At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
Help ensure compliance with quality system and standard operating procedure specific to the review and approval of promotional and scientific materials.
· Provide regulatory consultation/advice to Marketing, Medical Education & Strategy, Clinical, Research and Development, Regulatory Affairs, and other functions as needed with regard to promotional and scientific materials and activities to support AMO products.
· Responsible for the Ad/Promo Regulatory review of U.S. promotional and scientific materials within assigned product lines, and other products as needed.
· Partner with Regulatory Affairs on assigned product development teams as needed to provide regulatory advice/consultation, and gain alignment on promotional regulatory strategy, including the development of target claims and studies to support promotion of AMO products
· Demonstrate knowledge of and help ensures compliance with AMO/Abbott policies and procedures related to marketing and scientific activities supporting AMO products.
· Stay current on FDA and FTC advertising and promotion requirements, guidances and industry best practices
· Support the Associate Director RA as needed on various cross functional initiatives and product teams, representing Ad/Promo RA function as the subject matter expert to provide regulatory guidance to the organization on marketing and scientific activities.
· Assist Director RA in the development and management of AMO advertising and promotion training certification program
· Assist Associate Director RA with the creation and presentation of other training programs for the organization as needed.
· Identify continuous improvement opportunities to enhance process efficiency, effectiveness and increase
compliance within the quality system and SOP.
· Monitor AMO-Inc.com website content for accuracy and compliance in between the established annual review schedule.
Core Job Responsibilities
·Responsible for compliance with applicable Corporate and Divisional Policies and procedures
· Responsible for the Ad/Promo Regulatory review and approval of U.S. promotional and scientific materials for assigned products, and other products as determined by workload
· Responsible for helping ensure and maintain the effectiveness of and compliance with the quality system and procedure supporting the review and approval of materials
· Work across functions with Regulatory Affairs, Legal, Marketing, Clinical, Medical Education, and other functions as needed to provide regulatory consultation/advice on the development and execution of Marketing and Scientific materials/activities
· Develop and present training and/or LMS modules for the organization as needed on various Ad/Promo topics
· Monitor AMO-Inc website content for accuracy and compliance in accordance to an established schedule
· Partner with Advertising and Promotion Governance Board Program Manager to align Advertising and Promotion Quality System and business practices.
· Help develop and manage AMO advertising and promotion training certification program.
· Must interface with a wide variety of employees across functions.
· Must help to ensure promotional materials meet business needs and comply with all regulatory and company requirements.
· Must be able to effectively negotiate internally with other internal groups, and work across functions to support various business initiatives.
· Must help influence cultural change to improve compliance within the organization, through continuous education and by working upstream with Marketing, Clinical, Medical Education, and R&D colleagues in the development of materials and activities to support AMO products
· Must constantly seek to improve the efficiency and effectiveness of the quality system and standard operating procedure supporting the review and approval process.