specifications and manage project hours efficiently.
Required Skills & Qualifications:
Bachelor’s degree in Life Sciences, Medicine, Pharmacy, English, or Communications with strong medical and regulatory knowledge.
Minimum 5 years of experience in medical writing with proven project management expertise.
Strong leadership skills with prior experience in team handling.
Excellent English grammar skills and familiarity with AMA style guide.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and MS Visio or equivalent tools.
In-depth understanding of ICH-GCP, regulatory submission processes, and clinical research principles.
Ability to interpret and present complex clinical data clearly and accurately.
Strong communication, presentation, and proofreading skills.
Perks & Benefits:
Hybrid work flexibility (Gurugram office + remote days).
Competitive compensation package with annual performance bonuses.
Opportunities for career growth in a leading global biopharmaceutical solutions provider.
Comprehensive training in therapeutic areas and regulatory requirements.
Inclusive work culture with peer recognition and rewards programs.
About Syneos Health
Syneos Health® is the only fully integrated biopharmaceutical solutions organization, accelerating the delivery of medicines to patients through a unique combination of clinical, medical affairs, and commercial capabilities. With over 29,000 employees in 110 countries, we have supported 94% of novel FDA drug approvals in the past five years.
Work Mode: Hybrid – Gurugram, India
Join Syneos Health and bring your medical writing and project leadership skills to high-impact global clinical programs. Apply now to make a meaningful difference in patient outcomes.
Gujarat :
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Siliguri |Illinois :
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