Location(s): United States; Massachusetts; Marlborough
About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. Learn More About Careers at GE
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, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Role Summary: Provides legal support and strategic legal and compliance advice, guidance, and counsel on issues involving pharmaceutical research, development, and commercialization. Acting as a strategic business partner, this individual is expected to provide advice to the GE Healthcare Life Sciences Core Imaging USCAN business on opportunities, strategic direction, tactical matters, and risk management.
Support research, development, marketing, promotion, and commercialization of pharmaceutical products.
Draft, review, and negotiate strategic business agreements and transactions.
Advise the business on regulatory, privacy, antitrust, advertising/promotional, 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.
Manage outside counsel, when brought in to assist.
Manage/support the management of disputes, litigation, and incidents involving Core Imaging 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 Core Imaging’s global operations.
Advise on legal issues involving pharmaceutical research and development, including: • Preclinical and clinical research agreements for GE sponsored or funded project • 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 business team as a business partner to identify opportunities to drive business forward, e.g. working with business development in structuring, negotiating, due diligence, closing and integration of complex acquisitions and investments, to develop legal processes/ templates for new business, commercial models and clinical studies.
Support for business development activities focusing on agreements for co-development, co-promotion, and/or licensing projects
Coordinate with Senior Counsel, Life Sciences Core Imaging EMEA and regional counsel on global projects
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, including previous experience in drafting, negotiating and closing complex business transactions (i.e. purchase, sale and distribution agreements)
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
Experience in the Healthcare industry and previous exposure to healthcare industry regulations (FDA, Medicare/Medicaid anti-kickback)
Experience with the US False Claims Act
Demonstrated experience providing legal advice in a highly-regulated environment
Locations: United States; Massachusetts; Marlborough
We are in the process of transitioning to an improved job application system and in the interim we are operating with two systems. Have your Job ID ready (from the email you received when you applied) to log in and check your application status.
Click the appropriate button. If you don't know your job ID, you can still check your status: use both buttons.