Executive Director, Group Head, Advertising and Promotion Oversight

7 days ago


Jersey City, New Jersey, United States Organon Full time
Job Summary

Organon is seeking a highly experienced and skilled Executive Director, Group Head, Advertising and Promotion Oversight to lead our Advertising and Promotion Review team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities
  • Lead a team of regulatory affairs professionals in reviewing and approving advertising and promotional materials for compliance with FDA regulations and industry standards.
  • Identify and assess company risk of non-compliance in a complex environment.
  • Provide strategic and technical advice throughout the product life cycle, making a significant contribution to the success of our development programs.
  • Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters, and policy issues affecting the pharmaceutical/biologics industry.
  • Support business development due diligence activities and define promotional regulatory risks of asset acquisitions and partnerships.
  • Collaborate with cross-functional teams to deliver innovative and promotional regulatory strategies.
  • Guide and coach team members on Organon's transformation and efficiency initiatives, while being accountable for the team's performance.
  • Provide technical and professional leadership, conduct HR activities, and manage performance, development planning, staffing, and related people-management responsibilities.
  • Develop company standards and future strategies on promotion relating to media placement, social media, and other innovative platforms for drugs and devices.
  • Develop and implement departmental strategic initiatives and serve as an expert to internal leadership on risk assessment for new commercial initiatives.
  • Engage in activities to improve the regulatory environment through agency contacts and associations.
Requirements
  • Bachelor's, Master's, M.D., or Ph.D. in biological science, chemistry, or a related discipline.
  • 12-15 years of experience in drug/medical device development, with the majority in US Advertising and Promotion Review.
  • Additional experience with ex-US promotional activities is highly desirable.
  • Demonstrated scientific knowledge, writing ability, effective communication, and familiarity with worldwide regulatory agencies.
  • Experience in negotiations with health authorities.
  • Outstanding interpersonal, communication, and negotiation skills.
  • Demonstrated leadership attributes, experienced at building and leading high-performing teams, and exemplifies corporate and ethical integrity.
  • Ability to solve problems through investigation and solution identification.
  • High degree of professionalism and sound judgment, working well with others.
  • Driver of change and innovation.
  • Demonstrate sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.


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