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Manager Document Coordinator

Merck Kgaa
Merck KGaA
12+ years
Not Disclosed
10 Sept. 17, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Manager – Document Coordinator

📍 Location: Bangalore, Karnataka, India
🆔 Job ID: 291606
💼 Job Type: Full-time


About Us

At our organization, we believe in working your magic. Our global teams innovate with science and technology to improve lives across Healthcare, Life Science, and Electronics.

  • Purpose in Healthcare: United As One for Patients – creating, improving, and prolonging lives.

  • Therapeutic Focus: Oncology, Neurology, Fertility, and medical technologies.

  • Global Presence: Teams working across 6 continents.

  • Culture: Inclusive, diverse, and flexible – offering opportunities for personal growth and global career advancement.


Role Overview

As a Senior Manager – Document Coordinator, you will support the Global Medical Writing Team in delivering its portfolio effectively and efficiently. You will demonstrate leadership in a matrix organization, guiding both the R&D Hub team in India and the global Medical Writing team, while driving innovation, compliance, and best practices.


Key Responsibilities

  • Independently oversee and conduct quality reviews of clinical and regulatory documents, including:

    • Protocols

    • Clinical Study Reports

    • Briefing Books

    • Investigator Brochures

    • Clinical Summary documents

  • Allocate and prioritize quality check and compliance activities.

  • Represent the QC team in meetings with internal and external stakeholders.

  • Lead and motivate the Clinical Medical Writing team in Bangalore.

  • Mentor and train new joiners/junior Document Coordinators.

  • Participate in meetings related to key MW, QC, and compliance activities.

  • Collaborate cross-functionally to continuously improve standards and best practices in medical writing.


Who You Are

Education

  • Graduate degree or equivalent job experience in Medical Writing.

  • Advanced science degree (MD/PhD) preferred.

Experience & Skills

  • 12+ years relevant experience in pharmaceutical/medical industry with strong scientific, safety, and regulatory knowledge.

  • Proven expertise in Medical Writing with knowledge of theories, principles, and concepts.

  • Strong command of written and spoken English (including medical terminology) and familiarity with the AMA style guide.

  • Experience in team leadership within QC: building teams, performance management, metrics, compliance, resourcing, and achieving KPIs.

  • In-depth knowledge of Clinical, Regulatory, and Safety documents.

  • Thorough understanding of ICH/GCP, CTD guidance, FDA regulations, and drug development processes.

  • Experience working with cross-functional, global teams and vendor resources across multiple time zones.

  • Flexible and adaptable attitude toward assignments and new learning.


What We Offer

  • A culture that values diverse perspectives and experiences.

  • Opportunities for growth, learning, and development at your own pace.

  • Commitment to innovation, inclusion, and belonging.

  • A chance to be part of a team dedicated to Sparking Discovery and Elevating Humanity.


Important Notice

⚠️ We are aware of fraudulent job offers made by third parties. Only trust official company communications. Please see our fraud prevention notice for details.


Application Process

  • If you applied before April 16, 2025, log into your old profile to check status.

  • For this and future applications, create a new applicant profile to track your progress.


Apply now and join us in shaping the future of healthcare with innovation and passion!