Research Compliance Assistant General Counsel I-clinical Trials

At Moffitt Cancer Center, we strive to be the leader in understanding the complexity of cancer and applying these insights to contribute to the prevention and cure of cancer. Our diverse team of over 9,000 are dedicated to serving our patients and creating a workspace where every individual is recognized and appreciated. For this reason, Moffitt has been recognized on the 2023 Forbes list of America's Best Large Employers and America's Best Employers for Women, Computerworld magazine's list of 100 Best Places to Work in Information Technology, DiversityInc Top Hospitals & Health Systems and continually named one of the Tampa Bay Time's Top Workplace. Additionally, Moffitt is proud to have earned the prestigious Magnet® designation in recognition of its nursing excellence.
Moffitt is a National Cancer Institute-designated Comprehensive Cancer Center based in Florida, and the leading cancer hospital in both Florida and the Southeast. We are a top 10 nationally ranked cancer center by Newsweek and have been nationally ranked by U.S. News & World Report since 1999.

Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer. Join our committed team and help shape the future we envision.

Summary

Position Highlights:

Legal Service:

The legal services portion of duties will be to provide legal advice and counsel to Moffitt management and staff regarding bio-medical focused research, intellectual property, grants, ethics and regulatory compliance, and related contracting. The Assistant General Counsel I will be responsible for, but not limited, to the following:

* Draft, present, negotiate and finalize contracts and agreements for various departments.

* Provide legal advice and identify risks and benefits of licensing intellectual property and commercialization of research activities, including related compliance and contracting.

* Directly support members of management to ensure that all vendors used by each department have an appropriately reviewed and executed agreement on file.

* Assist to protect Moffitt's legal interest and maintain its operations in compliance with applicable law.

* Provide hands-on legal counsel to all levels of management.

* Identify and analyze legal issues, draft key documents, present clear recommendation and assure legal compliance.

* Keep current on new and emerging laws and policy developments (e.g. life sciences, research, grant compliance and health care) impacting Moffitt's operations.

* Draft institutional policies in accordance with best practices and within the bounds of applicable laws and regulations.

* Receive and investigate inquiries and issues related to legal matters such as licensures, credentialing, insurance, contracts and Moffitt policies.

* Direct and participate in the research of state and federal legislation and administrative and court decisions; investigate legal problems and make recommendations.

* Provide other legal support as directed or as circumstances may require to support management and protect Moffitt's legal interests.

* Supervise and manage the legal work of in-house paralegals, attorneys as well as outside counsel in support of the OGC's legal and administrative functions.

The Ideal Candidate

• The legal services portion of duties will be to provide legal advice and counsel to Moffitt management and staff regarding bio-medical focused research, intellectual property, grants, ethics and regulatory compliance, and related contracting.


• Experience drafting and negotiating clinical trial agreements.

• Preference for experience in the following:
  
  
  
  
  • Experience leading complex transactions with healthcare and biotechnology industry partners (both startups and large corporations) as well as other academic medical centers that include highly negotiated business and legal terms essential to achieving Moffitt's strategic goals, including finance, use of facilities, technology transfer, and protection of intellectual property.
  
  
  • Strong working knowledge of the statutory and regulatory requirements that arise in human subject research.
  
  

Responsibilities:

• Provide legal advice and identify risks and benefits of licensing intellectual property and commercialization of research activities, including related compliance and contracting.


• Identify and analyze legal issues, drafting key documents, presenting clear recommendation and assuring legal compliance.


• Initiate routine meetings with departmental leaders to effectuate contract negotiation and regulatory compliance.


• Support contract management efforts of the VP/ Deputy General Counsel and EVP/ General Counsel.


• Prepare, review and negotiate other business transactions.


• Research and special projects assigned by the VP/ Deputy General Counsel and EVP/ General Counsel.

Credentials and Qualifications:

• Juris Doctor required. This individual must be licensed to practice law and have at least 6 years' experience practicing law.

** Must possess State Bar certification; however, does not necessarily have to be a Florida Bar Board Certificate.**

• Excellent negotiating, interpersonal, business, contract drafting, and writing skills are required with a minimum of 8 years of related compliance and/or transactional experience.


• Bachelor's degree in a relevant field is a plus.


• Life science or medical research experience preferred.


• Experience supervising and managing paralegals and support staff for maximum efficiency is preferred.

Equal Employment Opportunity

Moffitt Cancer Center is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran or disabled status. We seek candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence.

Reasonable Accommodation

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
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