Head of Legal and Compliance, North America

Protecting our tomorrow

Protecting Our Tomorrow

At Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system. We are a global leader in smallpox/mpox vaccines, and our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, typhoid fever, and cholera. We excel in R&D innovation, manufacturing, and commercialization. We aim to improve health and quality of life for children and adults around the world – protecting our tomorrow. We hope that you will share this mission with us. 

Head of Legal & Compliance, North America

We are looking for an experienced and self-driven attorney for the position of Head of Legal & Compliance, North America, to become part of our Global Legal & Compliance department and to support our business in the US and Canada.

Note: This is a REMOTE position in the US (EST time zone preferred).

In this role, you will be heading up the Legal & Compliance department in NA (currently with one lawyer reporting into this role) and will be responsible for building a department with the ability to scale to meet the needs of the company as it expands its footprint within North America.

Your team is an integrated part of the company’s Global Legal & Compliance function, and you will report to the Group General Counsel, based in Hellerup, Denmark, who is also the Company’s Chief Compliance Officer. You will be responsible for supporting the company’s day-to-day operations in the US and Canada and will have the following key responsibilities.

Your Responsibilities

As the Head of Legal for NA, you will become a trusted advisor to the NA commercial leadership team and be responsible for all (non-IP) legal matters in the region, including providing legal and strategic advice to the NA commercial leadership team and other stakeholders in the company, reviewing promotional materials and other significant product-related communications, drafting and reviewing contracts across a range of commercial transactions, and providing advice to the NA organization on other legal, business, and regulatory issues, as needed.

Product Communication.

• You will be responsible for providing day-to-day advice regarding promotional materials, commercial communications, medical and scientific materials, disease awareness, and related activities for the company and its products
• You will be a member of the US promotional review committee, a multi-disciplinary team which includes Medical Affairs, Legal, Regulatory Affairs and Marketing. As the legal reviewer, you will identify issues that may raise legal concerns, propose compliant alternatives, and ensure promotional materials are on label and comply with the company’s policies and legal and regulatory requirements while achieving the company’s objectives

Drafting, Reviewing and Negotiating Contracts.

• You will review, draft, and negotiate various types of contracts including customer agreements (Group Purchasing Organizations, wholesalers and IDNs), non-disclosure agreements, master service agreements and statements of work, distribution agreements, consultancy agreements, and agreements with healthcare professionals, and you will ensure Fair Market Value assessments are performed for bona fide service agreements
• You will develop contract templates and provide legal guidance to the NA organization on contract disputes
• You will liaise with the company’s headquarters in Denmark to support on global and multinational contracts, as needed

Compliance and Risk Management

• In your role as NA Compliance Officer, you will be responsible for driving our NA Compliance Committee and for continuing the development, implementation, and management of a risk-based NA compliance program by identifying and managing legal & compliance risks on the US and Canadian markets, providing advice and training on the company’s legal and compliance policies, and ensuring appropriate monitoring of compliance with the policies
• You will work closely with the Global Compliance department and with the Chief Compliance Officer to align activities with the Global compliance program and to handle matters and investigations related to North America
• You will identify and ensure compliance with relevant laws and regulations applicable to the company and its NA business, such as US state sales & marketing laws/disclosure laws, anti-trust regulations and data privacy laws

Key Stakeholders  

• You will have close collaboration with all functions in the NA organization, in particular the NA commercial team, and will have close collaboration with the rest of the Global Legal & Compliance department (based in Denmark) as well as other internal stakeholders (based in or outside NA)
• You will oversee and manage outside counsel in NA

Skills & Requirements:

• J.D. from an accredited US law school, and a member, in good standing, of at least one US state Bar Association
• 10+ years of law firm and/or in-house experience required
• Direct experience in in-house role in biotech/pharma industry required
• Experience in vaccines is preferred but not a requirement
• Extensive knowledge and experience in pharmaceutical promotional materials regulations and review
• Experience in reviewing and drafting agreements with GPOs and commercial contracts
• Experience in 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 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, rules, and regulations
• You can work both collaboratively and independently, while exercising initiative, flexibility, and sound business judgment
• You are comfortable working with different levels of the company, including senior level management and you can set priorities and juggle multiple demands
• You can keep things simple, focus on key messages and communicate clearly and you are able to find the balance between being detail-oriented and structured and acting fast, pragmatically and taking decisions. You take responsibility, meet deadlines and are good at establishing relationships

We offer 
A chance to work in an international company with unique technology and a dedicated workforce. We welcome people who share our passion with a willingness to make a difference. We offer a dynamic and flexible work environment and an opportunity to develop both your personal and academic competencies. We offer a comprehensive benefits plan and a competitive compensation package.

Salary Range - $230k - $290k

Location: US Remote – East Coast Preferred - US Headquarters: Durham, NC

Caught your interest?
If you are interested in the position, we look forward to receiving your application via our recruitment system. Just click the Apply Button and you will be redirected to our application form. 

Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values – our Bavarian Nordic DNA, as we like to call it – are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

www.bavarian-nordic.com

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