Associate Director, Regulatory Advertising and Promotion, Prescription Drug at EMD Serono

Billerica, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

15 Feb, 26

Salary

185000.0

Posted On

17 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Advertising, Promotion, Compliance, Strategic Support, Communication, Interpersonal Skills, Teamwork, Detail-Oriented, Pharmaceutical Industry, Labeling Development, Safety Information, Process Improvement, Training, Monitoring, Guidance

Industry

Pharmaceutical Manufacturing

Description

Work Location: Billerica, Massachusetts Shift: No Department: HC-RD-RPD US Ad/Promo Recruiter: Rena Ann Peterson This information is for internals only. Please do not share outside of the organization. Your Role: The Associate Director of Advertising and Promotion, Prescription Drug Products participates in the review, approval and monitoring of prescription drug advertising and promotional labeling pieces. The Associate Director is responsible for ensuring the pieces are compliant with applicable laws, regulations, and regulatory agency guidance. 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. Scope Of Position: Manages strategic direction, training, and review of prescription drug product advertising and promotion materials, for compliance with company policy and regulatory agency requirements. Who You Are Minimum Qualifications: Bachelor’s degree in science or health related discipline ((Advanced degree [MS, PharmD] preferred) Four or more years pharmaceutical industry experience with 3 years of relevant Regulatory Affairs prescription product advertising and promotion review experience. Preferred Qualifications: Knowledge of regulations related to prescription drug promotion Working knowledge of Rx NDA, BLA and labeling development and approval process Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency Strong interpersonal skills with the ability to lead and influence, cross-functional colleagues in a positive and effective manner Ability to work in a team environment Excellent communication skills, both oral and written Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs. Location: Remote position Pay range for this position: $123,400 - $185,000. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Responsibilities

The Associate Director participates in the review, approval, and monitoring of prescription drug advertising and promotional labeling pieces to ensure compliance with applicable laws and regulations. They represent Regulatory Affairs on promotional review committees and implement regulatory strategies to assure compliance with company policies.