Global Sr. Counsel, MSA & QARA

Job Description

Serves as a principal assistant to the Global Head of Legal - Regulatory, Quality, Medical & Scientific Affairs. Responsible for management of the delivery of legal services to support, globally, business operations and functional areas for Medical & Scientific Affairs (MSA) and Quality Assurance & 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 & QARA matters for all business units, worldwide, delegated by the Global Head of Legal - Regulatory, Quality, Medical & 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 & 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 - Regulatory, Quality, Medical & Scientific Affairs.

Job Qualifications

Required:

• J.D. degree from an accredited law school is required. Active license to practice law in the U.S. and good standing with the bar is required.
• Minimum of 10 - 20 years’ experience in healthcare law and regulation, preferably with medical devices.
• Other Considerations (travel/hours availability, etc.): Position is remote, with expected travel to Japan, EU and China approximately 5 -15%.

Preferred:

• Must possess the ability to collaborate with business leaders to understand their needs as they relate to legal issues. 
• Must be able to work in partnership with Compliance, Audit and other Legal colleagues. Must be comfortable having to provide clear, ethical and compliant guidance to regional business centers that are part of a global organization.
• Must possess excellent written and verbal communication skills, including the ability to communicate concisely with clients, to integrate legal and business knowledge and to provide balanced advice regarding regulatory risks.
• Demonstrated ability to create, review and work with a wide range of healthcare related legal and compliance activities. 
• Key internal relationships that are desired include: MSA and QARA personnel worldwide as well as Olympus’s Compliance and Legal Departments.