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Public, biopharmaceutical company is seeking an FDA Compliance & Regulatory Counsel to join its team. This position will be located at the company's headquarters in Manhattan. The company is focused on developing innovative medicines for unmet medical needs and has a deep clinical pipeline and a commercial operation with specialty pharmaceutical products.
This FDA Compliance & Regulatory Counsel is a Senior Director level role and it reports to the SVP, Deputy General Counsel. This attorney will handle a wide array of duties including advising on regulatory and compliance matters, reviewing and negotiating clinical and commercial contracts and pre- and post-marketing related documents. This attorney will support the commercial, clinical, corporate and R&D functions at the company.
Overall Areas of Expertise and Responsibilities:
Food, Drug and Cosmetic Act
Good Manufacturing Practices and Good Clinical Practices
Physicians Payments Sunshine Act
Regulation of clinical trials, human subject protection and manufacturing
Governmental Pricing Compliance
Prescription Drug Marketing Act
False Claims Statutes
Promotional and marketing materials review process
Patient Protection and Accountable Care Act
Qualified candidate must be admitted to (and in good standing with) the bar of at least one state or the District of Columbia of the United States of America. Qualified candidate must have a minimum of 3-5+ years of experience in FDA regulatory and compliance matters and health care law practice, with a focus on pharmaceutical and/or biotechnology products or product candidates. Experience is also required in providing counsel in the review of labeling materials and others aspects of regulatory strategy for product submissions.
The qualified candidate will have experience in the regulation of clinical trials, human subject protection and manufacturing. The successful candidate will have excellent strategic and analytical skills, strong communication and presentation skills, and the ability to work effectively both independently and on teams. This position requires approximately 10% travel.
Bachelor's Degree and JD required
at least 3-5+ years' experience practicing law
Experience in drug regulatory counseling and in working on pharmaceutical compliance and regulatory matters
Knowledge of healthcare law, including general principles of Medicare reimbursement programs, anti-fraud statutes and programs including the Medicare Fraud and Abuse (Anti-Kickback) Statute, False Claims Act and Physicians Payments Sunshine Act
Significant regulatory experience with a focus on the promotional review process and a strong understanding of the rules and regulations enforced by FDA and OPDP
Experience preparing clinical trial agreements, material transfer agreements, master services agreements, specialty pharmacy contracts and supply agreements
Working familiarity with license, distribution and confidentiality agreements
Strong analytical abilities and ability to work effectively under strict time constraints
Strong written and oral communication skills with the ability to interact well with people from various levels within the organization (including senior management) and across functional units (including commercial, clinical, corporate and R&D)
Ability to work on several projects at one time with good organizational skills and judgment
Working knowledge of federal and state employment law, tax law, general tort law and contract law as those relate to healthcare laws
Pharmaceutical regulatory, licensing and intellectual property experience preferred
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