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About the Role
This role is responsible for managing review governance and related processes in Japan. It involves ensuring all communications comply with company policies, ethical standards, and regulatory guidelines, while also managing relationships with promotional partners and driving continuous improvement in review processes.
Responsibilities
- Manage review governance and related processes in Japan.
- Serve as an approver in the Country Clearance Committee (CCC) process.
- Ensure all reviewed and approved communications comply with company policies, UCB Code of Conduct, laws, regulations, and MHLW guidelines.
- Oversee the smooth operation of the CCC.
- Ensure efficient and effective processes for review, update, approval, archiving, and expiration management under the Medical Integrity philosophy.
- Manage and serve as the point of contact for joint promotional partner companies.
- Ensure partner company processes align with UCB Japan's standards.
- Provide high-quality training to UCB Japan employees on review governance.
- Propose and build new mechanisms, systems, and processes for review governance.
- Manage and overcome challenges, including compliance with the latest MHLW guidelines.
- Develop and revise SOPs, related instructions, and forms for proper review governance execution.
- Support the Operation Management Lead and the Head of Medical Operations.
- Execute tasks under the direction and prioritization of the Operation Management Lead, maintaining CCC review operations while performing governance activities.
- Collaborate closely with supervisory and related governance departments to ensure consistency in review governance processes, audit readiness, and risk reduction across the organization.
- Act as the central point of contact for internal and external audits and inspections related to CCC review governance, preparing supporting documents and coordinating responses.
- Lead the CAPA cycle for review governance findings, including root cause analysis, corrective and preventive actions, and effectiveness verification, reporting progress to management.
- Drive continuous improvement through KPI analysis (e.g., review volume, cycle time, compliance status) and reflect findings in standardized templates, checklists, and training materials.
- Advise the Medical and related departments on planning and executing medical activities efficiently while ensuring compliance and alignment with review requirements and governance standards.
- Oversee the governance aspects of non-promotional activities, including Scientific Grants, ensuring alignment with company policies, regulations, and transparency requirements.
- Ensure the CCC review and approval process for local and global communications is properly managed according to company policies and the UCB Code of Conduct.
- Ensure all communications comply with local laws, regulations, and guidelines, applying stricter standards where UCB policies differ from local regulations.
- Ensure all communications are reviewed and approved within deadlines in the electronic approval system and assigned unique identification codes.
- Ensure approved communications and related evidence are archived in the electronic approval system for at least five years.
- Ensure approved communications are appropriately updated due to changes in添付文書, safety information, regulations, litigation, or requests from GCC/CCC.
- Ensure expiration dates are managed appropriately based on CCC requirements.
- Contribute to the development of company response strategies through timely collaboration with internal and external stakeholders.
- Provide high-quality training to UCB Japan employees in collaboration with Ethics & Compliance (E&C) and Legal teams.
- Ensure consistency in compliance standards, audit readiness, and risk management methodologies in collaboration with supervisory and related governance organizations.
- Serve as a liaison between Operation Management and supervisory departments for smooth communication, reporting, and issue escalation.
- Ensure recommendations and requirements from supervisory departments are appropriately reflected in CCC review procedures and SOPs.
- Establish and maintain escalation routes for complex 'grey area' cases, promoting collaboration with relevant departments (Medical, Regulatory, Legal, E&BI) and documenting decisions for consistency.
- Be responsible for the regular maintenance of CCC review governance SOPs and related procedures in alignment with global requirements (managing review cycles, gap analysis, updates, and dissemination).
- Oversee audit and inspection readiness, preparing evidence packages (sampling, approval rationale, identification codes) and managing CAPA completion for audit findings.
- Establish and operate a systematic training and feedback cycle (e.g., consolidating frequent findings, updating reviewer guidance, revising applicant checklists, conducting refresher training with E&BI and Legal).
- Monitor, analyze, and report on review KPIs (volume, lead time, rework, timeliness) and propose process simplification/standardization through risk-based approaches and template utilization.
- Continuously perform assigned CCC review tasks (material review, slide review, approval flow participation, timely completion) while upholding governance responsibilities.
- Advise Medical and related departments from the planning stage of medical activities (material creation, event organization, speaker invitations) to ensure compliance and review readiness.
- Support stakeholders in early identification of potential compliance risks and development of appropriate risk mitigation measures.
- Advise on efficient review pathways (risk-based approach, determining necessary review levels) to shorten review times and optimize resource utilization.
- Ensure appropriate governance and compliance for non-promotional funding activities, including Scientific Grants (coordinating reviews, document management, alignment with company standards and regulations).
- Ensure consistent application of policies and operational processes for non-promotional activities in collaboration with Medical, Compliance, and Legal departments.
- Support compliance with transparency requirements for grants and funding, ensuring alignment with reporting requirements as needed.
Requirements
- 5+ years of experience in material review within the pharmaceutical industry or with pharmaceutical vendors.
- Experience leading compliance reviews of medical communications (promotional, educational, publications) for internal and external use.
- Deep understanding of global/local policies, procedures, guidelines, and regulations, with experience managing medical information inquiry functions.
- Experience in Medical or Compliance/Governance.
- Experience participating in domestic or global audits from a Medical or Compliance perspective.
- Internal applicants must have been in their current role for at least 12 months, meet performance standards, and have no formal corrective or disciplinary actions in the past 12 months.
- Consult with your manager or talent partner before applying for internal positions.
Skills
- Review Governance
- Process Management
- Compliance
- Regulatory Affairs
- Medical Communications
- Auditing
- Risk Management
- Training
- SOP Development
- CAPA Management
- KPI Analysis
- Stakeholder Management
- Cross-functional Collaboration
Location
- Japan
Work Type
- Full-time
Experience Level
- SA I
About the Company
- UCB is committed to equal opportunities in employment.
- All hiring decisions are made regardless of any legally protected attribute.
Equal Opportunity
- UCB is committed to equal opportunities in employment. All hiring decisions are made regardless of any legally protected attribute.
- If you require special accommodations during the selection process to fully utilize your strengths and abilities, please contact EMEA-Reasonable_Accommodation@ucb.com. Please note that this contact is only for consultations regarding special accommodations in the selection process.