Sr. Ctry Approval Spec

PPD (Thermo Fisher)

UK
Prepare local regulatory submissions
Negotiate investigator contracts
Coordinate site start-up activities
The Senior Site Contract Specialist manages the preparation, negotiation, and finalization of contracts to ensure efficient delivery of Investigator Contracts

Job Summary

  • The Senior Site Contract Specialist manages the preparation, negotiation, and finalization of contracts to ensure efficient delivery of Investigator Contracts.
  • This role serves as the primary contact for investigators and local regulatory authorities to manage submissions in a timely manner.
  • The position requires developing and implementing local submission strategies while ensuring alignment with global project submission strategies.

Matching Summary

The Senior Site Contract Specialist manages the preparation, negotiation, and finalization of contracts to ensure efficient delivery of Investigator Contracts.

Skills & Requirements

Must-have

  • Prepare local regulatory submissions
  • Negotiate investigator contracts
  • Coordinate site start-up activities
  • Manage country regulatory authorities
  • Develop submission strategies

Nice-to-have

  • Mentoring junior staff members
  • Proactive issue resolution skills
  • Collaboration with internal teams

Key Requirements

  • Experience with MoH and EC regulatory processes
  • Knowledge of gene therapy approvals and viral safety dossiers
  • Understanding of PPD SOPs and client directives

Work Rights

Not specified

Tailored Resume

Cover Letter