Associate Director, Regulatory Affairs Advertising & Promotion

Employer
Celgene
Location
Summit, NJ, US
Posted
Nov 21, 2018
Ref
1802662
Required Education
Bachelors Degree
Position Type
Full time
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary/Scope:

Responsibilities will include, but are not limited to, the following:
  • Provide strategic regulatory guidance on advertising and promotion materials and activities, including the development of launch materials/new claims, in accordance with business goals and objectives.
  • Review and approve of advertising and promotional materials for marketed products, press, educational, and training materials as assigned.
  • Review and approve of direct-to-consumer (DTC) pharmaceutical broadcast advertising and print materials.
  • Ensure regulatory compliance with all applicable laws, regulations and regulatory guidelines governing promotional programs and scientific interactions with healthcare professionals, payers, advocacy, and other business partners.
  • Provide risk assessment for marketing and medical campaigns.
  • Propose regulatory advisory submission strategies, prepare communications, and oversee the timely and accurate submission of promotional materials to OPDP.
  • Maintain up-to-date knowledge of US regulatory promotional environment by reviewing regulatory promotional guidelines and enforcement letters to pharmaceutical companies, advising internal stakeholders as warranted.
  • Provide training in FDA regulations for advertising and promotion to internal employees.
  • Ensures that changes in US Package Insert are appropriately implemented and reflected in current promotions and advertising.
  • Coach and mentor junior staff within the department.
  • Foster and facilitate teamwork within the Promotional Approval Cross-functional Team (PACT) process.

Key Requirements/Knowledge:
  • Bachelor's degree in science (BS) required. Advanced degree (MS, MPH, PharmD, PhD, or JD) preferred.
  • 5-9 years pharmaceutical industry experience with 3-5 years in regulatory affairs, with at least 3 years in regulatory advertising and promotion.
  • Knowledge of FDA advertising and promotion regulations and guidance is necessary.
  • Experience with regulatory review and approval of direct-to-consumer pharmaceutical advertising (Broadcast DTC experience is a plus)
  • Understanding of, and experience with, regulatory framework applicable to interactions with healthcare providers, payers, advocacy, and other business partners.
  • Proven ability to analyze and interpret efficacy and safety data.
  • Excellent communication, listening, and negotiation skills, the ability to strategically influence business partners and FDA, and a mature appreciation of how the commercial objectives of the company can be delivered, while at the same time meeting FDA compliance standards, are necessary
  • Leadership skills and demonstrated ability to influence teams is required.
  • Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously.
  • Must be innovator of new ideas and best practices.
  • Must recognize potential problems and resolve problems.
  • Possess outstanding attention to detail.
  • Domestic travel may be necessary.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.