Medical Process Excellence & Governance Lead
Takeda · Bengaluru
Job Description
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 India’s epicenter of Innovation, has been selected to be home to Takeda’s recently launched Innovation Capability Center. We invite you to join our digital transformation journey. In 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 Takeda’s 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
- Bachelor’s 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. We’re not just transforming our company; we’re 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.
#Li-Hybrid