Providing legal expertise with US Brand Teams (and partner companies when applicable) to ensure:
Compliance with all applicable regulations, internal policies, and internal quality systems.
High quality, timely and decisive legal advice (with appropriate consultation and supervision of
licensed legal professionals) to allow business partners to make well-informed decisions.
Development of promotional messages that educate customers about the benefits and risks of
products by introducing multiple alternative approaches that may meet the business objectives while
maintaining compliance with applicable regulations and internal policies.
Support implementation of the Customer Information Quality (CIQ) system, including
development and review of product and disease state communications within the CIQ
processes
Ensure legal requirements are met for projects.
Participate actively in making recommendations regarding proposed promotional activity plans in
the US.
Exercising accountability for knowledge transfer within the Legal Team, Legal and the broader
enterprise by:
Sharing learnings with the Business Unit Legal Team (BULT)
Sharing learnings with cross-functional medical, regulatory and marketing colleagues
Supporting development and implementation of internal promotional guidelines and standards as relevant
to the applicable portfolio
Attending internal and external training programs, FDLI and other trade meetings
Supervising and coaching two Legal Managers supporting US Brand Teams, taking a leadership role in
their training, coaching and development (with appropriate consultation and supervision of supervising
Assistant General Counsel)Basic Qualifications:
Bachelor of Legislative Law (LLB)
A minimum of 7 years of relevant experience providing legal services in a regulated environment, in
house at a pharmaceutical or biotechnology company's law department or as a paralegal in a law firm
working with clients in a regulated industry or a combination of the two
Industry-related experience and knowledge of FDA regulations and practices
Additional Skills/Preferences:
Demonstrated ability to drive solutions that impact an enterprise and/or globally.
Demonstrated ability to influence people and decisions.
Demonstrated ability to assess and manage risk in a highly regulated environment.
Strong analytical skills and ability to craft innovation solutions to complex issues, focusing on simplicity
and practicality.
Highly motivated and collaborative partner with strong interpersonal skills and the ability to work
effectively with team members, other lawyers, regulatory, medical and leadership.
Good judgment and a meticulous level of attention to detail
Excellent written and verbal communication skills with an ability to effectively communicate legal issues
and influence others at all levels of the company.
Demonstrated commitment to expand knowledge and adapt to a changing environment
