Legal leader providing strategic legal advice for GE HealthCare research and product development. Collaborating with teams on compliance and regulatory matters.
Responsibilities
Actively partner with Global Research and Development teams and business segment and technology teams, continually working to identify and structure strategic research and collaboration opportunities
Promote the strategic alignment of all proposed research and collaboration projects with the relevant product technology roadmap and identified strategic research needs
Lead and develop the company’s research and collaboration legal/compliance practice group
Drive cross-business, global and regional engagement, involvement and interaction among legal and compliance colleagues to maximize effectiveness of the global legal/compliance team
Consult with Medical Affairs, Clinical Affairs, senior business segment and technology/engineering leaders on legal and compliance issues surrounding company-sponsored and investigator-initiated research and collaboration proposals and engagements
Structure, draft, and negotiate complex research and collaboration arrangements and oversee outside counsel (as necessary)
Advise on legal and compliance matters including Good Clinical Practices (GCP), Fraud and Abuse, Foreign Corrupt Practices Act / Anti-Bribery & Anti-Corruption, Regulatory, Intellectual Property, Privacy and Data Protection, Antitrust and other issues that arise in the research and collaboration context
Take a leading role on Research topics with respect to government relations activities, trade associations and regulatory agency responses
Provide leadership in the research and collaboration strategic needs assessment and approval processes
Collaborate with the compliance organization to detect, assess and mitigate research and collaboration compliance risks; promote a culture of continuous improvement; support compliance investigations and research and collaboration compliance operating mechanisms.
Work across GE HealthCare to develop and deploy appropriate updates and training
Requirements
JD (or equivalent) with active bar membership
Minimum of 12 years of legal work experience, with at least 7 years of healthcare experience at a large law firm, corporate legal department, government agency or research organization, including previous experience drafting and negotiating research agreements
Well-versed in GCP principles, regulations for the protection of human subjects and other research regulations
Demonstrable experience operationalizing policies, helping enforce research compliance and driving culture change
Experience in advising the healthcare industry and previous exposure to medical industry regulations (health authority/regulatory, Medicare/Medicaid Anti-Kickback, Anti-Bribery, Privacy)
Previous experience in identifying and resolving legal issues quickly and effectively and ability to make on-the-spot risk calls
Proven global team leadership experience and ability to function as a senior member of a management team
Strong executive presence with outstanding interpersonal and teaming skills; able to work effectively at all levels of the organization
Excellent written and oral communication skills with the ability to communicate research and collaboration issues in an easy-to-understand manner; strong working knowledge of English.
Proven experience managing teams of direct and/or indirect reports
Highest level of ethics and integrity
Benefits
medical
dental
vision
paid time off
401(k) plan with employee and company contribution opportunities
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