Description:
Summary:The Senior Counsel position is responsible for handling a variety of substantive legal issues, providing legal, regulatory and compliance counsel to Lundbeck's US rapidly growing business units and senior management.
Essential Functions:
- Supports marketed pharmaceutical products and products in development by providing substantive advice to US operations, including Marketing, Medical Affairs and Regulatory Affairs departments, concerning a broad range of business, legal, regulatory and compliance issues, including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act, privacy and data security laws and regulations, and competition law, in connection with product labeling, promotional and non-promotional activities, marketing strategies, sales activities and compensation, pharmacovigilance and medical information and interactions with healthcare professionals.
- Reviews marketing and other external materials for compliance with applicable laws, regulations, and company policies
- Collaboratively evaluates and resolves legal and strategic issues working on cross-functional projects and communicates solutions verbally and in writing to management and senior management.
- Effectively communicates legal issues and risks to internal and external stakeholders regarding Lundbeck's business and supported areas.
- Internally supports key stakeholders; keeping abreast of changes in laws that affect client areas.
- Advises internal teams on co-promotion arrangement and liaises with co-promotion partner contacts as needed.
- Prepares, reviews and negotiates commercial agreements, vendor agreements, service agreements, consulting agreements, corporate agreements, confidentiality agreements and certain medical affairs agreements.
- Serves as legal representative on various business and operational committees.
- Provides guidance and direction to paralegal team responsible for day to day contracting.
- Resolves legal issues using negotiation skills and legal expertise.
- Serves as a resource to colleagues regarding specific areas of knowledge and fosters collaborative working environment.
- Steps into advisory role in selective situations and assumes responsibility as need arises.
Required Education, Experience and Skills:
- JD Degree from an ABA accredited law school
- Admission to the Bar in Illinois or willing to be admitted to the Illinois Bar
- 4+ years of experience as an attorney/counsel, with at least 2 years in a Law firm
- Exceptional written, verbal, and presentation communication skills, including strong business communications and contract drafting skills
- Ability to translate legal principles to management and other line function personnel
- Ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of colleagues and employees
Preferred Education, Experience and Skills:
- Previous experience counselling clients within the pharmaceutical, medical device or biotech industries
- Familiarity with FDA drug and biologic law, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act, privacy and data security laws and regulations, competition law and US pharmaceutical compliance program requirements
- Demonstrated experience drafting and negotiating operational contracts
- Litigation experience
- Market Access experience
- Experience supporting Commercial Business
- Experience working in or advising on co-promotion arrangements
- Advertising and Promotional Review experience
Travel:
Willingness/Ability to travel up to 10% domestically. International travel may also be required.
