Associate Director, Corporate Counsel - R&d Counsel Jobs in New_York - 155814 | Submit Resume | General Counsel Consulting
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Associate Director, Corporate Counsel - R&d
Refer job# SGCI155814
 
Associate Director, Corporate Counsel - R&D The counsel will provide legal support to the Research and Global Development teams supporting company's robust drug discovery pipeline. Provide advice and counsel on a wide range of legal and regulatory issues related to drug discovery and development. Serve as a proactive, solutions-oriented ethical counselor to internal teams. Provide advice and counsel to teams accountable for clinical studies across various therapeutic areas. Partner with Regulatory, Global Patient Safety and Global Clinical Development teams to ensure compliance with laws and regulations. Provide legal support to teams handling GCP non-compliance investigations. Serve as a subject matter authority on R&D matters within the Law Department and collaborating with other legal functions (e.g., Business Development and Contracting, Compliance, Litigation and Products/Regulatory Law group). Provide training to client groups on a variety of legal and regulatory issues.

The candidate must hold a JD with excellent law school credentials and 5 years of proven experience and a BA/BS degree. A license to practice law in New York or be eligible for licensure as a registered in-house counsel is required. Experience with regulations and laws impacting the Research and Development departments within the biopharmaceutical industry including ICH GCP, US FDA regulations (21 CFR) relating to clinical trials, GDPR and other privacy laws required. Working knowledge and understanding of the Food, Drug & Cosmetic Act, Anti-Kickback statute, Foreign Corrupt Practices Act a plus. Proficiency in drafting and optimizing Clinical Trial Agreements and Informed Consent Forms needed. An understanding of biopharmaceutical industry trends, legislative initiatives and their impact on company. Possess strong interpersonal skills, including diplomacy and flexibility, with the ability to communicate effectively across the organization with individuals at all levels of seniority. Have good judgment with the ability to maintain an objective perspective, particularly when determining the legal risk of clinical matters. Ability to act with resilience and patience while supporting a complex fast-growing clinical business required.
 
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