Regulatory Affairs Officer

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Job description

The Clinical Contract Associate works closely with the Clinical Operations project teams, R&D Service Providers, clinical sites and other R&D functional leaders across Clinical Operations, Procurement, Legal, Finance, Corporate Compliance to ensure appropriate contracts are in place for each of the GMA clinical trials.

Main missions: Under supervision

  • Draft, evaluate, negotiate, execute & archive Clinical trial/ Clinical project related contracts (MSA and complex contracts will remain under R&D Legal however, this position may provide support to R&D Legal review of MSA if requested)
  • Establish and maintain Service Provider relationships by serving as a single point of contact for contractual matters
  • Manage record keeping for all contract-related correspondence and documentation
  • Provide contract-related issue resolution, both internally and externally
  • Monitor and complete contract close-out, extension or renewal, as appropriate
  • Communicate contract-related information to all stakeholders
  • Works closely with R&D legal and global purchasing in addition to the study team leads within GMA

Educational and/or experience requirements :

  • Legal/paralegal background and experience with reviews of terms and conditions and standard legal language contained in laboratory's master or country specific clinical trial agreements.
  • You are comfortable in bridging between clinical operations teams, site contracting teams and legal teams.
  • Will suit individuals who have recently completed their law degree or have had <3 years’ experience reviewing clinical trial contracts in a Pharmaceutical or CRO environment. 
  • 3 years’ work experience reviewing standard terms and conditions/ legal approved standard clauses within contract templates and the variations in such clauses as may be needed to address country specific requirements
  • Experienced in negotiating with trial sites’ and service providers’ legal and / or contracting teams across international locations.
  •  Fluent in both French and English.

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