Sr. Ctry Approval Spec

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

**Job Description**

Join Us as Senior Site Contract Specialist- Make an Impact at the Forefront of Innovation
The Senior Site Contract Specialist manages the preparation, negotiation and finalization of the contracts process. Liaises and establishes effective relationships with sites and internal functional teams. Ensures quality, objectivity and risk analysis in the efficient delivery of Investigator Contracts. The role may involve mentoring junior staff.

• Prepares, review and coordinates local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provides local regulatory strategy advice (MoH &/or EC) to internal clients.
• Develops and implements local submission strategy. Provides technical ex...