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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, Commercial Brands (Senior Director level) Job in California > Senior Corporate Counsel, Commercial Brands (Senior Director level)

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Senior Corporate Counsel, Commercial Brands (Senior Director level)

Refer job# YTQQ157280

Senior Corporate Counsel, Commercial Brands (Senior Director level) Duties: Provide advice, guidance and counsel to internal brand teams regarding advertising and promotion, sales and marketing initiatives, compliance rules and regulations, FDA and OIG guidance documents, and industry codes (e.g. PhRMA) as they relate to business activities and communications with healthcare professionals and/or patients or patient advocacy organizations. Provide advice, guidance and counsel to commercial, medical and corporate teams on management and marketing strategies, programs, 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, FCPA, etc.). Serve as the legal representative on cross-functional Promotional Review Committees to provide legal feedback and direction on advertising, promotional and educational materials submitted for review. Provide legal advice and lead the negotiation and drafting of contracts for the Market Access team. Provide legal analysis and risk-based recommendations regarding the compliance rules and regulations (e.g., advertising & promotion, fraud & abuse, anti-kickback, privacy, and false claims act statutes) implicated by proposed or existing business strategies. Review and analyze advertising and promotional initiatives, pipeline products/clinical trial recruitment materials, grants/donations and sponsorships, and related research on FDA/OIG enforcement activities. Work with internal functional areas to identify, analyze, and mitigate risks, and also support the development, implementation, and maintenance of healthcare compliance & ethics programs, including counseling and training on compliance policies and healthcare compliance regulations. Provide analysis, guidance, and support to members of the Medical Affairs department, including Medical Directors, Medical Information, and Medical Science Liaisons. Provide analysis, guidance, and support on patient advocacy matters. Assist with periodic compliance risk assessments and resulting work plans. Assist in the creation of training plans and training modules in connection with compliance policies, including new hire orientation, anti-bribery and anti-corruption program, privacy, and promotional regulations. Present training to business units as needed. Provide counsel on laws applicable to pharmaceutical promotion and sales, PhRMA code and promotional practices, risk management and mitigation and general negotiating and contracting on managed care contracting support. 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. Assist with investigations of alleged violations of compliance policies, laws, regulations, or procedures. Develop and implement corrective action plans where compliance violations have been established. Supervise the activities of the Corporate Counsel, Commercial Brands and manage outside counsel as needed. Qualifications: JD and an active license to practice law is required. 8+ years of relevant experience in the biotech/pharma or healthcare industry. In-house experience is required. Additional experience at a regulatory agency or major law firm is also welcome. Significant experience supporting branded pharmaceutical products as cross-functional legal lead, including participation in promotional and medical review processes. Strong knowledge of the legal/compliance framework affecting the pharmaceutical/biotechnology industry, including sales and marketing, fraud and abuse issues, OIG and other industry guidance documents and issues arising under the Anti-Kickback Statute and the False Claims Act. Experience drafting and negotiating pharmaceutical commercial contracts (including payor and distribution agreements) preferred. Proven ability to assess, calibrate and effectively communicate legal risks to senior management and others within the organization. Ability to work with a high degree of autonomy and collaborate cross-functionally in a constantly changing, fast-paced environment with multiple competing deadlines. Accountability, sound judgment, and the ability to take ownership of an issue and recognize the business impact of legal advice. Ability to think creatively, devise practical solutions to challenging problems and effectively drive legal and business issues to closure. Strong leadership skills, high integrity and results focused, anticipating business needs and proactively managing time and direct report's time to effectively balance priorities.

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