Lundbeck
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Senior Counsel
role at
Lundbeck Lundbeck is a global biopharmaceutical company focusing exclusively on brain health, with more than 70 years of experience in neuroscience. We are committed to improving the lives of people with neurological and psychiatric diseases and transforming lives through brain health. Join us on our journey of growth!
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; keeps abreast of changes in laws that affect client areas.
Advises internal teams on co-promotion arrangements 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 a collaborative working environment.
Stays informed of advisory roles in selective situations and assumes responsibility as needed.
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 and 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.
Additional information The salary range and benefits vary by location and are determined based on qualifications and other factors. Benefits commonly include PTO, health benefits (Medical, Dental, Vision) and a 401(k) plan. Lundbeck is an equal opportunity employer and participates in E-Verify. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law.
For more information, visit our U.S. career site.
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Senior Counsel
role at
Lundbeck Lundbeck is a global biopharmaceutical company focusing exclusively on brain health, with more than 70 years of experience in neuroscience. We are committed to improving the lives of people with neurological and psychiatric diseases and transforming lives through brain health. Join us on our journey of growth!
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; keeps abreast of changes in laws that affect client areas.
Advises internal teams on co-promotion arrangements 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 a collaborative working environment.
Stays informed of advisory roles in selective situations and assumes responsibility as needed.
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 and 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.
Additional information The salary range and benefits vary by location and are determined based on qualifications and other factors. Benefits commonly include PTO, health benefits (Medical, Dental, Vision) and a 401(k) plan. Lundbeck is an equal opportunity employer and participates in E-Verify. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law.
For more information, visit our U.S. career site.
#J-18808-Ljbffr