Senior Medical Operations and Governance Specialist – Oceania and North Asia Cluster at Takeda | AU | Rezi

Senior Medical Operations and Governance Specialist – Oceania and North Asia Cluster at Takeda

Senior Medical Operations and Governance Specialist – Oceania and North Asia Cluster

Takeda · AU

1 weeks ago

Senior Medical Operations and Governance Specialist – Oceania and North Asia Cluster

Takeda · AU

10 days ago
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About the Role

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.

Responsibilities

  • Coordinate, deliver, and track Medical Affairs events and activities in Oceania.
  • Support documentation, training, audit readiness, and reporting for cluster medical governance.
  • Assess automation opportunities and associated controls for working-model integration and process optimization.
  • Act as the primary day-to-day contact for Medical Operations and Governance team for operational delivery in Oceania.
  • Coordinate operational steps for Medical Affairs activities, including intake, approval flows, contracting, logistics, payment tracking, documentation, and system close-out.
  • Support approved Medical events and maintain internal Medical team communication channels, activity trackers, calendars, and records.
  • Handle or coordinate standard contracts and renewals, supplier onboarding, third-party due diligence, purchase orders, invoice processing, travel and purchasing-account administration, and monthly OPEX reconciliation and accruals.
  • Provide first-line workflow guidance and coordinate user support for Medical Affairs systems.
  • Promote consistent governance across Taiwan, South Korea, Australia, and New Zealand.
  • Develop, implement, and adopt approved Medical procedural documents, work instructions, job aids, and training.
  • Coordinate gap assessments, audit readiness, evidence requests, and remediation tracking.
  • Monitor corrective and preventive action plans, deviations, and exceptions.
  • Document and maintain consultation and escalation pathways for market-specific input.
  • Translate approved new ways of working into practical workflows, responsibility maps, service hand-offs, user guidance, and training.
  • Evaluate process optimization opportunities based on business needs, workflow volume, data quality, technical feasibility, expected efficiency gains, and risks.
  • Support pilot testing and implementation of approved automation solutions.
  • Improve operational interfaces and reduce avoidable administrative effort.

Requirements

  • 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.
  • 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.
  • 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.
  • Ability to work effectively in a dynamic, cross-functional environment.
  • Excellent listening and decision-making skills.
  • 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.
  • Proven ability to 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.

Skills

  • Medical Affairs
  • Medical Operations
  • Medical Governance
  • Pharmaceutical Industry
  • Legal and Regulatory Requirements
  • Quality Assurance
  • SOPs
  • Audit Processes
  • Operational Reporting Tools
  • Dashboards
  • Digital Technologies
  • Emerging Technologies
  • Project Management
  • Organizational Skills
  • Event Coordination
  • Budget Tracking
  • Contract Administration
  • DocuSign
  • Building Consensus
  • Stakeholder Management
  • Adaptability
  • Influence
  • Cross-functional Collaboration
  • Listening Skills
  • Decision-making Skills
  • Written Communication
  • Verbal Communication
  • Presentation Skills
  • Teamwork

Location

  • Sydney, Australia

Work Type

  • Employee
  • Regular
  • Full time

Experience Level

  • 5 years of experience in the Pharmaceutical, Medical or Hospital Industry