Global Regulatory Writing – Manager (safety Writing- Rmp/rems)

Amgen UK

Hyderabad, India
Extensive writing experience of rmp/rems
Excellent written/oral communication skills
Proficient time and project management skills
The role involves authoring and gaining approval of safety documents that comply with global regulatory standards

Job Summary

  • The role involves authoring and gaining approval of safety documents that comply with global regulatory standards.
  • You will maintain key business relationships with cross-functional product team members.
  • This position may also involve training and mentoring junior medical writers.

Matching Summary

The role involves authoring and gaining approval of safety documents that comply with global regulatory standards.

Skills & Requirements

Must-have

  • Extensive writing experience of RMP/REMS
  • Excellent written/oral communication skills
  • Proficient time and project management skills

Nice-to-have

  • In-depth knowledge of document management systems
  • Understanding of ICH and GCP guidelines

Key Requirements

  • Doctorate degree or Master's degree with 8+ years experience
  • Bachelor's degree with 10+ years experience

Work Rights

Not specified

Tailored Resume

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