7 Assistant General Counsel - Clinical Trials Jobs in Parsippany, NJ
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Assistant General Counsel - Clinical Trials
$131k-180k (estimate)
Full Time
2 Weeks Ago
TAL Healthcare is Hiring an Assistant General Counsel - Clinical Trials Near Parsippany, NJ
Job DescriptionOur client, a biotech company that is a leading provider of non-opioid pain management and regenerative health solutions, is hiring an Assistant General Counsel - Clinical Trial Agreements. This position provides legal expertise and support across all business functions with specific focus on clinical trials (Phases 1-4). The position will need to frequently interact with senior level staff, as well as other constituents within the company and externally to ensure complete alignment with respect to contract development, approval, and execution, particularly for clinical trials and related agreements. In addition, this position will assist with various projects, litigations, and investigations as needed.
Responsibilities
Responsibilities
- Manage the contracting function for various departments within the Company, including:
- Draft, review, and negotiate Clinical Trial Agreements, informed consent forms, site management agreements, and other related contracts.
- Draft contracts and provide substantive legal review of third-party contracts.
- Partner with business departments within the Company, including but not limited to Commercial, Marketing, Medical, Clinical, Business Development, Supply Operations and Research and Development regarding the drafting and negotiation of all agreements
- Work closely with Legal Department and business colleagues in preparing guidance and training materials to support the efficient and compliant negotiation of agreements in the United States and abroad
- Provide legal counsel on health care laws, including the Federal Anti-Kickback Statute, False Claims Act, and compliance with laws, regulations, industry standards, and Company policies, as well as other related health care legal obligations to all business departments within the Company
- Working closely with other Legal Department colleagues and Compliance professionals to provide consistent and efficient legal and compliance support to the Company in accordance with Pacira’s healthcare compliance policies and related laws, codes, and regulations to mitigate risk to the company
- Work closely with cross-functional teams supporting the business, including Clinical, Medical Affairs, Regulatory, Compliance, Finance, Procurement, Tax, and other business functions to facilitate consistent and efficient support for clinical trials
- Juris Doctorate degree from Accredited Law School is required.
- Admission to the N.J. State Bar or eligible to obtain a N.J. limited license for in-house counsel.
- Minimum of 5 years of major law firm or in-house experience. Experience representing pharmaceutical and/or biotech companies preferred.
- Demonstrated understanding of the U.S. Legal requirements related to the pharmaceutical industry.
- Strong grasp of relevant federal and state laws, regulations, rules, and guidance as well as industry codes and principles impacting pharmaceutical manufacturers, focused on drug labeling, drug advertising, fraud, and abuse (anti-kickback, off-label promotion), product liability, clinical trials, etc.
- Knowledge of enforcement landscape, including relevant industry investigations, litigation, and settlements.
- Experience drafting and negotiating contracts such as master service agreements, statements of work, confidentiality agreements, supply agreements, consulting agreements, clinical trial and related agreements, and other corporate pharmaceutical-related agreements is required.
- Must understand contract law and have effective communication and negotiation skills and the ability to influence and work collaboratively at all levels and across functions.
- Experience with clinical trial agreements and informed consent agreements preferred.
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with Company match
- Employee Assistance Program
- Mental Health Resources
- Life insurance and Disability
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave
- Inclusive culture that fosters collaboration, growth, and innovative thinking
Job Summary
JOB TYPE
Full Time
SALARY
$131k-180k (estimate)
POST DATE
06/09/2024
EXPIRATION DATE
07/05/2024
WEBSITE
talhealthcare.com
HEADQUARTERS
Mount Kisco, NY
SIZE
50 - 100
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