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Melinda Burrows
Deputy General Counsel
- Litigation and
Compliance, Progress
Energy Service Company

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Associate General Counsel
Richmond Virginia United States

  Job Description Associate General Counsel, Legal   Job Family: Legal Job Title: Associate General Counsel ...

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Counsel Senior Corporate
Refer job# XAZC161166
Counsel Senior Corporate Duties: Conduct and oversee internal investigations. Consult on fraud & abuse and other legal issues. Manage litigation as necessary. Provide legal support, including FDA-related advice, analysis, and other job duties, to corporate functions, business units, and others as needed, including senior management and members of the Legal, Compliance & Communications and Government Affairs Departments, on legal issues affecting the Company and within the areas of responsibilities of the affected functions or business units. Identifying and resolving FDA-related issues relating to products and proposed business transactions, promotional and marketing reviews and advice, contract review / negotiations, advising on inspections, auditing for legal/regulatory exposures, advising regarding FDA premarket review, responding to enforcement issues, and, in general, providing advice and counsel to the Company on FDA-related issues. Provides general legal support in connection with business development (including acquisitions, investments, joint ventures and licensing transactions) and corporate finance transactions. Will be involved with the structuring, negotiating and documenting the transactions and advising clients on the transactions.

Qualifications: JD Preferred. 6 years experience as a practicing attorney in a generalist environment where there was a high level of transactional- focused work and success was dependent on building good relations with clients and required a customer service mentality. Knowledge of laws and procedures applicable to complex investigations, preferably in the health care area. Current and thorough knowledge of the Food, Drug & Cosmetic Act, associated regulations, FDA Guidances, and regulatory practices of the U. S. Food and Drug Administration in the regulation of medical devices. Knowledge of clinical laboratory law, regulations and legal issues is also desirable. Knowledge of genetics, pharmacognetics / pharmacogenomics, and / or FDA regulation of pharmaceuticals is also desirable.

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