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Years of Experience
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Corporate Counsel R&D The candidate will be responsible for supporting and advising clinical development, regulatory strategy, pharmacovigilance and other R&D clients on a broad array of issues relating to FDA pharmaceutical regulations, GxP requirements, product development, product labeling, interactions with healthcare professionals and patients, anti-trust, anti-kickback, competitor issues, compliance issues, regulatory policy and industry developments and issues. Responsible for coordinating with the Legal and Compliance Departmentâ€™s contracting team to support the contract needs of the R&D departments, as needed. Provides clear, actionable and business-savvy legal advice to clients within the R&D organization on matters pertaining to processes and procedures in support of clinical trials, cooperative studies and similar arrangements, with a particular emphasis on the relationships between and among sponsors, CROs, sites/investigators and vendors, as well as matters relating to regulatory strategy, pharmacovigilance, and other functions within the R&D organization. Provides strategic advice and counsels clients on the legal implications of research and development projects, regulatory matters, business development matters, healthcare compliance issues, and activities involving interactions with healthcare professionals, healthcare organizations, research institutions and patients. Serves as primary legal support on process and contractual matters relating to clinical trial disclosures and data sharing arrangements and provides input as needed on clinical trial transactional matters. Provides subject matter expertise, and legal support and guidance, on the development and application of standard operating procedures and related supporting procedural documents for R&D activities. Works as part of a matrix team at firm supporting the R&D departments, handling clinical, regulatory, quality and pharmacovigilance and drug safety matters. Advises clients on a broad range of legal and contractual matters to support firms global R&D business, including informed consent documents, correspondence with institutional review boards/ethics committees, advisory board and HCP engagements and other agreements. Assists with and supports legal and corporate due diligence activities on strategic transactions, as requested. Educates clients regarding relevant legal updates, industry and regulatory developments, industry best practices, and risk mitigation solutions. Works extensively and collaboratively with firm colleagues in Europe and the ex-U.S. business with respect to contract alignment and local compliance and disclosure requirements. Assists with supporting corporate compliance function; helps create and deliver policies, procedures and training to R&D teams. Drives increased efficiency, coordination, and effectiveness of legal advice, processes, and support to meet the needs of the R&D functions and the global business. Partners with Legal and Compliance Department colleagues in executing and enhancing corporate and department objectives.
Qualification and Experience
The candidate must have Juris Doctorate degree and admission to the Bar in one state and eligible to practice as in-house counsel in California or Pennsylvania. Should have 5-7 years' of experience supporting clients in the pharmaceutical industry, preferably at a multinational company and/or a reputable, highly rated law firm, or a combination of both, with a substantial amount of professional experience dedicated to advising on FDA regulatory compliance, Good Clinical Practice (GcP), and other matters relating to clinical trials and research and development activities.
Job ID: 2018-3629
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