Senior Manager, Non-Promotional Review Committee

Title:

Senior Manager, Non-Promotional Review Committee

Company:

Ipsen Biopharmaceuticals Inc.

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

Senior Manager, Non-Promotional Review Committee

Summary & Purpose of the Position

The Senior Manager, Non-promotional Review Committee will be responsible for coordinating the US Medical Review Committee (MRC) process and overseeing the full span of MRC review, ensuring overall process excellence for the portfolio. This role will lead MRC teams to consensus while achieving materials approval deadlines, facilitate escalation meetings as needed, and work with stakeholders to optimize outcomes. The Senior Manager will ensure all materials comply with and are approved in accordance with the MRC SOP and industry best practices/regulations, paying close attention to detail while proofing materials. Additionally, the role involves capturing and tracking efficiencies and review excellence KPIs, measuring the effectiveness of the process through analytics and reporting.

Main Responsibilities & Technical Competencies

• Oversee the management and forecasting of materials across all MRC teams:

  • Ensure a clear understanding of the MRC process through onboarding and routine training of teams, including sponsors, reviewers, and agency partners.
  • Manage the balance of live meeting time across MRC teams, developing and updating annual, quarterly, monthly, and weekly MRC plans.
  • Oversee adherence to timelines for submission and review of materials in MRC, with the goal of minimal expedited or escalated reviews.
  • Partner with other MRC coordinator(s) and PRC coordinators to achieve full visibility into materials review scope and reviewer workloads.
• Facilitate MRC materials review for assigned product(s): Lead planning and implementation of MRC operations:
  • Ensure materials meet established criteria prior to being circulated to reviewers through electronic review system (e.g., Veeva PromoMats)
  • Move materials through the workflow in accordance with established timelines.
  • Facilitate efficient meetings and focus on key issues, with the goal of bringing the group to consensus, including escalation meetings where necessary.
  • Ensure all reviewer comments on materials are clarified, reconciled, and incorporated prior to final approval of materials.
  • Coordinate with sponsors to monitor the Archival and Expiry of Materials in accordance with relevant SOPs.
  • Partner with system owners to manage the electronic review system and related functionalities, including managing access to the system.
  • Serve as a key stakeholder in updates to process and system enhancements related to materials review.
  • Facilitate development and maintenance of the MRC materials, including SOPs, standard language/disclaimers, submission guides, reference documents, and training materials.
  • Act as a subject matter expert for the review process, including technical knowledge related to the system and process steps/roles and responsibilities within relevant SOPs.
  • Ensure responsibilities listed in the global non-promotional materials