*This is a senior "Head" role, with flexibility across two senior job grades for candidates who are ready to step into senior leadership, depending on experience.
**Reports in English.
About the Role
This is a senior leadership role within a newly established Medical organisation in Japan, reporting to the Head of Medical Governance.
The position is accountable for driving both efficiency and compliance across the review and approval of medical and commercial content, in line with Japanese regulatory requirements and industry standards.
The role provides visible and credible people leadership, building and developing a high-performing specialist team while embedding strong governance, risk-based decision-making and leadership behaviours across the organisation.
Set the strategic direction for medical content governance in Japan, aligning local objectives with global policies and evolving regulatory expectations.
Take overall accountability for the review and approval of promotional and non-promotional materials, ensuring alignment with scientific context, supporting evidence, and applicable laws, regulations and industry codes.
Act as a responsible officer within the relevant management and supervisory framework, overseeing risk tracking, monitoring and performance related to content and copy approval.
Design, implement and maintain governance frameworks, including KPIs and KRIs, to ensure the effectiveness and consistency of review processes.Develop and oversee a risk-based, principle-driven review strategy, prioritising resources toward higher-risk materials while ensuring consistent standards.
Lead organisational design, talent acquisition, capability development, performance management and succession planning for the content governance function.
Serve as the primary escalation and decision-making point for complex, high-risk or novel cases, coordinating with Medical, Commercial, Legal, Regulatory and global stakeholders.
Ensure robust monitoring and audit programmes are in place, reviewing findings and driving timely corrective actions and systemic improvements.Champion digital transformation and process optimisation initiatives, including workflow automation and the adoption of AI-enabled tools to enhance quality, traceability and efficiency.
Build strong stakeholder relationships across the business and represent the Japan organisation in discussions with regulators, industry bodies and global counterparts.
Promote and embed a compliance-first culture, acting as a role model for ethical decision-making and delivering training and change initiatives to reinforce expected behaviours.
Lead and develop specialists within the content governance team, enabling a collaborative and business-partnering approach while ensuring compliance standards are met.
Leadership & People AccountabilitiesProvide visible and credible leadership across the Medical organisation.
Demonstrate strong leadership behaviours, including accountability, collaboration, courage and inclusivity.
Foster a high-performing culture through talent development, constructive feedback and recognition.
Experience & Qualifications
At least 5 years of relevant experience within pharmaceuticals, biotechnology or another highly regulated environment, with progressive responsibility in areas such as medical affairs, regulatory affairs, compliance, quality or content governance.
Proven people leadership experience, including leading and scaling multidisciplinary teams, hiring, performance management, coaching, succession planning and driving organisational change.
Deep technical knowledge of pharmaceutical promotion regulations, medical governance frameworks and industry codes applicable in Japan.Hands-on experience with content and copy review processes, including SOP development and deviation management.
Strong background in governance, risk management, KPIs/KRIs and audit remediation.
Demonstrated ability to influence and partner with senior stakeholders across Medical, Commercial, Legal, Regulatory and global teams.
Experience engaging with regulatory authorities or industry bodies is preferred.
Familiarity with content management systems, workflow tools and digital transformation initiatives; openness to leveraging AI-enabled solutions.
Excellent communication skills in both English and Japanese, with the ability to produce clear guidance, training materials and executive-level reports.
Bachelor's degree required; advanced degree preferred.Strong analytical and decision-making capability, with the ability to make principled judgements in ambiguous situations.
Clear commitment to integrity, compliance and doing the right thing.
Compensation
Depends on grades, highly competitive.
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