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General Counsel Consulting

General Counsel
Consulting
provided
exceptional
service in helping
my organization
recruit for a hard
to fill position.
They did extensive
work on the front
end to understand
our needs and
our culture and
began referring
highly qualified
candidates almost
immediately.

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

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Counsel Jobs > Senior Corporate Counsel Job in New York > Senior Corporate Counsel

In House Legal Job Listings

YOUR WINDOW TO A WORLD OF OPPORTUNITIES

Senior Corporate Counsel

Refer job# WSKE150300

Senior Corporate Counsel (Commercial) The candidate will be responsible for: Provide advice, guidance and counsel to Commercial, Medical, Regulatory and other relevant functions on management and marketing strategies, product labeling, sales training and compensation, speaker programs, and policies, practices and initiatives with respect to compliance with relevant healthcare laws, guidance documents or opinions, and industry codes (FDCA, FDA guidance documents, Fraud and Abuse laws, Anti-kickback Statute, federal and state transparency laws, OIG Advisory Opinions, PhRMA Code, FCPA, etc.). Advise internal clients on projects, initiatives, and communications regarding products pending FDA approval. Represent the legal function in the review of advertising, promotional and educational materials submitted for review to BridgeBio's Promotional Review Committee. Drive the finalization and rollout of a robust healthcare compliance program across BridgeBio, including development and enhancement of policies and procedures, risk assessments, monitoring, training and compliance communications. Coordinate with Head of Legal Affairs and BridgeBio management to ensure alignment on and communication of appropriate decision making on compliance. Partner with the business to proactively identify and mitigate areas of potential risk. Provide legal and compliance training to field and home office personnel and external consultants. Review and provide legal guidance on financial and other interactions with healthcare professionals, patients, or others in a position to influence healthcare decisions (e.g., payers, advocacy groups, distributors, etc.) to ensure compliance with applicable laws and regulations. Work collaboratively with internal business clients on policies and procedures to ensure compliance with statutory and regulatory drug pricing and price reporting obligations under Medicaid, Medicare and the 340B program. Partner with internal business clients, colleagues across BridgeBio, and external counsel (as needed) to ensure programs meet established compliance standards Support company product launch initiatives. Provide guidance regarding reimbursement and coverage matters. Partner with commercial regulatory and others regarding state licensing and distribution strategy. Provide legal support for a range of activities associated with implementing patient assistance and support programs. Provide guidance regarding Risk Evaluation and Mitigation Strategy (REMS) obligations. Provide guidance regarding relevant privacy laws. Provide legal and compliance advice and collaborative support to strategic alliance partners in certain markets where commercial rights have been granted to third parties, including in Asia Pacific. Draft, review and negotiate various agreements in support of all the foregoing, including third party vendor agreements, service agreements, distribution agreements, consulting agreements and other corporate agreements. Liaise and coordinate with BridgeBio affiliates and subsidiaries to ensure consistency and generate efficiency. Proactively identify legal risks and work with other internal stakeholders to effectively eliminate or mitigate those risks while concurrently supporting business strategic goals. Must have J.D. degree from a nationally-recognized law school. Must have admitted to practice in the U.S., preferably in California, or ability to register in California as in-house counsel. Should have 12+ years as health law, life sciences or pharmaceutical compliance counsel either at a law firm, company and/or relevant government (e.g. FDA) agency. In-depth experience with the biotech or pharmaceutical industries, including business operations and regulatory framework. Should have experience with health care compliance and the rules and regulations concerning healthcare programs (including Medicare, Medicaid, 340B, etc.). Must have experience drafting, reviewing and negotiating a wide variety of commercial agreements.

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