About You
ROLE OVERVIEW
Provides legal advice, counsel and service to internal management concerning legal rights, obligations, and privileges of corporations.
Keeps current on legislative issues, statutes, decisions and ordinances.
Examines legal data to determine advisability of defending or prosecuting lawsuits.
Acts as agent of corporation in various transactions. May work with outside counsel to direct activities.
RESPONSIBILITIES AND ACCOUNTABILITIES
Responsible for providing Legal Support Services and Strategic Counsel for CSLV US operations.
Advises CSLV on US Legal services, with legal peers in different jurisdictions by providing hands-on, solution-oriented advice regarding all legal
matters.
Serves as an active and commercially-minded partner to CSL Vifor in the US market, including market access, and medical affairs teams.
Directs contract strategy and provides legal support for advertising, promotional, and communications campaigns.
Provides strategic counsel on drug regulatory, GxP and other relevant laws and regulations.
Ensures business processes and activities comply with applicable laws, regulations, and company policies.
Collaborates closely with compliance colleagues to ensure legal compliance with applicable laws, regulations, and codes, including fraud and abuse
laws, FDA laws regulating the sale and marketing of pharmaceutical products, the Sunshine Act, the Anti-Kickback Statute, and the Foreign Corrupt
Practices Act.
Supports the General Counsel CSLV on Business Development and Licensing transactions
Supports the General Counsel CSLV in managing the Company's litigation, legal claims, and disputes in the US relating to the Company’s global business.
Manages and mentors attorneys and other team members of CSLV US
EDUCATION
Bachelor’s degree and J.D. or equivalent foreign degree.
Bar admission in the US.
REQUIREMENTS
At least 15 years of legal experience
In-house experience in roles of increasing scope and responsibility within the US biotechnology, pharmaceutical, or related life science industries
is required. Foundational law firm training is strongly preferred.
Broad legal experience supporting a commercial biopharmaceutical company and demonstrated experience providing sophisticated commercial legal
leadership and support is required.
Experience with corporate transactions of all kinds.