Associate Director Regulatory Advertising & Promotions
My client is global pharmaceutical company providing treatment for various forms of cancer. Over the past 40 years, they have developed an extended, family-like atmosphere where the science and passion are aligned at the same level of importance. With the anticipation to grow by 40% this year, they are looking for an Associate Director of Regulatory Advertising and Promotions to be the face of commercial Regulatory Affairs and Ad Promo activities. With two marketed products and 4 programs in their development pipeline, this is a great opportunity with a company that is going from a small global company, to a mid-sized company.
Responsibilities:
- Be the primary liaison to regulatory agency on promotions and advertising
- Interface with corporate PRC/regulatory affairs on advertising and promotional materials
- Oversee the implementation of an electronic system for submission of advertising/promotional materials consistent with FDA guidance and timelines
- Review labeling, advertising and promotional materials to ensure scientific, medical accuracy and compliance with FDA, FTC, and applicable laws and regulations
- Review clinical, statistical and non-clinical data and determine how these relate to proper support for scientific, medical, and commercial claims in promotion of products
- Evaluate and implement an electronic system for distribution, review and approval of advertising and promotional materials at the PRC/MLR meetings
Knowledge and Skills:
- Minimum BS required, advanced degree preferred
- Minimum of 6-7 years industry experience with 3- 5 years of promotional material and labeling review experience with drugs and scientific/technical training and interaction with FDA’s OPDP
- Ability to improve existing processes, identifying opportunities for improvement, generating ideas and implementing solutions
- Ability to read, analyze and interpret regulations, guidance documents, clinical and medical literature, and other relevant complex documents
- Excellent written and verbal communication skills, Microsoft Office and Adobe application skills, able to prioritize and contribute to multiple projects, attention to detail
- Positive attitude, proactive, ability to work with minimal supervision and comfortable working and communicating independently