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Director Global Regulatory Tracking

Eingestellt von Bio Careers

Gesuchte Skills: Support, Library

Projektbeschreibung

TAKEDA PHARMACEUTICAL has a booth in the Employers Hall at the Virtual Job Summit. Go to the booth to see Brochures, White Papers, Videos and other information. You may also be able to Video Chat with a recruiter on October 3, 2PM - 5PM EST and October 4, 2PM - 4PM EST and 4:30PM - 6:30PM EST. You can Register for the Job Summit here.
OBJECTIVES:

The global regulatory tracking database supports the overview over all Takeda's products and registrations worldwide and supports the tracking of all key regulatory activities, follow-up commitments etc. The database is also providing products and registration data to the EudraVigilence Medicinal Product Dictionary (EVMPD) database in Europe and is used by Global Pharmacovigilance as well as global Productions functions.

This position is responsible for the administration, ongoing development, maintenance and support of the global Regulatory tracking databases and also holds line management responsibility for the global Regulatory tracking support organization based in Roskilde, Osaka and Deerfield.

The role is expected to advocate e-working, explore and drive implementation of new features/software to meet business needs and act as an interface between IT, business users and external software providers (as relevant).

This position will ensure that Takeda is aware and responsive to external guidelines and regulations as they pertain to regulatory tracking, e.g. oversight of products and registrations, XEVMPD etc.

ACCOUNTABILITIES:

User Support

- - Provide and oversee support of all global users understanding and ensuring their needs are met
- - Expert in tracking databases functionality, plan, manage and deliver end user training
- - Support the creation and development of training materials
- - Support the creation of 'quick reference guides' describing system related business processes
- - Administer user accounts and ensure appropriate access control/permissions
- - Support codelists/library creation and management
- - Partner with IT to appropriately triage and troubleshoot tickets taking responsibility for prioritizing and resolving business process related issues
- - Partner with global functional leads and users to advocate and promote e-working as best practice
- Partner with global functional leads to influence and advise on the use of the global regulatory tracking in daily business processes

System Compliance and Development

- - Ensure compliance and timely submission of data to EVMPD
- - Analyze user support tickets to identify system issues, trends, training issues and need for system changes
- - Oversee the update and management of all regulatory tracking information/access sites/portals including the global labeling database
- - Partner with IT and QA to ensure the system is maintained in a validated state
- - Responsible for the PQ validation of the system
- - Maintain awareness of change request development, ensure appropriate communication and Business change management efforts to global regulatory tracking users on changes and support implementation through informal and formal testing and training as appropriate
- - Influence global strategy for the continued evolution of the regulatory tracking database in alignment with external requirements as well as the organizations current and future needs
- Participate in global projects for system development and maintenance

Leadership

- - Responsible for the personal and professional development of global Regulatory Tracking support organization (permanent and contractor) based in Roskilde, Osaka and Chicago
- - Ensure the development of core competencies and measurement of performance (according to national law) against departmental goals and expectations
- Prepare and monitor budgets for the group as appropriate

Environmental Awareness

- - Maintain an expert, current knowledge of regulations, legislation, best practices and guidelines relating to regulatory tracking and GxP, Annex 11 and 21 CFR Part 11 validated systems
- - Represent Takeda at relevant Industry Forums e.g. Register user groups
- Maintain appropriate professional memberships e.g. TOPRA, DIA

Projektdetails

  • Einsatzort:

    Deerfield, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Bio Careers