Gra Mpd Epic Associate Director

vor 8 Monaten

Zurich, Schweiz Takeda Vollzeit

Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?**
- OBJECTIVES/_PURPOSE_ _
- Provides strategic and tactical advice to internal and external teams to achieve timely and efficient maintenance of programs, while ensuring compliance with applicable regulatory requirements
- Partners with internal stakeholders and external vendor partners such as GPSE, Global Labeling, Global CMC, Local Operating Companies and Supply Chain on matters related to MPD (Marketed Products Development) EPIC portfolio
- Ensures successful and effective oversight of the vendor management model by defining the strategy, overseeing regulatory activities for designated portfolio of products, and resolving and escalating issues as necessary
- Is a leader both internally and externally, contributing to cross-functional initiatives and influencing the field as applicable
- Responsible for providing support and assistance to the Director, GRA MPD, EPIC Lead with leadership and oversight for all strategically sourced activities related to portfolio
- Primary point of contact for a designated portfolio of products that are vendor managed
- A_CCOUNTABILITIES_ _
- Supports an outsourcing vision to achieve current and future business objectives and ensure that external team is continuously optimized in performance and deliverables
- Ensures clear and timely communication related to activities to internal and external stakeholders
- Drives and manages activities related to MPD portfolio of responsibility to successful completion
- Escalates issues/problems to oversight team or MPD portfolio cross-functional lead, as appropriate
- Responsible for demonstrating Takeda leadership behaviors
- In coordination with regulatory leads, provides strategic guidance / advice on regulatory trends, regulations, and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs
- Develops effective working relationships with regulatory team, cross-functional teams; company’s consultants and business partners
- Mentors other Takeda team members, if required, to support scope of project work
- CORE_ ELEMENTS RELATED TO THIS ROLE_
- Excellent communication, organizational, and team collaboration skills
- Must work effectively with global associates and local operating companies, demonstrating strong interpersonal skills combined with cultural sensitivity
- Ability to interact effectively between customers and suppliers, and to manage and resolve issues, and to provide effective feedback
- Must be able to handle multiple projects simultaneously while maintaining high quality results
- DIMENSIONS AND ASPECTS_

**Technical / Functional (Line) Expertise**
- Knowledge of business and regulatory environment, and ability to identify and proactively manage the interactions necessary for achieving the business goals and objectives
- Awareness of global health authorities, regulations, product approvals, lifecycle processes for global markets, pharmaceuticals/devices, and regulatory affairs requirements and processes
- Excellent analytical, technical, and strategic problem-solving skills
- Project management abilities

**Leadership**
- Compatible working across functions, regions, and cultures
- Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
- Proven skills as an effective team leader who can engender credibility and confidence within and outside the company
- Ability to distill complex issues and ideas down to simple comprehensible terms
- Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
- Influence others at all levels and works collaboratively across different Global functions and Business Units (BU)
- Strong ability to recognize and consider interdependencies of requirements and changing needs of a fast paced and dynamically complex business, translate solutions, communicate the risks, mitigation plans, and issues resolutions to a senior level and program team members
- Works collaboratively in a cross-functional team environment, across multiple time zones

**Decis**ion-making** and Autonomy**
- Ability to strategize, communicate and resolve issues independently
- Self-motivated, self-starter with the ability to work independently and in a team with a flexible mindset
- Independently manage product workload and coordinates with stakeholders to ensure timely completion of product work deliverables
- Forward thinker with the ability to recommend, influence and implement organizational change and continuous innovation
- Take initiative and coordinate resources to drive tasks to deadlines
- Demonstrate technical and solutioning skills, influence decision making to feasible solutions
- Use collaboration skills and partnerships to work within the agreed Governance model

**Interaction**
- Efficiently/actively manage conflict in a tactf

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