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Senior Medical Writer (Project Mgt Exp)

2+ years
15,00,000 – ₹28,00,000 annually
10 Aug. 13, 2025
Job Description
Job Type: Hybrid Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.