Associate Director, Regulatory Affairs - Advertising & Promotion

Essential Job Functions

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.

Strategically supports 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.

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.

Develops and maintains SOPs and processes for review, approval, and submission of advertising and promotional material.

Works closely with the Legal, Medical Affairs, and Commercial business units on improving and enhancing the review process and associated system, and on establishing consistent best practices.

Leads coordination and training of employees on regulatory issues pertaining to promotion of company products.

Skills And Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• Minimum of 7 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.
• Strong knowledge of US regulatory environment and FDA regulations and guidance regarding advertising and promotional materials for Drugs, Biologics, and Medical Devices.
• Experience with artificial intelligence (AI) technologies or AI-enabled process improvements highly desirable.

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 two days per week in the office.

Pay, Benefits & Other Information

• The anticipated base salary range for this position is $174,000 to $232,000.
• Xeris Pharmaceuticals, Inc. (the “Company”) is an equal opportunity employer and does not discriminate based on race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law.
• Candidates are always welcome to inquire about our compensation and benefits package during the interview process.
• Individuals hired as temporary employees, interns, and preceptors are not eligible for commissions, bonuses, and/or long-term incentive or equity awards.
• Eligibility for other benefits will be based on plan documents.

Accessibility & Reasonable Accommodations

• If, because of a medical condition or disability, you require a reasonable accommodation or assistance to complete any part of the application process, please send an e-mail to recruiting@xerispharma.com and identify the type of accommodation or assistance you are requesting. Please include the job requisition number in your message.

EEO is the Law

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