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Legal Director (FDA promotion/Labeling Drugs & Vaccines)

Posted Jun 08
Full Time
HybridNorth Wales, Pennsylvania

Job Description

 

Position Description:

Legal Director (FDA promotion/Labeling Drugs & Vaccines)

 

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:

  • (1) the FDA,

  • (2) the pharmaceutical area OR

  • (3) 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

 

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

 

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

 

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.