Associate Director, Medical Writing

IQVIA

Durham, United States
Medical writing strategy
Clinical development strategy
Regulatory submission documents
The Associate Director is a key leadership position responsible for determining and driving the medical writing strategy for one or more therapeutic areas within Clinical Development

Job Summary

  • The Associate Director is a key leadership position responsible for determining and driving the medical writing strategy for one or more therapeutic areas within Clinical Development.
  • He or she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analysing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency.
  • This role has global responsibilities with potential for global reports, participation in global teams and interaction with regulatory agencies in multiple regions.

Matching Summary

The Associate Director is a key leadership position responsible for determining and driving the medical writing strategy for one or more therapeutic areas within Clinical Development.

Skills & Requirements

Must-have

  • Medical writing strategy
  • Clinical development strategy
  • Regulatory submission documents
  • Messaging strategy development
  • Cross-functional team leadership

Nice-to-have

  • Global therapeutic area leadership
  • Lifecycle management
  • Vendor governance participation
  • Modern medical writing processes

Key Requirements

  • 8+ years medical writing experience
  • 3+ years supervisory experience
  • PhD or MD preferred
  • Experience with CTD format submissions
  • eTechnology knowledge for regulatory submissions

Work Rights

Not specified

Tailored Resume

Cover Letter