Medical Process Excellence & Governance Lead

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The Future Begins Here

At Takeda we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities we are meeting the need of patients our people and the planet.

Bengaluru the city which is Indias epicenter of Innovation has been selected to be home to Takedas recently launched Innovation Capability Center. We invite you to join our digital transformation this role you will have the opportunity to boost your skills and become the heart of an innovative engine that is contributing to global impact and improvement.

At Takedas ICC we Unite in Diversity

Takeda is committed to creating an inclusive and collaborative workplace where individuals are recognized for their backgrounds and abilities they bring to our company. We are continuously improving our collaborators journey in Takeda and we welcome applications from all qualified candidates. Here you will feel welcomed respected and valued as an important contributor to our diverse team

OBJECTIVES/PURPOSE

• Support the realization of MGO strategy and the broader Medical Operating System by translating approved governance and operating-model requirements into clear documented and practical processes that teams can implement follow monitor and improve.
• Lead the operational design and improvement of priority Medical processes supporting the Medical Governance Office and other assigned Global Medical areas making them clear consistent and easy to follow.
• Work directly with the Head Medical Governance Office and relevant MGO capability leads to translate approved requirements into workable processes with clear steps responsibilities approvals checks handoffs documentation and escalation routes.
• Review existing ways of working remove unnecessary complexity and duplication close process gaps and coordinate the implementation of agreed improvements.
• Document and maintain the Medical execution model showing how work is carried out through end-to-end processes roles decision rights governance forums approvals handoffs systems documents measures and escalation routes.

ACCOUNTABILITIES

Make Processes Clear and Workable

• Review priority processes with the people who own and use them. Understand the current steps pain points interdependencies delays unclear responsibilities repeated work and areas where requirements are not being applied consistently.
• Support enterprise alignment on the role of vendors and digital enablers including AI within governed workflows.
• Working with MGO capability leads and accountable process owners design or update clear end-to-end processes based on approved requirements. Show what needs to happen who is responsible what decisions or approvals are required which systems and documents are used and when an issue must be escalated.
• Help global regional local and Bengaluru teams understand and adopt new or updated processes and monitor whether those processes are working as intended.
• Simplify processes wherever possible by removing unnecessary steps reducing duplication improving handoffs and clarifying responsibilities.
• Support consistent global ways of working while ensuring that valid local legal regulatory or business requirements are clearly identified and documented.
• Work with the relevant document owners and the Medical Data Governance & Knowledge Management Lead to ensure that process maps SOPs procedures templates checklists training materials and supporting guidance are aligned current and easy to find.
• Work with MGO and Medical Excellence & Operations to ensure that assigned processes align with the Medical Operating System and that gaps overlaps unclear ownership or broken handoffs are identified and addressed.
• Ensure that approved changes to processes roles governance systems or responsibilities are reflected in the Medical execution model and communicated to affected global regional local and Bengaluru teams.

Work Directly with MGO and Accountable Process Owners

• Receive functional direction from the Head Medical Governance Office on MGO priorities and expected outcomes. Agree the scope workplan deliverables timelines and escalation needs for assigned processes and reflect approved requirements in the Medical execution model.
• Partner with MGO capability leads and the accountable owner of each Medical activity to translate approved governance requirements into practical ways of working.
• Help clarify process ownership responsibilities decision points approvals and final accountability and support the agreed process design and implementation.
• Bring together the appropriate partners including Quality Ethics & Compliance Legal Privacy DD&T Finance Procurement Medical Excellence & Operations regions and local teams when their input or approval is required.
• Facilitate process discussions and working sessions document agreed decisions follow up on open actions and escalate unresolved questions to MGO or the appropriate accountable owner.

Implement and Improve Processes

• Support the introduction of new or updated processes through clear implementation plans communication training readiness checks launch support and follow-up after implementation.
• Monitor a small set of practical measures such as timeliness delays rework overdue actions exceptions user feedback and repeated process issues to understand whether each process is working effectively.
• Lead reviews of recurring process problems identify the underlying cause agree practical improvements with the responsible owners and track those improvements through completion.
• Identify opportunities for simple workflow tools or automation where they will reduce manual effort improve consistency or make the process easier to follow. Partner with DD&T and system owners on any technology changes.

DIMENSIONS AND ASPECTS

Technical/Functional Expertise

• Strong understanding of how to review design document implement and improve end-to-end processes in a regulated environment.
• Good knowledge of Medical Affairs operations and governance processes including the relationship between policies SOPs procedures roles approvals systems records training and day-to-day execution.
• Good understanding of operating models and execution models including how roles decision rights governance forums processes systems measures and handoffs work together.
• Ability to take complex or unclear requirements and turn them into simple practical ways of working that people can understand and follow.
• Understands the difference between designing and supporting a process and owning the final governance scientific compliance legal financial or business decision.

Leadership

• Leads cross-functional discussions and helps stakeholders reach clear and practical decisions.
• Constructively challenges unnecessary complexity unclear responsibilities inefficient ways of working and repeated activities.
• Influences stakeholders across functions and geographies without relying only on formal authority.
• Maintains momentum by ensuring that decisions are documented responsibilities are clear and agreed actions are completed.

Decision-Making and Autonomy

• Accountable for the operational approach used to review design document implement and improve processes within the approved scope.
• Makes recommendations on how a process should work how responsibilities should be divided and how operational process issues should be resolved.
• Makes operational decisions within approved governance requirements and agreed decision boundaries.
• Escalates decisions that involve governance direction policy interpretation Medical or scientific judgment Quality Ethics & Compliance Legal Privacy Finance technology ownership or business accountability.
• Final governance requirements and decisions remain with MGO or the relevant accountable functional owner.

Interaction

• Works directly with the Head Medical Governance Office and relevant MGO leads to translate approved MGO requirements into the documented Medical execution model and practical ways of working monitor progress and escalate significant process issues.
• Works closely with MGO capability leads and the accountable owners of Medical activities to design implement and improve the processes supporting their areas.
• Maintains close alignment with the GCM Medical Operations & Governance Lead as the formal line manager and regarding Bengaluru priorities resources and cross-team dependencies.
• Partners closely with the Medical Data Governance & Knowledge Management Lead to ensure that process documents definitions records and supporting knowledge remain aligned.
• Collaborates with Audit Inspection Readiness & Risk Management Medical Excellence & Operations Quality Ethics & Compliance Legal Privacy DD&T Finance Procurement and global regional and local Medical teams.

Innovation

• Looks for practical ways to make processes easier faster and more consistent.
• Uses digital tools workflow solutions automation and AI-enabled capabilities where they solve a clear process need and can be introduced with appropriate controls and oversight.
• Avoids automating an unclear or unnecessarily complex process before the process itself has been clarified and simplified.

Complexity

• Works across different Medical activities functions systems regions and local organizations.
• Balances the need for consistent global processes with valid local legal regulatory or business requirements.
• Manages situations where responsibilities requirements or handoffs may initially be unclear and helps the appropriate owners reach agreement.
• Supports consistent implementation without taking ownership of governance strategy policy requirements or the final decisions of MGO and other accountable functions.

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS

Education

• Bachelors degree in life sciences business operations quality healthcare administration engineering or a related discipline is required.
• An advanced degree or relevant certification in process improvement change management quality or project management is preferred but not required.

Experience

• Eight or more years of relevant professional experience including at least four years in the biopharmaceutical healthcare or another regulated industry.
• Experience reviewing designing improving or implementing cross-functional processes.
• Experience in Medical Affairs operations Medical governance quality compliance business operations process improvement or a related area.
• Experience working with global regional and local stakeholders in a matrixed organization.
• Experience supporting the implementation of new processes organizational change centralization or the transition of activities to a global capability center is preferred.
• Experience leading cross-functional work projects or senior individual contributors is preferred.

Skills

• Ability to understand and clearly describe an end-to-end process.
• Ability to identify unnecessary steps duplication delays unclear responsibilities missing checks and difficult handoffs.
• Ability to create clear process maps role descriptions procedures templates checklists training materials and implementation plans.
• Strong facilitation skills and the ability to guide stakeholders toward clear and practical decisions.
• Strong problem-solving skills and the ability to turn recurring issues into practical improvements.
• Ability to use simple measures and stakeholder feedback to assess whether a process is working effectively.
• Strong written and verbal communication skills including the ability to explain complicated topics in clear language.

Behavioural Competencies

• Practical and solutions-oriented with a strong focus on making processes usable for the people who need to follow them.
• Comfortable asking questions challenging unnecessary complexity and clarifying unclear responsibilities.
• Collaborative and respectful while able to hold stakeholders accountable for agreed decisions and actions.
• Organized reliable and able to follow work through from initial review to implementation and ongoing improvement.
• Demonstrates sound judgment and knows when a question must be escalated to MGO or another accountable function.

Languages

Fluent English required; additional languages advantageous.

ADDITIONAL INFORMATION

• Formal line reporting is to the GCM Medical Operations & Governance Lead.
• For MGO-assigned scope the role works directly with the Head Medical Governance Office who provides functional direction on priorities approved requirements expected outcomes workplans and escalation of significant process matters.
• The role supports the realization of MGO strategy and the Medical Operating System by turning approved governance and operating-model requirements into the documented Medical execution model and clear practical processes; coordinating implementation; monitoring how processes work; and leading agreed improvements.
• MGO and the relevant accountable process owners retain responsibility for governance direction policy requirements and final business or functional decisions.
• The role does not replace the responsibilities of Quality Ethics & Compliance Legal Privacy Finance DD&T Audit and Inspection Readiness or other accountable functions.
  

BENEFITS:

It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:

• Competitive Salary Performance Annual Bonus

• Flexible work environment including hybrid working

• Comprehensive Healthcare Insurance Plans for self spouse and children

• Group Term Life Insurance and Group Accident Insurance programs

• Employee Assistance Program

• Broad Variety of learning platforms

• Diversity Equity and Inclusion Programs

• Reimbursements Home Internet & Mobile Phone

• Employee Referral Program

• Leaves Paternity Leave (4 Weeks) Maternity Leave (up to 26 weeks) Bereavement Leave (5 calendar days)
  

ABOUT ICC IN TAKEDA:

• Takeda is leading a digital revolution. Were not just transforming our company; were improving the lives of millions of patients who rely on our medicines every day.

• As an organization we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.

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