Associate Director Corporate Counsel

Profile

Associate Director, Corporate Counsel
The candidate will advise and counsel internal teams accountable for clinical studies across various therapeutic areas and the organization. Will partner with Regulatory and Global Patient Safety teams to ensure compliance with laws and regulations. Offering legal support to teams handling GCP non-compliance investigations. Serve as a subject matter expert on R&D matters within the Law Department and collaborate with other legal functions. Conduct training to client groups on a variety of legal and regulatory issues. Should have outstanding oral and written communication skills and presentation capabilities. Should have excellent interpersonal and conflict resolution skills and ability to work in a highly collaborative environment. Should have JD with 5+ years of proven experience. You are licensed to practice law in New York or eligible for licensure as a registered in-house counsel. Prior in-house healthcare/pharmaceutical and/or biotech experience is strongly preferred. We need someone who has significant experience in life sciences compliance trends, regulations and laws impacting the Research and Development departments within the biopharmaceutical industry. These include ICH GCP, US FDA regulations relating to clinical trials, GDPR and other privacy laws. A solid understanding of the Food, Drug & Cosmetic Act, Anti-Kickback stature, Foreign Corrupt Practice Act is a plus. We also need an attorney who is proficient in drafting and negotiation of Clinical Trial Agreements and Informed Consent Forms.

Company info

Sign Up Now - WashingtondcCrossing.com