Associate Director, Reg Affairs Ad & Promo Job

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Date: Jun 8, 2014 Location: Berkeley Heights, New Jersey, United States 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: • Manage regulatory aspects of Post-Marketing regulatory submissions and communications with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) [formerly the Division of Drug Marketing, Advertising and Communications (DDMAC)]. • Develop regulatory, strategic, and compliance plans for maximizing the commercial aspects for the marketing of Celgene’s products. Manage timelines and resources to achieve stated goals. • Advise the Corporation on relevant new and existing regulatory risk and compliance requirements and provide regulatory expertise, advice, and support to Sales & Marketing and other product-related teams and the Copy Review Committee (CRC). Foster and facilitate teamwork between GRA and these allied functions. • Contribute to the development and implementation of Corporate and Department procedures and policies for regulation of marketed promotional materials and press releases. • Provide leadership for and manage regulatory aspects of the copy review / approval process for product promotional materials, maintain compliance of promotional materials with the governing FDA regulations, and submit promotional materials to OPDP in a timely fashion. • Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of Celgene’s pharmaceutical products. Pro-actively monitor the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape. Provide colleagues in GRA and allied functions with cutting edge guidance on requirements and changes. • Foster collaborative, efficient, and effective working relations with FDA in order to further build the cordial working relationship between Celgene and FDA. • Work closely with the GRA rep on Project Teams to support A&P Activities. 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. *LI-JW1 Qualifications Key Requirements/Knowledge: • BS or MS in scientific discipline or equivalent. Advertising and Promotional experience is a must. • 5-9 years of pharmaceutical industry experience, including 3-5 years in regulatory affairs. Preference for at least 3 years experience in post-marketing regulatory affairs, specifically pharmaceutical promotional activity. • Knowledge of Advertising and Promotional FDA regulations and experience with FDA communication and contact is necessary. • Excellent interpersonal skills and written and oral communications skills. • Excellent organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously. • Must be able to innovate, analyze, and solve problems with minimal supervisory input. • Able to accommodate modest amount of domestic travel. • Ability to manage multiple responsibilities with high degree of self-motivation. Req ID: 14000255 Primary Location: United States-New Jersey-Berkeley Heights Job: Regulatory Affairs Organization: Celgene Corporation Schedule: Regular Shift: Standard Employee Status: Individual Contributor Job Type: Full-time Job Level: Day Job Travel: Yes, 15 % of the Time Job Posting: 2014-02-12 00:00:00.0
Phama Job Categories: 
USA
Regulatory Affairs

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