US Counsel

Key responsabilities :

• Review, draft, and negotiate day-to-day Company agreements, including, without limitation, master service agreements, statements of work, confidentiality agreements, consulting agreements, and sponsorship agreements.
• Review and draft documentation related to conduct of Company’s global clinical trials, including, without limitation, negotiation of clinical site confidentiality agreements and clinical trial agreements.
• Provide legal support and advice regarding health care fraud and abuse matters including Anti-Kickback Statute and False Claims Act matters.
• Serve a legal representative on U.S. Medical, Legal, Regulatory review committees for external-facing medical and commercial materials.
• Assist in implementation and maintenance of policies and procedures in support of Company’s compliance program.
• Assist with Company’s U.S. reporting obligations as a publicly traded company.
• Collaborate with other Legal and Compliance colleagues to provide legal support to the Company.

Location : Warren, NJ Office - On site 3 days a week

Qualifications :

• Juris Doctor from an accredited U.S. law school.
• Admission to practice law in good standing in at least one U.S. jurisdiction (preferably New Jersey).
• Minimum 5+ years of relevant legal experience in a law firm or in-house with a biotech or pharmaceutical company.

• Experience drafting, reviewing, and negotiating contracts.
• Ability to think critically, proactively identify issues, and offer pragmatic, actionable solutions.
• Manage multiple projects, set priorities, and meet deadlines.
• Engage effectively with cross-functional teams across multiple time zones and locations.
• Understanding of the U.S. legal and regulatory requirements applicable to the biotech and pharmaceutical industry (preferred).

Experience in counseling on U.S. FDA promotional regulations and with promotional review, including participating in promotional review committees or equivalent for pharmaceutical/biotech company (plus).

Behavioral skills :

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,
• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,
• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,
• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.

The compensation range for this role is $$ 175-200K - Bonus 20%