Description:

The position provides legal support to the Human Health Division, with a focus on counseling clients in the areas of FDA promotion and labeling of drugs and vaccines. The position also provides legal support to the Research Division and Compliance department on various matters. The role provides legal counseling services that are consistent with law and company policies, furthering business objectives while appropriately balancing legal requirements and risks.

Specific areas of responsibility include, but are not limited to:

Food, Drug, and Cosmetics Act compliance
Advertising and promotion
Product labeling
Clinical research activities
Commercial and Medical Affairs policies and practices
Policy initiatives in support of business and research activities
Related liability and regulatory issues

Position Qualifications:
Education Minimum Requirement:
Graduate of an accredited US law school; admission to the Bar of Pennsylvania or another state.

Required Experience and Skills:
At least 4 years of legal experience in a law firm or corporate setting, some of which must have been working in at least one of the following:

the FDA,
the pharmaceutical area OR
product liability litigation.

Preferred Experience and Skills:

Experience in product liability litigation and business counseling is a plus.?
The candidate must have excellent teamwork, communication and analytical skills and an aptitude for managing a portfolio of issues.
Knowledge of the laws applicable to the pharmaceutical industry is preferred
Experience in managing a significant workload, with the ability to juggle multiple projects simultaneously
Ability to be proactive, take initiative, and manage a portfolio of issues