Document Review Associate Jobs (NOW HIRING)

The Senior Promotional Review Associate (Contractor) will provide operational and coordination support to the U.S. Review Committee (USRC) process for assigned products. This role will assist with preparing promotional materials for review, facilitating meetings, maintaining documentation in Veeva PromoMats, and ensuring efficient workflow execution under the direction of USRC leadership.

This Senior Promotional Review Associate (Contractor) serves as the primary point of contact for the promotional review process and act as a liaison between Commercial Leads, Reviewers, and Agencies for assigned products. Responsibilities include ensuring materials are ready for review, editing and quality checking materials, facilitating high-quality USRC meetings, supporting planning activities, and providing training on USRC processes and Veeva PromoMats. As an integral member of the USRC team, the Contractor will provide operational and process support to help ensure timely, compliant, and efficient review of promotional materials.

• Support 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.
• Coordinate USRC activities and support the review process to help ensure efficiency and compliance.
• 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
• Perform comment verification on documents to ensure USRC advice has been incorporated correctly; follow-up with individual USRC Reviewers when further clarification is needed.
• Proofread materials for accuracy, grammar, misspellings, punctuation, formatting, and stylistic errors.
• Check materials for alignment to Brand style guide, USRC guidelines, and corporate policies.
• Provide training on USRC process and Veeva Promomats as needed.
• Coordinate logistics for USRC escalation meetings, as per USRC SOP, as needed.
• Assist with preparation of OPDP submission materials, including supporting documentation, and coordinate with the Regulatory team on final FDA Form 2253 filings.

Qualifications

• Bachelor's degree preferred.
• 3+ years of experience in equivalent or similar industry with at least 2 years of experience working with promotional review committees.
• Experience with Veeva PromoMats or similar electronic management system

Competencies

• Basic knowledge of pharmaceutical promotional regulations and submission requirements
• Experience supporting and coordinating complex projects, ensuring timelines, deliverables, and stakeholder communications are effectively handled.
• Prior experience coordinating with high performing committees or similar groups.
• Must be able to foster collaboration and teamwork while working cross functionally with stakeholders at varying levels.
• Strong organizational skills to support the management of priorities, timelines, and committee activities simultaneously.
• Excellent written and verbal communication skills to effectively convey feedback, decisions, and rationale to stakeholders.
• Ability to evaluate information, consider alternatives, and provide input or recommendations to stakeholders.
• Ability to identify and propose solutions to problems logically, quickly, and proactively.
• Exceptional attention to detail, with the ability to identify and correct errors in promotional materials, ensure accurate incorporation of reviewer comments, and maintain precise version control in Veeva PromoMats.
• Proficient in Microsoft Office, Adobe, and Veeva PromoMats

Additional Information

The hourly rate for this position is $31 - $54. 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, applicable allowances, or any additional compensation that may be associated with this role. 

You acknowledge and agree that information described herein may be disclosed to applicable regulatory authorities, alliance partners and/or third party service providers as necessary for Shionogi to fulfil its obligations under applicable laws, including but not limited to compliance with regulatory inspections and/or audits.

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.