General Electric Senior Counsel, Pharmaceutical Diagnostics in Marlborough, Massachusetts
Role Summary:Provides legal support and strategic legal and compliance advice, guidance, and counsel on issues involving pharmaceutical research, development, and commercialization in the USCAN Region. Acting as a strategic business partner, this individual is expected to provide advice to the GE Healthcare PDx USCAN business and its top management on opportunities, strategic direction, tactical matters, and risk management.
Essential Responsibilities:• Support research, development, marketing, promotion, and commercialization of pharmaceutical products.
• Draft, review, and negotiate strategic business agreements and transactions.
• Structuring, drafting, and negotiation of commercial contracts, sourcing and other agreements, as well as related transactional matters
• Advise the business on regulatory, privacy, antitrust, advertising/promotional, commercial, compliance and improper payments (eg. AKS, FCPA), matters.
• Provide regulatory and compliance advice and training, in conjunction with the Regulatory and Compliance specialist areas in GE Healthcare.
• Maintaining local commercial and compliance policies and procedures and ensuring consistent application of these throughout the PDx USCAN business, through sound partnering with the business.
• Manage outside counsel, when brought in to assist.
• Manage/support the management of disputes, litigation, and incidents involving PDx products.
• Apply combined business and legal judgment to proposed deals, relationships, and other issues requiring legal or compliance attention.
• Collaborate with regional legal colleagues and subject matters experts to analyze and advise the business on complex legal/compliance issues that arise out of PDx operations.
• Advise on legal and compliance issues involving pharmaceutical research and development, including:
•Preclinical and clinical research agreements for GE sponsored or funded projects
•Research compliance, e.g., registries and data transparency, patient rights, IRB interactions, informed consent
•Agreements with research service providers
•Collaboration and/or supply agreements with manufacturers of therapeutics
•Participate on cross-functional committees, e.g., grant funding
•Template development and management
• Work with the USCAN business team as a business partner to identify opportunities to drive business forward
• Support for business development activities focusing on agreements for co-development, co-promotion, and/or licensing projects
• Coordinate with Senior Counsel, PDx EMEA and regional counsels, as needed, on global projects
Qualifications/Requirements:• JD (or global equivalent) with active bar membership
• At least 8 years of relevant law experience at a large law firm or corporate legal department
• Previous exposure and relevant experience in the Pharma/Life Sciences/Healthcare sector with ability, experience, confidence and gravitas needed to advise the USCAN business at leadership level; previous exposure to healthcare/pharma industry regulations (FDA, Medicare/Medicaid anti-kickback)
• Demonstrated experience providing legal advice in a highly-regulated environment
Desired Characteristics:• Previous experience in identifying and resolving legal issues quickly and effectively and ability to make on the spot risk calls
• Previous experience prioritizing conflicting demands from multiple business clients in an extremely fast paced environment
• Ability to communicate using English; outstanding interpersonal skills
• Business acumen, ability to provide legal advice as part of cross-functional teams finding winning solutions as a team
• Experience with the US False Claims Act and in general with the typical compliance rules and regulations of the Pharma/Life Sciences/Healthcare sector in the region
• Previous experience and/or exposure to general healthcare/pharma compliance strongly preferred
About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.
Additional Eligibility Qualifications:GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).Additional Locations:United States;Massachusetts;Marlborough;