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EMD Serono, Inc. · 10 hours ago

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

United States

Full-time

Remote

Lead/Staff, Director/Executive

$123K/yr - $185K/yr

4+ years exp

EMD Serono, Inc. is committed to enriching lives through innovative healthcare solutions. The Associate Director of Advertising and Promotion is responsible for ensuring compliance of prescription drug advertising and promotional materials with regulatory requirements while supporting the strategic promotional objectives of the company.

BiotechnologyHealth CareHealth Diagnostics

Work & Life Balance

No H1B

Responsibilities

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 compliant 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

Qualification

Regulatory Affairs experiencePrescription drug promotion knowledgeNDABLA process knowledgeDetail-orientedPharmaceutical industry knowledgeInterpersonal skillsTeamworkCommunication skills

Required

Bachelor's degree in science or health related discipline

Four or more years pharmaceutical industry experience with 3 years of relevant Regulatory Affairs prescription product advertising and promotion review experience