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Executive Director, Group Head, Advertising and Promotion Review

2 months ago

Canada, CA Organon LLC Full time
Executive Director, Group Head, Advertising and Promotion Review

Job Description

The Position

The successful candidate will lead a team of Advertising and Promotion reviewers responsible for review and approval of assigned projects. This may include products in all phases of development through registration and mature products. The Group Head could also support business development due diligence activities.

Responsibilities

  • Lead the team supporting review of US promotional materials for compliance with the letter and spirit of FDA regulations, Industry standards and Organon policies and standards.
  • Identify and assess company risk of non-compliance in a complex environment.
  • Provide support of ongoing product development activities through demonstration of incorporation of label and clinical programs to translate into compelling and compliant commercial messaging.
  • Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues affecting the pharmaceutical/biologics industry.
  • Provide strategic and technical advice throughout product life cycle, making an important contribution both commercially and scientifically to the success of a development program.
  • Support BD due diligence efforts and define promotional regulatory risks of asset acquisitions and partnerships.
  • Lead cross-functionally to deliver innovation and promotional regulatory strategy in collaboration with Commercial, PRT, Global Regulatory Liaisons, Medical Affairs and Worldwide Product Labeling.
  • Guide and coach team on Organon transformation, efficiency, while being accountable for the team’s performance.
  • Provide technical and professional leadership and conduct all appropriate HR activities such as managing performance, development planning, staffing and related people-management responsibilities for personnel within areas of responsibility.
  • 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. Serve as the expert to internal leadership on risk assessment for new commercial initiatives.
  • Engage in appropriate activities to improve the regulatory environment through Agency Contacts: OPDP, APLB and associations as appropriate.

Required Education, Experience and Skills

  • B.S., M.S., M.D. or PhD in biological science, chemistry or related discipline preferred.
  • 12-15 years of drug/medical device development experience, the majority of which was in US Advertising and Promotion Review.
  • Additional experience with ex-US promotional activities is highly desirable but not required.
  • Demonstrated scientific knowledge, writing ability, effective communication and familiarity with worldwide regulatory agencies.
  • Experienced in negotiations with health authorities.
  • Outstanding interpersonal, communication and negotiation skills.
  • Demonstrated leadership attributes; experienced at building and leading high performing teams; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities.
  • 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.

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

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