IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.
Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Position Purpose :
The IQVIA Regulatory Intelligence service provides the pharmaceutical and medical device industries easy access to original and translated regulatory documents summarized regulatory intelligence and comparative tables with up-to-date key regulatory requirements worldwide.
In this role you will lead a team of 6 dedicated and experienced senior regulatory experts who together with the Content Manager are responsible for the quality of the regulatory intelligence delivered by the service.
In your role you will lead the content quality improvement projects as well as innovative content expansion projects. As the Content Lead you will collaborate closely with a broad network internal and external specialist working on active projects delivering clinical, regulatory or pharmacovigilance operations for pharmaceutical products and medical devices around the world.
Six direct reports.
Principle Accountabilities :
Overall Regulatory Intelligence Lead
Manage and lead a team of 6 senior regulatory experts located in multiple locations
Proactively scope, lead and successfully complete content developments projects by : Prioritize, scope and drive content improvement / enhancement projectsEvaluate resource and skill requirements to complete content development projectsWork in collaboration with the technical team to design and plan editorial processes and tools to maximize the delivery and quality to regulatory intelligence
Lead GxP validation efforts from a process and content perspective
Responsible for the Content Quality Management to meet quality targets as well as ensuring continuous improvement
Work with Content Production Manager to ensure production of high-quality regulatory intelligence
Experience and Skills Required :
Experience within Life Sciences in a leading role (preferably consultancy)
Knowledge of quality management within Life Sciences
In-depth knowledge of regulatory requirements within drug and / or medical device development
Demonstrated team leadership and mentoring skills
In-depth knowledge of IT systems used with regulatory, safety, clinical and quality (validated systems)
Experience in project management
Business understanding / acumen
Ability to create strong working relationships across the organization
Self-motivated, enthusiastic and hard-working
Strong analytical, organizational and problem-solving skills