Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
SCOPE
This role will be the lead legal advisor and partner to the commercial organization, including commercial operations, market access, and sales and marketing, as well as other areas of Azurity’s business and functional departments e.g. finance, supply chain and quality (as needed). As a trusted advisor, this will be a key role in supporting the business, including playing an active role in building a compliant culture, and help navigate the applicable legal and compliance complexities.
ROLE AND RESPONSIBILITIES
- Provide sound commercial legal advice for legal affairs of Azurity in Ireland, Switzerland, Netherlands, and applicable Azurity subsidiaries in Europe and International to ensure all business activities are carried out in compliance with applicable laws
- Proactively identify and analyze legal risks related to Azurity products based on applicable laws and regulations
- Draft, review and negotiate a range of agreements, including but not limited to wholesaler, distribution, product purchase, partnership, discount and rebate, data purchase, and patient hub services
- Provide solution orientated general commercial and other legal opinions to facilitate business
- Serve as legal advisor and business/sparring partner to commercial, with interaction with medical affairs, market access, finance and patient services teams (where necessary) for Azurity products
- Serve as lead lawyer on cross-functional product review committees including promotional review committee, and other business-oriented forums
- Provide high quality legal advice and counsel on advertising and promotional messaging, materials, and activities; speaker program materials and training; the dissemination of scientific communications; non-promotional disease awareness materials; patient assistance materials, programs and resources; payor marketing materials; and advisory board materials
- Advise business colleagues on interactions with key customer stakeholders, including patients, physicians, payors, and specialty pharmacies
- Review business materials (including brand plans, medical plans, training documents) requiring legal input and advising internal clients, partners and stakeholders on compliant and appropriate strategies, plans and tactics
- Work collaboratively with the compliance team to advise internal role players, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal compliance; keep abreast of current enforcement trends and educate clients and partners accordingly
- Work collaboratively with the legal team to draft and compile precedents, templates and opinions for use by wider legal team and/or business
- Become a trusted, go-to legal advisor with a perceived ‘can-do’ mentality, that advances the Azurity’s overall mission and goals while identifying and mitigating legal risks and its reputation
- Under the direction of the General Counsel for Europe, manage assigned legal initiatives and projects
QUALIFICATIONS AND EDUCATION REQUIREMENTS
- Ability to read, write and communicate in English mandatory, with multiple language-ability such as in German, will be an added advantage
- Applicable baccalaureate degree and licensed to practice law in a member state of the European Union
- Membership and in good standing in the applicable bar
- 5-7+ years of post-admission experience, preferably including both at law firm and in-house level in the pharmaceutical industry
- Strong experience in drafting, reviewing and negotiating a wide range of commercial agreements independently – as an essential requirement
- MLR (medical legal review) involvement/experience very important
- Experience advising on statutes, regulations and laws relevant to the commercialization of pharmaceutical products, including (or the European equivalent hereof) the False Claims Act; FDCA, FDA promotion and labeling; federal and state anti-kickback statutes; OIG guidance documents and advisory opinions; U.S. transparency laws; anti-bribery laws, and other laws and regulations related to the commercialization of pharmaceutical products
- Excellent oral and written skills
- Willingness to take on any task - no task too big or too small - as the circumstances may dictate
- Self-motivated, strong leadership, work well independently on projects, meet aggressive deadlines, handle multiple projects, technical knowledge, business acumen, and excellent communication skills
- Sound conflict resolution skills and ability to work in a collaborative, global environment
#LI-Hybrid
