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Director, Regulatory Affairs Advertising and Promotion

4 months ago

Fort Worth, United States Alcon Full time

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.


We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Director, Regulatory Affairs, Advertising, and Promotion mainly supporting US Regulatory Affairs and also Global (OUS) as required, you will be trusted to provide proactive, strategic regulatory advice and guidance on promotional strategies and options as a key member of Franchise business teams, and the QRA organization at Fort Worth, TX.


In this role, a typical day will include:

  • Evaluate and assess claims strategies for new products in development, using scientific knowledge of substantiation criteria and regulatory strategies across preclinical, clinical, market research, and other data-generating areas.
  • Ensures that promotional advice accords with business goals and objectives, FDA regulations/guidances, and OUS guidelines, such as EUMDR, Health Canada, and company policy.
  • Coordinates creative and innovative approaches to competitive claims and asset strategies for the Franchise area, using a strong background in medical product development, claims substantiation in the medical products industry, and awareness of current industry trends.
  • Develop, in partnership with Legal, Medical, and Commercial, effective and timely challenges to competitor claims activities. Serves as a senior Ad/Promo team member on Competitive Response Teams
  • May direct the activities of regulatory personnel responsible for MAP operational activities for a Franchise area, or senior contract reviewers, as needed/assigned.
  • Serves as a senior regulatory reviewer for assigned products/Franchise promotional assets across a diverse range of communication channels, including social media. Ensures regulatory compliance while effectively assessing and leading business risks.
  • Initiate, develop, and deliver promotional training across the business partnering with Legal and Medical to facilitate the effective delivery of promotional assets
  • Actively engage in onboarding new hires, junior colleagues, fellows, and interns within the regulatory team and provide training/mentoring/coaching to these individuals.
  • As a senior representative for GRA Ad/Promo on internal, cross-functional, cross-franchise initiatives, provides leadership, comprehensive input, and decision-making to facilitate collaborative team goals.
  • Maintains awareness of competitive activities by ensuring regulatory monitoring of major international and US and International Medical meetings.
  • Monitors US and OUS regulatory promotional environment by reviewing regulatory motional guidelines, published enforcement letters (FDA, FTC, NAD, UKABPI) or advisories from key international bodies, and by attendance at major FDLI, DIA, and other industry meetings as appropriate.
  • Provide the US and Global Regulatory promotional perspective to various business functions to ensure commercially viable labeling that will support business strategies.
  • Provides strategic input into the development of product labeling to maximize opportunities to support promotional activities, with a strong understanding of the links between product labeling and viable claims strategies.


WHAT YOU'LL BRING TO ALCON:

  • Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs.; Assoc.+14 yrs.; M.S.+7 yrs.; PhD+6 yrs.)
  • The ability to fluently read, write, understand, and communicate in English
  • 10 Years of Relevant Experience
  • 6 Years of Demonstrated Leadership
  • Travel Requirements: 15%
  • Relocation assistance: Yes
  • Sponsorship available: No


PREFERRED QUALIFICATIONS, SKILLS, EXPERIENCE

  • Strong background in working effectively with Commercial teams and understanding of the competitive business environment around product launches and campaigns.
  • Excellent understanding of US and key OUS regulations for drug and medical device promotion/advertising and US labeling.
  • Experience in the regulatory review of professional and consumer medical products and drug advertising and promotion.
  • Proven ability to provide strategic direction and innovative, forward-thinking regulatory guidance, as well as analyze and interpret efficacy and safety data and translate this information into a range of flexible claims strategies.
  • Experience with using new and social media platforms for promotion
  • Experience with regulatory activities involved with a product launch.
  • Strong understanding of business goals of the involved business franchise, marketing concepts, and tools.
  • Exceptional ability to independently problem solve, negotiate, influence, collaborate, and make decisions.
  • Must possess strong interpersonal and communication skills across diverse customer groups and business partners.


HOW YOU CAN THRIVE AT ALCON:

  • Collaborate with teammates to share standard processes and findings as work evolves.
  • A career at Alcon offers focused growth and development opportunities
  • Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career
  • Alcon provides a robust benefits package including health, life, retirement, flexible time off for exempt associates, and much more