Senior Medical Operations and Governance Specialist – Oceania and North Asia Cluster
Takeda · Sydney
Job Description
The Medical Operations and Governance Specialist provides day-to-day operational support to Medical Affairs in Oceania and contributes to medical governance and process optimization across the North Asia and Oceania cluster. The role supports ethical and compliant delivery in accordance with company standards and applicable legal and regulatory requirements. In collaboration with the Cluster Medical Operations and Governance Lead and team colleagues, the role integrates approved ways of working into daily practice and identifies opportunities to improve efficiency while maintaining appropriate controls.
The role includes responsibility for:
- Oceania Medical operations, including the coordination, delivery and tracking of Medical Affairs events and activities to support high-quality, compliant execution of Medical Affairs plans.
- Cluster medical governance, including support for documentation, training, audit readiness and reporting in accordance with applicable global, regional and market requirements.
- Working-model integration and process optimization, including assessment of automation opportunities and associated controls.
Key accountabilities
A. Oceania Medical operations (approximately 70–80% of working time)
· Act as the principal day-to-day Medical Operations and Governance team contact for internal Medical Affairs operational delivery in Oceania, coordinating workflows with business owners and local cross-functional partners.
· Coordinate and execute operational steps for Medical Affairs activities, such as medical education, advisory boards, grants, sponsorships and team meetings. Activities include intake, coordination of the required approval flows, contracting, logistical arrangements, payment tracking, documentation and system close-out.
· Support approved Medical events and maintain internal Medical team communication channels, activity trackers, calendars and accurate supporting records; confirm delivery owners and promptly escalate delayed, incomplete or higher-risk items.
· Handle or coordinate standard contracts and renewals; supplier onboarding and third-party due diligence; purchase orders and invoice processing; travel and purchasing-account administration; and monthly OPEX reconciliation and accruals.
· Provide practical first-line workflow guidance and coordinate user support for systems used in Medical Affairs activities.
B. Cluster Medical governance (within the combined 20–30% cluster allocation)
· Collaborate with the Cluster Medical Operations and Governance team to promote consistent governance across Taiwan, South Korea, Australia and New Zealand while accommodating market-specific requirements.
· Development, implementation and adoption of approved Medical procedural documents, work instructions, job aids and training with designated document and market owners; maintain clear version control, market applicability and evidence of adoption.
· Coordinate assigned gap assessments, audit readiness, evidence requests and remediation tracking; monitor corrective and preventive action (CAPA) plans, deviations and exceptions, and escalate overdue actions to authorized functional owners.
· Document and maintain consultation and escalation pathways for market-specific input from Legal, Quality, Ethics & Compliance, Privacy, Pharmacovigilance and Finance on cross-market process changes.
C. Working-model integration and risk-balanced process optimization (within the same 20–30% cluster allocation)
· Translate approved new ways of working, such as global capability centers where adopted, into practical workflows, responsibility maps, service hand-offs, user guidance and training, with particular attention to Oceania operations and interfaces across the cluster.
· Evaluate process optimization opportunities based on business needs, workflow volume, data quality, technical feasibility, expected efficiency gains and financial, quality, compliance and privacy risks.
· Support pilot testing and implementation of approved automation solutions; define requirements for human review, exception handling, access controls, audit trails, control validation and ongoing monitoring.
· Collaborate with internal cross-functional partners to improve operational interfaces and reduce avoidable administrative effort, enabling Medical teams to focus on higher-value scientific and strategic work.
Experience and Capabilities
- Demonstrated understanding of the purpose of Medical Affairs, medical operations, and the importance and scope of medical governance.
- Demonstrated understanding of the business context and legal and regulatory requirements relevant to the pharmaceutical industry and Medical Affairs engagements.
- Ability to coordinate governance processes across markets, working with authorized local owners to support compliance with company policies and applicable requirements.
- Knowledge of quality assurance practices and the ability to promote adherence to SOPs and regulations.
- Ability to support audits, track progress and coordinate remediation activities with designated owners; knowledge of audit processes and standards relevant to Medical Affairs.
- Experience using operational reporting tools, dashboards and digital technologies to improve workflows, with an aptitude for adopting emerging technologies where appropriate.
- Strong project-management skills to support timely execution of Oceania Medical Affairs plans and assigned cluster governance and process-improvement initiatives.
- Strong organizational skills to coordinate medical events such as advisory boards and educational meetings.
- Expertise in scheduling and coordinating meetings and events, including logistical arrangements for invitations, speakers, travel and hospitality.
- Budget tracking and management skills to ensure cost-effective event planning.
- Ability to prepare and manage event-related materials and documentation.
- Experience coordinating contract administration, including preparation and routing for execution using tools such as DocuSign.
- 5 years of experience in the Pharmaceutical, Medical or Hospital Industry
Enabling Capabilities
- Ability to build consensus across multiple functional stakeholders.
- Ability to manage complex situations and diverse stakeholders and quickly adapt to changing business needs and priorities.
- Ability to influence others in a matrix setting to achieve alignment and consensus and to work effectively in a dynamic, cross-functional environment.
- Excellent listening and decision-making skills, as well as strong written, verbal and presentation skills.
- Clear, professional and articulate communication skills.
- Self-motivated and results-oriented.
- Proven ability to work effectively as part of a team and build credibility and confidence internally and externally.
- High integrity and an ethical, professional mindset.
- A proven track record of teamwork, leadership and timely decision-making.