Director, Advertising and Promotion, Prescription Drug Products (remote)

Posté 22 janv. 2024

Billerica, Massachusetts - United States

Demander un identifiant 271258

 

Work Your Magic with us!

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.

 


Your Role:
The Director of Advertising and Promotion, Prescription Drug Products manages and/or participates in the review, approval and monitoring of prescription drug advertising and promotional labeling pieces.  The Director is responsible for ensuring the pieces are in compliance with all applicable laws, regulations, and regulatory agency guidance. 

  • Manages or 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 in compliance 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.
  • Manages strategic direction, training, and review of prescription drug product advertising and promotion materials, for compliance with company policy and regulatory agency requirements.
  • Represents Regulatory Affairs as required as an active key participant on cross functional prescription product promotional review teams, consisting of members from marketing, legal, medical and Regulatory Affairs.
  • Participates in development committees for processes and procedures related to advertising and promotion. 
  • Interacts with Quality related to internal audits and CAPAs, as needed.

 

Who You Are:
Minimum Qualifications:

  • Bachelor’s degree in science or health related discipline (Advanced degree [PhD, MD, MS, PharmD highly preferred)
  • Seven or more years of relevant pharmaceutical industry experience with 5 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

 

Preferred Qualification:

  • Experienced with oncology drug promotion and product launches preferred.
  • Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs.
  • Demonstrated ability to contribute to a continuous learning and process improvement environment.

 

Location: 

  • Remote


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it 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 our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

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