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Carrot Peelers, Sales, Personality and Your Job Search
In-House
Attorney
Min 10 yrs required
Senior Corporate Counsel, Commercial Brand Responsibilities 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 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. Lead the negotiation and drafting of contracts for the commercial and medical affairs groups. Work with internal functional areas to identify, analyze, and mitigate risks, and also support the development, implementation, and maintenance of global 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.
Qualification and Experience
Qualifications: JD required; undergraduate degree in the life sciences or related field preferred. 10+ years of relevant experience in biotech/pharma, healthcare, or the legal/compliance field. In-house experience is required. Additional experience at a regulatory agency or major law firm is also welcome. Experience with the legal/compliance framework affecting the pharmaceutical/biotechnology industry, including sales and marketing, fraud and abuse issues, OIG and other industry guidance documents, clinical trial regulations, and issues arising under the Anti-Kickback Statute and the False Claims Act. Strong technical background in the commercialization of pharmaceutical products in the US. Experience in materials review process, drafting and negotiating commercial contracts and pharmaceutical service and distribution agreements strongly preferred. Excellent interpersonal and client relation skills. Ability to work in a fast-paced environment with multiple competing deadlines, leveraging internal and external resources to meet those deadlines. Willingness to pitch-in and help on legal projects across the organization. Excellent research, writing, counseling and communication skills and a positive client service orientation. Ability to work independently, and as a team member, across the organization. Accountability, sound judgment, and the ability to take ownership of an issue and provide concise and timely advice. Ability to manage and serve a wide range of clients by recognizing and responding quickly and pragmatically to urgent situations. Ability to effectively triage a heavy workflow, setting appropriate priorities with clients and delivering results. Ability to coordinate activities across a large number of employees in various departments, throughout the company’s US, UK, and European locations. Ability to think creatively, devise solutions to challenging problems and effectively drive legal and business issues to closure.
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