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About the Role

Primarily responsible for the review governance and processes in Japan. Work for Country Clearance Committee (CCC) as one of local signatories of CCC process. Make sure that all communications reviewed and approved are within the set expectation in line with company policies, UCB code of standards, local laws, regulations, and guidelines such as MHLW new guidelines. Control the good operation for CCC. Ensure efficient and effective review, update, approval, archiving, and expiration management processes are in place within Medical Integrity. Interface and manage co-promotion partner companies in Medical Integrity. Ensure sales partners’ processes are aligned to the UCB Japan’s expectations. Provide high quality trainings to UCBJ staff. Propose and establish new mechanisms, systems, and processes for the review governance. Manage and overcome facing challenges such as MHLW new guidelines. Ensure SOPs, associated instructions, and forms for the material review governance are established and revised for adequate executions. Support Lead and Head. Work under the direction and prioritization of the Operation Management Lead; execute governance activities based on Lead’s instructions while maintaining CCC review delivery. Works closely with supervising office and relevant governance functions to ensure alignment of review governance processes, audit readiness, and risk mitigation strategies across the organization. Serve as the central point of contact for audit readiness and inspection response for CCC-related review governance (internal/external), including evidence preparation and response coordination. Lead CAPA lifecycle for review governance findings (root cause, corrective/preventive actions, effectiveness checks) and provide periodic status updates to Operation Management Lead/ Head of Medical Operations. Drive continuous improvement by analyzing KPIs (volume, cycle time, compliance Status) and translating insights into standardized templates, checklists, and training content for submitters/reviewers. Provide advisory support to Medical and cross-functional teams on compliant and efficient planning of medical activities, ensuring alignment with review requirements and governance standards. Oversee governance aspects of non-promotional activities including scientific grants, ensuring alignment with company policies, applicable regulations, and transparency requirements.

Responsibilities

Ensure the CCC is in place for review and approval of local communications and local adaptations of global communications in accordance with company policies, UCB code of standards for Promotional (sop-ai-008517) or Educational (sop-ai-008518) or Press Communications (sop-ai-012672).
Ensure that all communications comply with local laws, regulations, and guidelines as well and that the stricter applies in case of conflict with the UCB Policies and UCB codes of standards.
Ensure that all communications are reviewed and approved in the electronic clearance system within timelines, and that a unique identifier code is provided to each approved communication as defined locally.
Ensure archiving for a minimum of 5 years of the reviewed and approved communication as well as evidences using the electronic clearance system.
Ensure that the approved communications are updated in case of a change in label, safety issue, change in regulation, litigation, or any other change requested by GCC or CCC members.
Ensure expiration date is defined according to CCC requirements and expiration status is managed.
Contribute to the company's response and setting of direction through timely collaboration and consultation with internal and external stakeholders.
Provide high quality trainings to UCBJ staff, based on good collaboration with E&C/Legal team.
Collaborate with supervising office and relevant governance bodies to ensure alignment on compliance standards, audit readiness, and risk management approaches.
Act as liaison between Operation Management and supervising office to facilitate communication, reporting, and issue escalation.
Ensure that recommendations and requirements from supervising office are appropriately integrated into CCC review processes and SOPs.
Establish and maintain escalation pathways for “grey-zone” cases; facilitate cross-functional alignment (Medical/Regulatory/Legal/E&BI) and document decisions to ensure consistency.
Own periodic SOP/associated instruction maintenance for CCC review governance (review cycle, gap identification between SOP and operation, updates and communication) in alignment with global requirements.
Coordinate audit/inspection readiness: maintain an evidence package (sampling of approvals, rationale, identifiers, archiving/expiration controls) and manage CAPA closure for audit observations.
Implement a structured training & feedback loop: consolidate frequent findings, update reviewer guidance/submitter checklists, and deliver refresh training in collaboration with E&BI/Legal.
Monitor and report review KPIs (review volume, lead time, rework cycles, overdue rate) and propose process simplification/standardization (risk-based routing, template reuse) without compromising compliance.
Continue to perform CCC review tasks as assigned (material/speaker slide review, approval workflow participation, and timely review completion) while taking on governance responsibilities.
Provide consultation to Medical and cross-functional stakeholders during the planning phase of medical activities (e.g., materials, events, speaker engagements) to ensure compliance and review readiness.
Support stakeholders in proactively identifying potential compliance risks and defining appropriate mitigation strategies.
Advise on efficient review pathways (e.g., risk-based approach, required level of review) to optimize review timelines and resource utilization.
Ensure appropriate governance and compliance for scientific grants and non-promotional funding activities, including review oversight, documentation, and alignment with company standards and applicable regulations.
Collaborate with relevant functions (Medical, Compliance, Legal) to ensure consistent application of policies and processes for non-promotional activities.
Support transparency obligations related to grants and funding, ensuring alignment with reporting requirements where applicable.

Requirements

Internal applicants must have been in their current role for at least 12 months.
Must meet performance evaluation criteria.
Must not have received formal corrective actions or disciplinary actions (e.g., Performance Improvement Program (PIP), warning, final warning, compliance-related warning letter) within the last 12 months.
Consult with your manager or talent partner before applying for internal positions.

Experience Level

SA I

Education Level

Bachelor's Degree
Master's Degree

About the Company

UCB is committed to equal opportunity.
All hiring decisions are made regardless of any legally protected characteristic.
If you require special accommodation during the selection process to showcase your strengths and abilities, please contact the following email address: EMEA-Reasonable_Accommodation@ucb.com
Please note that this contact point is only for consultation regarding special accommodations in the selection process and not for other inquiries.

Equal Opportunity

UCB is committed to equal opportunity.
All hiring decisions are made regardless of any legally protected characteristic.