Sr. Ctry Approval Spec

PPD (Thermo Fisher)

United Kingdom
Remote
Prepare and review regulatory submissions
Liaise with regulatory authorities
Negotiate investigator contracts
PPD (Thermo Fisher) is seeking a Senior Site Contract Specialist to manage contract processes and regulatory submissions, ensuring timely and efficient site activations. The ideal candidate will possess strong negotiation skills and the ability to build effective relationships with internal teams and external investigators

Job Summary

  • The Senior Site Contract Specialist manages the preparation, negotiation and finalization of the contracts process, liaising with sites and internal teams to ensure quality and risk analysis in the efficient delivery of Investigator Contracts.
  • The role involves preparing, reviewing, and coordinating local regulatory submissions, providing local regulatory strategy advice, and serving as the primary contact for investigators and local regulatory authorities.
  • Ensures guidelines and processes are followed for effective communication with internal teams, investigators, and country regulatory authorities to manage submissions in a timely manner and achieve target cycle times for site activations.

Matching Summary

Match Score: 85

PPD (Thermo Fisher) is seeking a Senior Site Contract Specialist to manage contract processes and regulatory submissions, ensuring timely and efficient site activations. The ideal candidate will possess strong negotiation skills and the ability to build effective relationships with internal teams and external investigators.

Skills & Requirements

Must-have

  • Prepare and review regulatory submissions
  • Liaise with regulatory authorities
  • Negotiate investigator contracts
  • Develop local submission strategy
  • Manage site start-up activities

Nice-to-have

  • Mentor junior staff
  • Proactive issue identification
  • Maintain knowledge of SOPs

Key Requirements

  • Experience in regulatory submissions
  • Contract negotiation skills
  • Knowledge of regulatory guidelines

Work Rights

Not specified

Tailored Resume

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