Senior Specialist – Document Coordinator
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Company: Merck Group
Overview:
Merck is hiring a Senior Specialist – Document Coordinator to support the Global Medical Writing (MW) Team by ensuring high-quality delivery of clinical and regulatory documentation. This role requires a strong understanding of medical writing standards, document compliance, and regulatory knowledge to support the preparation and quality review of critical content within a global healthcare setting.
Key Responsibilities:
Conduct quality review of clinical and regulatory documents such as Protocols, Clinical Study Reports (CSRs), Investigator Brochures, Briefing Books, and Clinical Summaries
Mentor and train junior coordinators and new team members
Collaborate with cross-functional teams for continuous improvement in medical writing workflows and compliance
Participate in MW, QC, and compliance-related meetings
Ensure accuracy, consistency, and regulatory alignment of documents across deliverables
Candidate Profile:
Education: Graduate or Postgraduate in BPharm/MPharm, PhD, BDS, BSc/MSc or equivalent with relevant industry experience
Experience: 4–7 years of pharmaceutical/clinical/medical writing experience
Required Knowledge and Skills:
Deep understanding of medical writing principles, regulatory documentation, and ICH/GCP/CTD guidance
Strong familiarity with medical terminology and the AMA style guide
Excellent command of written and spoken English
Experience reviewing or preparing high-quality, submission-ready documents
Adaptable, team-oriented, and eager to embrace learning and change
Estimated Salary: ₹10–15 LPA (based on experience and role complexity)
Gujarat :
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