Ctry Approval Assoc

Thermo Fisher Scientific UK

Competitive remuneration; annual incentive plan bo...
Local regulatory submission preparation
Ethical committee and moh knowledge
Site start-up activity coordination
The role involves preparing and coordinating local regulatory submissions including MoH and Ethical Committee approvals in alignment with global strategies

Job Summary

  • The role involves preparing and coordinating local regulatory submissions including MoH and Ethical Committee approvals in alignment with global strategies.
  • Candidates will serve as the key contact at the country level for submission-related activities and ensure alignment of site start-up timelines.
  • Thermo Fisher Scientific offers competitive remuneration, an annual incentive plan bonus, healthcare, and a culture based on integrity, intensity, involvement, and innovation.

Matching Summary

The role involves preparing and coordinating local regulatory submissions including MoH and Ethical Committee approvals in alignment with global strategies.

Salary

Competitive remuneration; Annual incentive plan bonus; Healthcare and employee benefits

Skills & Requirements

Must-have

  • local regulatory submission preparation
  • Ethical Committee and MoH knowledge
  • site start-up activity coordination
  • PPD tracking database maintenance
  • informed consent document development

Nice-to-have

  • experience with gene therapy approvals
  • ability to negotiate grant budgets
  • strong internal client communication skills
  • knowledge of decentralized clinical trials

Key Requirements

  • understanding of PPD SOPs and client directives
  • knowledge of current regulatory guidelines
  • accuracy in maintaining trial status databases

Work Rights

Not specified

Tailored Resume

Cover Letter