Specialist Document Coordinator_Quality Reviewer for Regulatory and Safety Documents

7 days ago

Bengaluru, Karnataka, India The businesses of Merck KGaA, Darmstadt, Germany Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Your Role:

As a Senior Associate/Specialist Document Coordinator, you will support the Global Medical Writing Team to deliver its portfolio effectively and efficiently. This role involves managing the quality review of clinical and regulatory documents Conducting quality review of clinical and regulatory documents, including Protocols, Clinical Study Reports, Briefing Books, Investigator Brochures, Clinical Summary documents, PBRER, DSUR, and RMP.

Who You Are:

Minimum Requirements:

  • A graduate or postgraduate degree in a relevant field such as BPharm, MPharm, BDS (Dental), BSc, MSc, MD, or PhD, or an equivalent combination of job experience.
  • Excellent written and spoken English, including medical terminology.
  • 2-5 years of experience in the pharmaceutical industry with relevant scientific and regulatory knowledge.
  • Knowledge of ICH/Good Clinical Practices, CTD guidance, and GVP guidance.

Preferred Requirements:

  • Conducting quality review of clinical and regulatory documents, including Protocols, Clinical Study Reports, Briefing Books, Investigator Brochures, Clinical Summary documents, PBRER, DSUR, and RMP.
  • Participating in meetings related to medical writing, quality control, and compliance activities.
  • Collaborating cross-functionally to continuously improve medical writing processes.
  • Familiarity with the AMA style guide.
  • A flexible attitude with respect to work assignments and new learning; readily adapt to changes.
  • Experience working within a team in a collaborative and supportive role.

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