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Senior Manager, Regulatory Affairs Advertising
4 months ago
Overview:
The Senior Manager, Regulatory Affairs Advertising & Promotion is responsible for directing the regulatory aspects of internal and external communications including advertising and promotional activities. They will coordinate the development and implementation of regulatory strategies for promotion and advertising plans and are a leader in the review process to support approval and dissemination of marketed product promotional material. Liaises with FDAs Office of Prescription Drug Promotion (OPDP) for Advertising and Promotion submissions.
Responsibilities:- Leads the development and oversight of the processes and procedures relevant to the creation, review, and approval of advertising and promotional materials as part of Xeris Regulatory review process and other external communication to ensure regulatory compliance.
- Leads the development and oversight of the processes and procedures relevant to the creation, review, and internal approval of FDA-approved prescribing information, Medication Guides, and patient labeling.
- Reviews external communications materials, sales, and marketing materials, including training, for compliance to current regulations and guidance.
- Participates in training of sales and marketing personnel on advertising and promotional material.
- Represents the company to outside customers and agencies and makes presentations as needed on current regulatory issues pertaining to advertising and promotional activities.
- Provides leadership for and manages regulatory aspects of the copy review / approval process for promotional materials; ensures compliance of promotional materials with FDA laws, regulations, and published guidance documents.
- Contributes to the development and implementation of corporate policies and procedures for regulation of promotional materials and other external communications/press releases.
- Develop and maintain SOPs and processes for review, approval, and submission of advertising and promotional materials to the FDA. Work closely with the Legal, Medical Affairs, and Commercial business units on improving and enhancing the review process, establishing consistent best practices and submission guidelines.
- Coordinate and implement training of employees on regulatory issues pertaining to promotion of company products.
- Bachelors degree in a scientific discipline; advanced degree preferred.
- A minimum of 6 years of progressively responsible Regulatory Affairs experience with a focus on advertising and promotional regulations.
- Experience communicating and negotiating directly with OPDP and performing risk assessments.
- Significant demonstrated experience developing and executing complex and innovative global regulatory strategies, assessing & communicating risk/benefit to senior management, and influencing organizational direction as it pertains to compliance of advertising and promotion materials.
- Experience with labeling development and life-cycle management.
- Experience with advertising and promotions on social media platforms and Direct-to-Consumer (DTC) knowledge strongly preferred.
- Strong knowledge of US regulatory environment and FDA regulations and guidance regarding advertising and promotional materials for Drugs, Biologics, and Medical Devices.
- Competencies: Strategic Leadership, Teamwork & Collaboration, Attention to Detail, Self-Starter, Negotiation skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills
Working Conditions
- Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
- This position is based in Xeris Chicago office and requires a minimum of three days per week in the office.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
