Merck & Co.

Legal Director (FDA promotion/Labeling Drugs & Vaccines)

Merck & Co.

North Wales, PA 19454, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Welcome to Merck & Co., where we are dedicated to transforming the lives of patients through innovative medicines, vaccines, and healthcare solutions. As a Legal Director focused on FDA promotion and labeling of drugs and vaccines, you will play a critical role in ensuring our products meet all regulatory requirements and effectively communicate their benefits to patients and healthcare providers. We are seeking a highly skilled and experienced legal professional to join our team and help us continue to deliver life-changing treatments to those in need. If you are passionate about the intersection of law and healthcare and have a strong understanding of FDA regulations and guidelines, we encourage you to apply.

  1. Ensure compliance with all FDA regulations and guidelines related to drug and vaccine promotion and labeling.
  2. Review and provide legal guidance on advertising and promotional materials to ensure they accurately and effectively communicate product benefits.
  3. Collaborate with cross-functional teams including marketing, medical affairs, and regulatory to develop and implement promotional strategies that align with regulatory requirements.
  4. Monitor and stay up-to-date on changes to FDA regulations and guidelines related to drug and vaccine promotion and labeling.
  5. Conduct legal analysis and provide recommendations on complex issues related to product promotion and labeling.
  6. Develop and maintain strong relationships with internal stakeholders and external partners to facilitate effective communication and collaboration.
  7. Advise on potential risks and opportunities related to product promotion and labeling.
  8. Provide training and guidance to internal teams on FDA regulations and guidelines.
  9. Serve as a subject matter expert on FDA regulations and guidelines related to drug and vaccine promotion and labeling.
  10. Conduct legal research and stay abreast of industry developments to ensure best practices are followed.
  11. Manage relationships with external legal counsel as needed.
  12. Participate in industry conferences and events to stay informed on industry trends and best practices.
  13. Prepare and review legal documents related to FDA promotion and labeling, including submissions to regulatory agencies.
  14. Collaborate with global legal colleagues to ensure consistency in approach and compliance with international regulations.
  15. Represent the company in legal proceedings related to FDA promotion and labeling as needed.
Where is this job?
This job is located at North Wales, PA 19454, USA
Job Qualifications
  • Juris Doctor (J.d.) Degree From An Accredited Law School

  • Minimum Of 10 Years Of Legal Experience, With A Focus On Fda Regulations And Drug And Vaccine Labeling

  • In-Depth Knowledge Of Fda Laws And Regulations, Including The Federal Food, Drug, And Cosmetic Act (Fd&C Act) And The Code Of Federal Regulations (Cfr)

  • Strong Understanding Of Pharmaceutical Industry And Drug Development Processes

  • Demonstrated Experience Advising On Fda Promotional And Labeling Issues, Including Drafting And Reviewing Label And Promotional Materials For Drugs And Vaccines

Required Skills
  • Advertising

  • Strategic Planning

  • Project Management

  • Contract Negotiation

  • Product Launch

  • Team Leadership

  • Risk assessment

  • FDA regulations

  • Legal Analysis

  • Clinical development

  • Regulatory Affairs

  • Labeling Compliance

Soft Skills
  • Communication

  • Emotional Intelligence

  • Leadership

  • Time management

  • Interpersonal Skills

  • creativity

  • Organization

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Legal Director (FDA promotion/Labeling Drugs & Vaccines) in North Wales, PA 19454, USA is $156,000 - $235,000 per year. This may vary depending on the specific company, years of experience, and other factors.

Additional Information
Merck & Co. is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedMay 30th, 2024
Apply BeforeJuly 20th, 2025
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About Merck & Co.

Merck & Co., Inc., d.b.a. Merck Sharp & Dohme outside the United States and Canada, is an American multinational pharmaceutical company and one of the largest pharmaceutical companies in the world. Merck & Co., Inc. engages in the provision of health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. It operates through the following segments: Pharmaceutical, Animal Health, Alliances and Healthcare Services. The Pharmaceutical segment includes human health pharmaceutical and vaccine products marketed either directly by the company or through joint ventures.

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