Associate Director, Regulatory Advertising& Promotion, Prescription Drug Products-Oncology (remote)

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.

Scope Of Position:

Manages strategic direction, training, and review of prescription drug product advertising and promotion materials, for compliance with company policy and regulatory agency requirements.

Who You Are

Minimum Qualifications:

• 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. Experience with oncology drug promotion and product launches preferred.

Preferred Qualifications:

• 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.

Location:  Remote position

Pay range for this position: $123,400 - $185,000. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

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What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!