Associate Director, Assistant General Counsel - Clinical Trial Agreements
Flexion Therapeutics
Location: Remote
Time: 5 months ago
Description
About Pacira
Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients. Our in-depth knowledge of non-opioid pain management, coupled with our passion for advancing patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results.
Why work with us?
Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking - a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.
Summary:
This position provides legal expertise and support across all business functions within Pacira BioSciences, Inc., 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 Pacira 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.
Essential Duties & Responsibilities:
The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.
- 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
Education and Experience:
- 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.
Supervisory Responsibilities:
Depending on experience of the candidate, this position will potentially manage one or more paralegals.
Interaction:
The incumbent works closely with employees in all functional areas of the company to provide Legal guidance and support.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Knowledge, Skills, and Abilities:
- 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.
Physical Demands:
Ability to safely navigate and work in office environment consistent with pharmaceutical industry. Moderate noise level, work in cubicles. While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms, and stoop. Close vision and the need to focus on computer screen, use of hands, fingers, and wrist to type on keyboard and manipulate mouse.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Typical office setting, noise level is moderate with consistent printer, telephone ringing and conversation.
Benefits:
- 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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