Corporate Counsel/Senior Corporate Counsel, Global Practice Group, Manufacturing Regulatory/Clinical Counsel Jobs in California - 136014 | Submit Resume | General Counsel Consulting
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Corporate Counsel/Senior Corporate Counsel, Global Practice Group, Manufacturing Regulatory/Clinical
Refer job# WCTW136014
 
Corporate Counsel/Senior Corporate Counsel, Global Practice Group, Manufacturing Regulatory/Clinical Development Duties: Providing strategic and tactical advice to the product technical regulatory and quality organizations to mitigate legal or enforcement risk associated with the manufacture, and release of products, including preparation for and response to inspections and related observations and interacting with global health authorities in connection with quality incident and product supply reporting obligations; Supporting the supply chain team in complying with regulatory requirements regarding the import/export of bulk supplies, finished products and related knowledge, raw materials and technology; Advising product lifecycle and development teams, clinical study managers, regulatory, medical affairs, and other clients on good clinical practice compliance, human subject recruitment and protection, clinical data maintenance and transmission, research and storage of human tissue samples, conflict of interest issues and policies, investigator financial disclosures, FDA regulatory submissions, label negotiations, privacy, data use, and other potential company obligations, liabilities and related risk mitigation; Providing advice, education, training and legal direction on healthcare fraud and abuse laws, antitrust, privacy and other laws impacting business operations and contractual relationships related to clinical research and development for small and large molecule biopharmaceutical products and diagnostics; Serving as lead legal counsel for global development programs involving innovative scientific initiatives with industry collaborators including pharmaceutical manufacturers, academic institutions, research collaborative groups, and government entities; Interpreting company policies and developing risk mitigation strategies relating to conducting clinical trials, providing funding for scientific research, data sharing, patient recruitment, anti-kickback rules, informed consent requirements, and privacy protections; Negotiating agreements and providing counsel regarding contracting with health care professionals, institutions, study sites, foundations, cooperative groups, and government entities; Educating clients and colleagues about enforcement trends and discrete legal issues, and assisting in structuring tactics and related contracts in compliance with applicable laws; and Collaborating with patent and transactional attorney colleagues to support clinical development issues, and develop playbooks and guidance documents to advance efficiency efforts. Other opportunities within the Healthcare Law Group may include: Advising teams involved in commercial marketing and promotion of FDA approved products for treatment of diseases in various therapeutic areas; Providing strategic guidance in connection with commercial business operations support services such as advisory board services, incentive compensation design, marketing analytics and field team training and education; Serving as legal counsel for activities related to developing medical research and communicating relevant scientific knowledge to healthcare professionals and payors with respect to FDA approved products; and Counseling on innovative pricing strategies and relationships with public and private payors, distributors, pharmacies, and other managed care entities.

The candidate must have a JD with Bar admission from a top tier law school, and relevant legal experience. 5-7 years for a Corporate Counsel and 8-15 years for a Senior Corporate Counsel at a law firm with a nationally-recognized FDA / Life Sciences practice or in a pharmaceutical or biotechnology company s law department, with a focus on counseling pharmaceutical and/or clinical clients on U.S. and international rules related to the promotion, clinical development, and manufacture of human medicines and companion diagnostics. Significant knowledge of enforcement trends, the Federal Food, Drug and Cosmetic Act and related regulations, the False Claims Act, and laws related to fraud and abuse in the pharmaceutical and biotech industries is essential, along with excellent oral and written communications skills. A demonstrated ability to deliver sound and concise legal advice in a solution-oriented manner and in the context of evolving business strategy. Contribute actively to the legal department by proactively developing opportunities to enhance practice group efficiency. Consistently support the need to meet strict compliance requirements, and effectively present to group audiences.
 
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