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Director, Legal Affairs, Corporate and compliance Counsel
Refer job# DXQN170126
 
Director, Legal Affairs, Corporate and Compliance Counsel The candidate will provide comprehensive and high-quality legal and compliance counsel in the areas of commercial, sales, marketing, education/promotion, field sales & MSLs, and medical affairs activities for approved and pipeline products. Collaborate and counsel key stakeholders on a daily basis to ensure compliance with laws, regulations, and guidance, including the FFDCA, AKS, False Claims Act, HHS-OIG Guidance, FDA regulations and guidance, PhRMA Code, FMV, Aggregate Spend-Sunshine Act, etc. Routinely partner with senior management and the Vice President, Legal Affairs, Chief Compliance & Privacy Officer. Perform services to support and enhance Compliance Program and Enterprise Risk Management Program while fulfilling the Compliance Program's 7 Elements to advance the success and minimize risk. Assist, create, and provide training, SOPs/Policies, and business guidance. Optimize existing and implement additional auditing and monitoring plans and activities to provide oversight. Draft, review, and negotiate contracts in partnership with the Legal Contracts team. Perform special projects as assigned and demonstrate leadership ability on a wide range of topics.

The candidate should have a Juris Doctor from an accredited law school, with strong academic credentials. Licensed in good standing with at least one State Bar and having or able to obtain a CA corporate bar license. Should have 7 years of legal experience with at least 5 years (preferred) working as in-house counsel with a pharmaceutical/biotech company(ies). Experience with assisting in the creation and/or development of a pharmaceutical or device company compliance program. must have a deep understanding of healthcare laws as they relate to education, promotion, and distribution of prescription drugs. Broad knowledge of and significant legal and compliance program experience counseling and providing oversight for commercial and medical affairs functions and their activities. Experience reviewing promotional and educational materials, brand plans and other supporting documents for commercial and pipeline products, conducting product reviews, and advising on disease state education. Proven ability to think strategically about achieving corporate and product objectives by addressing the needs of internal and external stakeholders, and to analyze issues and propose options and recommendations. Must have strong communication and collaboration skills, be proactive, and be able to work independently in a fast-paced environment. Strong professional experience in a similar role within the pharmaceutical industry is preferred. Well-organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional teamwork environment. Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity. Strong interpersonal and organizational skills and excellent verbal and written communication skills are required. Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes. Ability to travel as needed - domestic and international.
 
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