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Associate Director, Regulatory Advertising & Promotion, Prescription Drug Products-Oncology (remote)
About the position Work Your Magic with us! Start your next chapter and join EMD Serono. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: The Associate Director of Advertising and Promotion, Prescription Drug Products participates in the review, approval and monitoring of prescription drug advertising and promotional labeling pieces. The Associate Director is responsible for ensuring the pieces are compliant with applicable laws, regulations, and regulatory agency guidance. Responsibilities • Represents Regulatory Affairs on the promotional review committees for prescription products to review promotional materials for compliance with regulatory requirements while meeting the Company's strategic promotional objectives. • Implements regulatory strategies and solutions to assure that US advertising and promotional materials are compliant with regulatory requirements and Company policies. • Provides guidance and strategic support on proposed claims for products in development and helps develop Important Safety Information (ISI) and Brief Summary documents as appropriate. • Continually develops, assesses and revises advertising and promotion-related processes and SOPs as needed, to enhance efficiencies and compliance. • Regularly monitors the regulatory compliance trends in industry, interprets new regulations, guidance documents and enforcement letters. • Updates the Regulatory Affairs advertising and promotion staff, review committees and appropriate other Company staff regarding changes in the current regulatory environment at FDA’s Office of Prescription Drug Promotion (OPDP), Advertising and Promotional Labeling Branch (APLB), and other regulatory considerations that may impact business. • Works closely with the Regulatory Affairs prescription drug labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion. • Develops communication packages for regulatory advice, response to FDA action letters, and leads the company in discussions with OPDP and APLB. • Coordinates company-wide ongoing training on regulatory issues pertaining to product promotion. • Other job responsibilities as needed. Requirements • Bachelor’s degree in science or health related discipline ((Advanced degree [MS, PharmD] preferred) • Four or more years pharmaceutical industry experience with 3 years of relevant Regulatory Affairs prescription product advertising and promotion review experience. • Knowledge of regulations related to prescription drug promotion • Working knowledge of Rx NDA, BLA and labeling development and approval process • Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency • Strong interpersonal skills with the ability to lead and influence, cross-functional colleagues in a positive and effective manner • Ability to work in a team environment • Excellent communication skills, both oral and written • Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. Nice-to-haves • Experience with oncology drug promotion and product launches preferred. Benefits • Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. Apply tot his job
