Provide oversight and guidance on laws and regulations that impact all aspects of R&D externalized engagements by promoting high standards of integrity, ethical behavior & legal compliance for R&D staff, key internal partners/customers and suppliers through:
• Implementation of the R&D third party risk assessment and management framework that addresses compliance-focused requirements impacting R&D when engaging with third parties
• Ensuring that all aspects of GSK’s compliance & procurement policies are adhered to and that risk mitigation plans are in place for the R&D area of outsourcing and academic engagement spend.
• Ensuring R&D staff, key internal partners/customers & suppliers are aware of their obligations with respect to all relevant policies, standards & regulations related to outsourcing and/or engaging third parties for contracts already executed.
• Lead the coordination of compliance and due diligence activities for R&D third party engagements as part of ensuring all pre-contract activities are completed prior to contract execution.
• Summarizing all TPR risks in scope of the engagement and providing a recommendation to the end user of actions to mitigate or manage the risk and ensuring appropriate signoffs.
• Coordinate risk management activities, CAPA entries and due diligence package archival by working with business owners, third parties and SMEs/key partners.
• Interfacing with existing R&D compliance/governance framework to escalate & address non-compliance issues and share best practice principles.
• As required, serve as liaison between GSK and external suppliers on compliance-related issues identified during due diligence; identify and proactively raise issues and concerns in a timely, open and appropriate manner and develop recommendations for resolution.
• Meticulous attention to detail & strong analytical abilities
• Strong organisational skills and advanced problem solving abilities
• The ability to work well under time pressure, multitask and carry out judgement-driven prioritisation with sustained high performance
• Well developed written and verbal communication skills, with the ability to build relationships at all levels, across many disciplines both internally and externally.
• At least 3 years’ experience within the Pharmaceutical Industry
• A basic understanding of Contract Management or Business/Proposal Development practice
• Bachelor's degree in Life Sciences, Business Administration or related discipline
• 1-2 years of experience of matrix management and/or project management.
Previous experience in one or more of the following disciplines (promoting quality approaches, behaviours and outputs): assurance, audit, compliance, project management, quality functions.
All profiles will be reviewed against the required skills and experience. Due to the high number of applications we will only be able to respond to successful applicants in the first instance. We thank you for your interest and the time taken to apply!
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