The Assistant General Counsel II (Research Institute) will provide advice regarding a wide range of regulatory and transactional matters related to innovative medical research in an academic medical center. The lawyer’s work will include:
Serving as a legal resource for legal matters arising from the Research Institute, and providing support on compliance, patient, regulatory and other matters.
-Negotiating complex agreements related to data use, material transfer, manufacturing, clinical trials, collaborative research, clinical trials, and intellectual property licensing.
-Assisting in investigations regarding research integrity and other matters. Assist in drafting and updating policies.
-Advising institutional review board and other internal regulatory committees regarding relevant federal and local laws.
-Supporting biomedical research enterprise in interpreting government rules and regulations and assist in communications with government agencies.
Areas of focus to include research grants and contracts, research regulatory matters, data use, investigational products, manufacturing products for research, conflicts of interest, intellectual property, and technology transfer.
The ideal candidate would have the following experience:
- Reviewing, negotiating, drafting (from scratch as needed) and/or editing contracts and contractual provisions relating to biomedical research, such as intellectual property licensing, clinical trials, data use, sponsored research, material transfer, manufacturing and others.
- Counseling clients on regulatory requirements governing medical research and advising on scientific integrity investigations.
- Drafting, editing and/or reviewing other documents in addition to contracts, such as policies, consent forms, press releases, reports and others.
- General transactional, life sciences and/or academic medical center experience a plus.
- Provide legal guidance and advice to hospital leaders and other internal stakeholders on legal issues that arise in the health care setting.
- Work collaboratively as part of the Office of General Counsel and with clinical, administrative and research leaders throughout the organization in identifying and developing proactive and creative solutions to legal issues.
- Remain current on legal developments in areas of expertise and assist organization in responding to changes in laws/regulations/legal risks.
- Provide on-call legal services for urgent and emergent hospital legal matters arising outside of traditional business hours.
- Prepare and present trainings to internal stakeholders on relevant legal issues.
- Assign, oversee and actively manage the work of outside counsel in appropriate matters.
Required Licenses, Certifications, Registrations
License to practice law in the Commonwealth of Pennsylvania or, if licensed in another state, must obtain license to practice law in Pennsylvania within the first year of placement into position.
Required Education and Experience
Juris Doctor degree from an ABA accredited law school. A minimum of 3 to 5 years of relevant employment as an attorney.
Additional Technical Requirements
This position requires a demonstrated capability for legal research, analysis and reasoning, strong oral and written communication skills, an ability to identify and resolve complicated and sensitive problems creatively and with professional discretion and an ability to interact and function effectively in a competitive, professional healthcare, academic and research environment. Additionally, applicants must have excellent academic credentials, a strong work ethic, and strong interpersonal skills.