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 reg... more details
Our 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:
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
Requirements:
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.
Benefits:
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
Salary: $150,000-$165,000. This includes a 20% bonus, $1,200 in RSU (Restricted Stock Options) and Equity. The salary range is not a guarantee. The actual salary will be based on qualifications, experience, and education and could fall outside of this range. If you are passionate about what you could accomplish in this role, we would love to hear from you! #LI-NB1
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