Corporate - Contract Law Attorney in Durham, NC

In-House

Durham, NC

Corporate - Contract Law Attorney in Durham, NC

Attorney

Min 10 yrs required

No

Job Title: Head of Legal and Compliance, North America

Job Responsibilities:

The Head of Legal and Compliance, North America at the company is a pivotal role responsible for leading the Legal and Compliance department in North America. The primary responsibilities include:

- Serving as a trusted advisor to the North American commercial leadership team, providing legal and strategic advice on various non-intellectual property legal matters.
- Reviewing promotional materials and significant product-related communications to ensure compliance with legal and regulatory standards.
- Drafting, reviewing, and negotiating a wide range of contracts, including customer agreements, non-disclosure agreements, master service agreements, distribution agreements, and consultancy agreements. This also involves ensuring Fair Market Value assessments for bona fide service agreements.
- Developing contract templates and providing guidance on contract disputes.
- Liaising with the company’s headquarters in Denmark to support global and multinational contracts.
- Acting as the North American Compliance Officer, responsible for driving the North American Compliance Committee.
- Developing, implementing, and managing a risk-based compliance program by identifying and managing legal and compliance risks in the US and Canadian markets.
- Providing advice and training on the company’s legal and compliance policies and ensuring appropriate monitoring of compliance with these policies.
- Working closely with the Global Compliance department and the Chief Compliance Officer to align activities with the Global compliance program and handle related investigations in North America.
- Ensuring compliance with relevant laws and regulations, including US state sales and marketing laws, disclosure laws, anti-trust regulations, and data privacy laws.
- Collaborating closely with all functions within the North American organization, particularly the commercial team, and maintaining a strong relationship with the Global Legal and Compliance department and other internal stakeholders.
- Overseeing and managing outside counsel in North America.

Education and Experience Information:

- A Juris Doctor (.) degree from an accredited US law school.
- Membership in good standing with at least one US state Bar Association.
- A minimum of 10 years of experience in a law firm and/or in-house role is required.
- Direct experience in an in-house role within the biotech or pharmaceutical industry is essential.
- Experience with vaccines is preferred but not mandatory.
- Extensive knowledge and experience in pharmaceutical promotional materials regulations and review.
- Experience in reviewing and drafting agreements with Group Purchasing Organizations (GPOs) and commercial contracts.
- Experience advising on commercial and medical activities, regulatory matters, and compliance issues.
- Working knowledge and experience advising on laws and regulations governing the life sciences industry, including the False Claims Act, Anti-kickback Statute, FDCA, Title 21 of the Code of Federal Regulations, OIG Guidance(s), the PhRMA Code, privacy laws, competition laws, and other applicable laws and regulations.
- Ability to work both collaboratively and independently, with strong initiative, flexibility, and sound business judgment.
- Comfort working with different levels of the organization, including senior management, with the ability to set priorities and manage multiple demands.
- Strong communication skills, with the ability to balance detail-oriented and structured work with fast, pragmatic decision-making.

Salary Information:

The position offers a comprehensive benefits plan and a competitive compensation package, with a salary range of $230,000 to $290,000.

The company is an international organization specializing in innovative vaccine development, with a commitment to protecting lives through its market-leading products. It offers a dynamic and flexible work environment, opportunities for personal and academic development, and is committed to equal employment opportunities, ensuring non-discrimination based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.