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Global Sr. Counsel, MSA and QARA
Location:
Center Valley, PA
Description:
Working Location:NATIONWIDE Workplace Flexibility:Field Are you looking for a company that cares about people's lives and health, including yours? Let's inspire healthier lives, together. Olympus, a leading medical technology company, has focused on making people's lives better for over 100 years. Our Purpose is to make people's lives healthier, safer, and more fulfilling. Our Core Values are reflected in all we do: Integrity : Empathy : Agility : Unity : Long:Term View We deliver on our purpose and our core values by staying True to Life. Job Description Serves as a principal assistant to the Global Head of Legal : Regulatory, Quality, Medical and Scientific Affairs. Responsible for management of the delivery of legal services to support, globally, business operations and functional areas for Medical and Scientific Affairs (MSA) and Quality Assurance and Regulatory Affairs (QARA) activities. Responsible for managing a broad range of complex legal issues and serving as a senior legal advisor, providing advice on areas of risk. Responsible for oversight of the legal matters for the company's global functional area and business units, worldwide, relating to MSA and QARA matters. Job Duties: Responsible for legal MSA and QARA matters for all business units, worldwide, delegated by the Global Head of Legal : Regulatory, Quality, Medical and Scientific Affairs, including the planning, organization and management of work activities relating to MSA and QARA activities.: Serves as primary lead and strategic legal partner to the Global MSA organization. Responsible for providing legal counsel to the Chief Medical Officer and his/her leadership team. Acts as a strategic legal partner to the Global MSA team. : Oversees the development and implementation of processes to ensure the most efficient and effective delivery and consumption of MSA and QARA legal services, while protecting the Company's risk profile.: Ensures compliance with the law and internal corporate policies inclusive of the Global and Regional Control Frameworks. Collaborates with key stakeholders to provide input on policies and to ensure that policies are properly considered and integrated into all MSA and QARA activities.: Works with MSA and QARA senior management to define and implement MSA and QARA strategy for the Corporation. Liaises with senior leadership to understand evolving MSA and QARA business issues. Responsible for updating the executive leadership on key legal risks and significant case/matter progress.: Takes a lead position in the Global Legal MSA and QARA group to standardize legal process in keeping with best practice. Monitor the external regulatory and enforcement environment to identify risks to the MSA and QARA leadership and its customer relationships.: Takes a lead position on the Global Product Recall Committee that assesses and determines if any field corrective actions are needed for Olympus products.: Support interactions and inspections with competent regulatory authorities, globally. Provide legal support for compliance with investigations, obligations and commitments made to the FDA and competent authorities in other regions.: Additional responsibilities will include independently handling highly visible essential projects for global senior leaders in MSA and QARA such as grant giving, publications, interactions and payments to HCPs, Health Economic and Market Access (HEMA) activities, including reimbursement coverage, formulary and other patient access activities, clinical trials, continuing medical education activities, medical device reporting, quality system regulations, manufacturing activities, product approvals, field corrective actions, recalls, quality assurance agreements, product submissions, establishment registrations, and premarket activities.: Performs all related duties as may be assigned from time to time by the Global Head of Legal : Regulat
Posted:
May 1 on Tip Top Job
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More About this Listing: Global Sr. Counsel, MSA and QARA
Global Sr. Counsel, MSA and QARA is a Social Services Counselor Job located in Center Valley PA. Find other listings like Global Sr. Counsel, MSA and QARA by searching Oodle for Social Services Counselor Jobs.
Global Sr. Counsel, MSA and QARA is a Social Services Counselor Job located in Center Valley PA. Find other listings like Global Sr. Counsel, MSA and QARA by searching Oodle for Social Services Counselor Jobs.