Rena Watson
- Role
- Associate Director Global Medical Affairs at Lantheus
- Location
- Orlando, FL, US
- LinkedIn followers
- 500 followers
About Rena Watson
I bring over 20 years of clinical research and operations experience to execute the…
Experience
Associate Director Global Medical Affairs
Apr 2022 — Present
Brings project management and process expertise to execute Medical Affairs Strategic Plan to ensure alignment across multiple stakeholders. Develops, leads, and facilitates strategic planning in partnership with the Medical Director and Chief Medical Officer. Leads cross functional processes with Business Development, Global Regulatory Affairs and Global Clinical Supply, Logistic Operations, Compliance and Customer Service team to ensure overall compliance prior to the release or shipment of product. Serves as Global Regulatory Affairs liaison for all internal and helps prepare documentation for Sponsor regulatory submissions. Implements, and maintains policies and procedures that ensure GMA activities are executed in accordance with compliance requirements. Creates/updates relevant SOPs, working practices, and forms in collaboration with Subject Matter Experts. Tracks documents as needed, ensuring audit readiness. Serves as Global Medical Affairs main QMS administrator for the approval of all compliance documentation within the team. Serves as expert for Operational Excellence and key driver of process improvement within Global Medical Affairs. Leads departmental initiatives to support ongoing process improvement. Responsible for compliance and oversight of Purchase Request for Research Program Owns monthly accrual processes as well as reconciliation/close-out, overseeing proper data entry and reporting for all product lines. Provides oversight of clinical studies, monitoring overall study integrity and compliance. Member of the Research Review Committee that oversees all clinical studies and activities prior to the execution of agreement with Business Development. Created Global Medical Affairs SharePoint page to organize content to increase internal communication. Staff Oversight -4 staff members including 1 Senior Global Medical Affairs Manager and 2 Compliance Supply Managers
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