Associate Director, Assistant General Counsel - Clinical Trial Agreements
Flexion Therapeutics
Location: Remote
Time: 6 months ago
- 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
- Potentially supervise and direct activities of Paralegal(s), as well as outside counsel, to ensure efficient and accurate operations
- Other ad hoc analysis / projects as deemed appropriate
- 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.
- Proven ability to interpret and apply legal requirements to specific projects and agreements.
- Proven knowledge of corporate legal issues, particular to the pharmaceutical and/or biotech industry including contracts.
- Excellent written and verbal English communication skills.
- Demonstrated excellent organizational skills.
- Proven negotiation skills.
- Proven ability to manage multiple projects, set priorities and meet deadlines.
- Excellent skill level in MS Office including Word, Excel, and Outlook.
- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with Company match
- Employee Assistance Program
- Mental Health Resources
- Disability Coverage
- Life insurance
- Critical Illness and Accident Insurance
- 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
EEO Statement: Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law. At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.
Agency Disclaimer: Pacira Biosciences, Inc. (Hereafter, Pacira) does not accept unsolicited resumes from recruiters or employment agencies in response to the Pacira Careers page or a Pacira social media post. Pacira will not consider or agree to payment of any referral compensation or recruiter fee relating to unsolicited resumes. Pacira explicitly reserves the right to hire said candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Pacira.
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