Associate Director, Regulatory Affairs Advertising and Promotion

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Req #:
Location: Summit, New Jersey, United States
Job Category: Regulatory Affairs
Work Location: 86 Morris Avenue 07901
Organization: Regulatory Affairs
Employee Status: Full-time
Job Type: Regular

Summary/Scope:
Responsibilities will include, but are not limited to, the following:
  • Determine and provide strategic regulatory advice on advertising and promotion materials and activities, including the development of launch materials/new claims, in accordance with business goals and objectives
  • Review and approval of advertising/promotional materials for marketed products, press, educational, and training materials as assigned
  • 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 assessment of risk 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.
  • Coaches and mentors junior staff within the department
  • Fosters and facilitates teamwork within the Promotional Approval Cross-functional Team (PACT) process.
Key Requirements/Knowledge:
  • Bachelors 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.
  • 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 PACT and Regulatory teams 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.
  • Must have outstanding attention to detail.
  • Domestic travel may be necessary.
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About Us

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

\"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.\"

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Associated topics: advertise, advertising, b2b, business, market, media, product marketing, sales, strategy, sales and marketing