Merck Hiring Principal Medical Writer

Merck Hiring Principal Medical Writer

27 April, 2022

As the Principal Medical Writer, you are a true leader who will support the Global Medical Writing Team to deliver its portfolio effectively and efficiently. You will demonstrate leadership skills in delivering in a matrix organization towards both, the team based in our R&D Hub in India and the global Medical Writing Team (support best practice, drive innovation, adhere to processes).

Your Role:

  • Independently oversee and write several clinical and regulatory documents (with a particular focus on IBs and IMPDs/INDs)
  • Thoroughly analyze and critically interpret data to determine the best approach to composing each document
  • Mentor and train the assigned new joiners/junior medical writers
  • Standardize processes, develop and maintain quality documents and related training materials
  • Participate in meetings related to key MW, QC, and compliance activities
  • Collaborate cross functionally for continuous improvement of standards and best practices for medical writing

Who you are:

  • Graduate degree or equivalent job experience with comprehensive Medical Writing knowledge of theories, principles and concepts, MD/PhD or advanced science degree.
  • Profound pharmaceutical industry experience (more than 10 years’ experience in a medical or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge) required.
  • In-depth knowledge of Clinical, Regulatory, and Safety documents
  • Ability to lead and manage the key activities including leading creation, coordination of the authoring functions, and facilitation of the review of the documents and ensuring that documents are submission-ready and finally approved
  • In-depth knowledge of ICH/Good Clinical Practices, CTD guidance, FDA regulations, and the drug development process.
  • Excellent written and spoken English (including medical terminology) and familiarity with AMA style guide.
  • Comprehensive experience in working with cross-functional, global teams, and vendor resources across different regions and time zones.
  • A flexible attitude with respect to work assignments and new learning; readily adapt to changes

Apply through this Link

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