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!
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