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Global Regulatory Writing Manager

Amgen·Hyderabad

Pay not statedMid levelFull-time

Read from the company's own careers page; you apply on their site.

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About the role

Let’s change the world. In this vital role you will maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision) writing activities for product submissions, train and mentor more junior writers, and assist with departmental activities.

What you'll do

  • Conduct the formal review and approval of authored documents, following applicable standard operating procedures
  • With considerable supervision, manage regulatory writing activities for product submissions
  • Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
  • May provide functional area input for Global Regulatory Plan and team goals

What you need

  • Writing
  • SOP writing
  • Any graduate

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