Regulatory Writing Sr Mgr

Amgen UK

Base: $152,684.00 - $193,308.00 usd; bonus/equity:...
Fully remote
Doctorate degree with 2 years experience
Master's degree with 6 years experience
Bachelor's degree with 8 years experience
This role serves as the functional area lead on product teams to drive complex regulatory submission activities

Job Summary

  • This role serves as the functional area lead on product teams to drive complex regulatory submission activities.
  • The position requires leading the authoring and formal review of critical documents including Clinical Study Reports and Investigator Brochures.
  • Amgen offers a comprehensive benefits package including retirement plans, stock-based incentives, and flexible work models.

Matching Summary

This role serves as the functional area lead on product teams to drive complex regulatory submission activities.

Salary

Base: $152,684.00 - $193,308.00 USD; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives; Benefits: Comprehensive health, dental, vision, and retirement plan

Skills & Requirements

Must-have

  • Doctorate degree with 2 years experience
  • Master's degree with 6 years experience
  • Bachelor's degree with 8 years experience
  • Experience in medical writing biotech industry
  • Leading regulatory submission document authoring

Nice-to-have

  • Mentoring junior medical writers
  • Cross-departmental initiative leadership
  • Functional area expertise on product teams

Key Requirements

  • Doctorate or Master's degree with specific years of experience
  • 5+ years experience in medical writing within Biotech/Pharmaceutical
  • Direct experience with regulatory documents and submissions

Work Rights

Not specified

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