Regulatory Affairs Analyst Pharmaceutical
Aviso de fuente externaen Genpact
Genpact seeks a Translation management, artwork review and change management Analyst to implement DCI changes in the SCF and review approved artwork.
Salario
No especificado
Ubicación
Heredia, Costa Rica
Tipo de empleo
Tiempo completo
Modalidad
No especificado
Regulatory Affairs Analyst Pharmaceutical
Heredia, Costa Rica
Descripción del empleo
About the role
Genpact is inviting applications for a Translation management, artwork review and change management Analyst. The role ensures that changes required through DCIs are properly implemented in the SCF and match the approved artwork.
Responsibilities
- Ensure changes required through DCIs are properly implemented in the SCF, with no differences against the approved artwork.
- Ensure SCF changes are related to LRAM’s DCI request and that additional changes received in SCF comply with the regulation.
- For multi-country presentations, evaluate the impact of changes on the countries involved and, if applicable, align alternative solutions with the LRAMs of the affected countries.
- Develop the implementation plan together with the LCM.
- Use software and systems such as SAP, Veeva Vault and TVT Backup.
Datos clave
- The role is with Genpact in Heredia, Costa Rica.
- The role involves implementing DCI changes in the SCF and checking them against approved artwork.
- The work includes evaluating changes for multi-country presentations.
- The listed systems include SAP, Veeva Vault and TVT Backup.
Preguntas frecuentes
What does the role involve?
It involves implementing changes required through DCIs in the SCF and ensuring there are no differences from approved artwork.
What systems are used?
The listing mentions SAP, Veeva Vault and TVT Backup.
What does the role cover for multi-country presentations?
It includes evaluating the impact of changes on the countries involved and, if applicable, aligning alternative solutions with the LRAMs of affected countries.