RESEARCH COMPLIANCE ASSISTANT GENERAL COUNSEL I-CLINICAL TRIALS
: Job Details :

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.