Shionogi Inc. (U.S.) is hiring: Senior Manager, Promotional Review Process Lead,

Overview

Senior Manager, Promotional Review Process Lead, USRA- Advertising & Promotion at Shionogi Inc. (U.S.). The Senior Manager will oversee all aspects of the commercial US Review Committee (USRC) process and serve as the primary contact for the promotional review process. This role acts as a liaison between Commercial Leads, Reviewers, and Agencies for assigned products.

Responsibilities

• Lead and manage the end-to-end review and approval lifecycle of promotional materials, utilizing the electronic review system, Veeva PromoMats.
• Collaborate cross-functionally with Commercial, Regulatory, Legal, Medical, and Agency partners.
• Coordinate USRC activities to ensure the promotional review process is conducted in a compliant and efficient manner.
• Facilitate high-quality USRC meetings, including agenda planning, time management, and accurately capturing consensus comments at live reviews.
• Review submissions for completeness and quality before circulation to reviewers; provide proactive guidance as needed.
• Work 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 on workflow issues.
• Monitor document lifecycle, including reapprovals and expiry, in accordance with USRC SOP.
• Assist 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 processes and systems, including new hires and refresher training; update training materials as needed.
• Lead process improvement initiatives and collaborate with the USRC team to share ideas and support team growth.
• Track USRC reviewer comments and coordinate necessary revisions from stakeholders.
• Facilitate and manage escalation meetings for USRC materials as needed.
• Create FDA Form 2253 and coordinate with Regulatory to complete eCTD submissions to OPDP.
• Support maintenance and improvement of Veeva PromoMats functionality and training documentation.
• Identify USRC process efficiencies and enhancements in collaboration with management.
• Manage promotional review process associates, including contractors or consultants.

Minimum Job Requirements

Qualifications

• Bachelor’s degree preferred
• 5+ years of experience in a related industry with at least 2-3 years of experience working with promotional review committees
• Experience with Veeva PromoMats or a similar electronic management system

Competencies

• Basic knowledge of pharmaceutical promotional regulations and submission requirements
• Experience managing complex projects with timelines, deliverables, and stakeholder communications
• Prior experience coordinating with high-performing committees or similar groups
• Ability to foster a collaborative, cross-functional team environment
• Strong organizational skills to manage multiple projects and timelines
• Excellent written and verbal communication to convey feedback and decisions
• Ability to evaluate information, consider alternatives, and make informed recommendations
• Problem-solving, proactive, and detail-oriented
• Proficient in Microsoft Office, Adobe, and Veeva PromoMats

Other Requirements

• Must live within commutable distance to US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month

Additional Information

The base salary range for this full-time position is $135,000 - $165,000. Individual pay is determined by factors including job-related skills, experience, and education. The range does not include benefits, bonus, or additional compensation.

EEO

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, disability, or other protected characteristics. Applicants may request a reasonable accommodation if unable to use or access this website due to disability by calling 973-307-3550 or emailing ShionogiHR@shionogi.com.