Legal Counsel

Tris Pharma•Monmouth Junction, NJ

2d•$155 - $185•Hybrid

About The Position

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology. Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally importance to each team member is how we interact with one another. We believe in each other and in respectful, open and honest communications to help support individual and team success. We have an immediate opening at our Monmouth Junction, NJ offices for a Legal Counsel to join our small in-house Legal team. This role plays a crucial role in providing comprehensive legal guidance across business departments/functions and various aspects of business operations. Reporting directly to the Senior Vice President (SVP)/General Counsel Chief Compliance Officer (CCO), the incumbent serves as a cross-functional subject matter expert (SME), supporting Senior Leadership in strategic and risk aware decision-making, as well as ensuring compliance with regulatory requirements and company Standard Operating Procedures (SOPs), as appropriate.

Requirements

Juris Doctor (JD) degree from accredited law school, including bar admission within one or more U.S. state(s) and minimum 5 years legal experience in the pharmaceutical, biotechnology or related industry in positions of increasing strategic and leadership responsibility REQUIRED
Excellent understanding and experience working with transactions, laws and regulations associated with development, manufacture, marketing and sale of pharmaceutical products REQUIRED
Current, hands-on experience drafting, reviewing, negotiating, and executing a wide variety of transactional and legal documents (i.e., master services agreements, confidentiality agreements, drug distribution, supply, commercial agreements, market access, clinical trials, pricing and reimbursement, etc.) REQUIRED
Strong working knowledge of, and/or direct exposure to, pharmaceutical business functions such as Compliance, Regulatory Affairs, Government Affairs, Commercial Operations, HR and Finance REQUIRED
Ability to influence without direct authority REQUIRED
We are a HYBRID work environment requiring local candidates to be able to work majority of week in our NJ office. Non-local candidates must be able to come into office multiple times a month.

Responsibilities

Reviews, negotiates and drafts a diverse array of commercial contracts (i.e., licensing, co-development, manufacturing and supply, distribution agreements, clinical trial, partnership agreements, etc.)
Collaborates closely with internal stakeholders to gather specifications and key business terms necessary for effective contract negotiations
Provides strategic legal advice on a wide range of legal issues, analyzing legal risks associated with business transactions, clinical research activities and product commercialization
Offers guidance on matters subject to disputes and ensures alignment with corporate objectives
Supports contract management by developing and maintaining contract templates to streamline contracting process, enhancing efficiency and consistency in contract administration
Successfully collaborates with external customers and internal clients regarding contract development, negotiations and disputes
Supports regulatory submissions and communications with various regulatory authorities (i.e., FDA), new product launches, pricing/rebate analysis, drug price reporting, reimbursement activities and commercial/research publications (i.e., healthcare economic material, etc.)
Stays current on laws and regulations impacting the pharmaceutical and healthcare industries, advises on legal rights under contracts, compliance requirements and regulatory submissions, as needed
Collaborates with internal stakeholders to ensure adherence to local, state and federal laws and regulations
Develops and administers training programs to internal clients on transactional and regulatory matters and industry best practices empowering stakeholders with knowledge and skills necessary to effectively navigate legal issues
Collaborates with internal departments including, but not limited to: Commercial, Finance, Human Resources (HR), Regulatory Affairs and Compliance, to provide legal guidance and support on laws, regulations, standard operating procedures and company policies affecting business
Works closely with outside counsel, as needed
Proactively assesses legal risks and provides guidance to executive leadership and business teams, contributing to informed decision-making and mitigating potential liabilities
Independently creates legal documents for departmental and internal client use

Benefits

full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups

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