Senior Manager, Promotional Review Process Lead, USRA- Advertising & Promotion J

Overview

The Senior Manager, Promotional Review Process Lead will oversee all aspects of the commercial US Review Committee (USRC) process. This individual will serve as the primary contact for the promotional review process and work as a liaison between Commercial Leads, Reviewers, and Agencies for assigned products. Responsibilities also include identifying best practices, guiding short- and long-term planning, improving process efficiencies, stakeholder training, and managing other promotional review process associates. Reporting to the Senior Director, USRA Advertising and Promotion, the Manager / Senior Manager will be a critical member of the USRC and strategic partner for the review and approval process.

Responsibilities

• Lead and manage the end-to-end review and approval lifecycle of promotional materials, utilizing electronic review system, Veeva PromoMats
• Collaborate cross-functionally with Commercial, Regulatory, Legal, Medical, and Agency partners
• Lead the coordination of the USRC activities and ensure that the promotional review process is conducted both in a highly compliant and efficient manner
• Facilitate high quality USRC meetings, including agenda planning, time management and accurately capturing consensus comments at live reviews
• Review and ensure that all submissions are complete and meet certain quality standards prior to circulation to reviewers and provide proactive guidance as needed
• Collaborate with Commercial and Agency partners on submission timelines to meet business deadlines and initiatives
• Track promotional materials from inception through approval and provide actionable feedback where there are workflow issues
• Monitor document lifecycle, including reapprovals and expiry of materials in accordance with USRC SOP
• Involved in planning and execution of product launches, new indications, and label updates in partnership with Commercial and Regulatory
• Provide continuous training to internal and external stakeholders on USRC process and systems, including new hire and refresher training, and update training presentations as needed
• Proactively lead project work supporting continuous improvement and process innovation, and partnering with the USRC team to share ideas and support team growth
• Track USRC reviewer comments and elicit necessary revisions from necessary stakeholders
• Facilitate and manage escalation meetings for USRC materials as needed
• Create FDA Form 2253 and coordinate with Regulatory team to complete eCTD compliant submissions to OPDP
• Provide support in managing, maintaining, and improving Veeva PromoMats functionality and training documentation
• Collaborate with management to identify USRC process efficiencies and enhancements
• Manage promotional review process associates, including contractors or consultants

Minimum Job Requirements

Qualifications

Competencies

Other Requirements

Additional Information

The base salary range for this full-time position is $135,000 - $165,000. Individual pay is determined by several factors, which include but are not limited to : job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role.

EEO

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.

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