Administrative Specialist
Job Description:
Provide comprehensive administrative support to managers, including handling confidential information with discretion and assisting with special projects. Ensure the efficient organization and maintenance of the department’s filing system, including confidential data. Offer clerical support as needed, including filing tasks. Perform additional duties as required.
Responsibilities:
- Serve as the primary contact for training support and troubleshooting for the BIRDS system within the team.
- Keep the team updated on new BIRDS developments, system updates, and relevant information.
- Collaborate with the DRA Manager of the EU Regional Archiving Center to design workarounds and best practices for the archiving process.
- Communicate with other Key Users and LBACs to exchange vital information as the BIRDS system is implemented and refined across the Human Pharma community.
- Escalate unresolved issues to the appropriate Global Business Administrators (GBAs) and the Business Support Team as needed.
- Provide expert guidance to authors on how to successfully navigate the archiving process for Non-Clinical and Technical reports in accordance with DRA and FDA regulations.
- Coordinate with authors and the DRA Group to ensure reports are moved through the required stages, including final signing and archiving.
- Act as a liaison between DRA, IDEA for SUB Americas & Germany to assist users with understanding new procedures and accessing training.
- Serve as a liaison for the new BIRDS system, which is replacing IDEA for SUB, ensuring smooth transitions and assisting with user adoption.
Job Description:
Provide comprehensive administrative support to managers, including handling confidential information with discretion and assisting with special projects. Ensure the efficient organization and maintenance of the department’s filing system, including confidential data. Offer clerical support as needed, including filing tasks. Perform additional duties as required.
Responsibilities:
- Serve as the primary contact for training support and troubleshooting for the BIRDS system within the team.
- Keep the team updated on new BIRDS developments, system updates, and relevant information.
- Collaborate with the DRA Manager of the EU Regional Archiving Center to design workarounds and best practices for the archiving process.
- Communicate with other Key Users and LBACs to exchange vital information as the BIRDS system is implemented and refined across the Human Pharma community.
- Escalate unresolved issues to the appropriate Global Business Administrators (GBAs) and the Business Support Team as needed.
- Provide expert guidance to authors on how to successfully navigate the archiving process for Non-Clinical and Technical reports in accordance with DRA and FDA regulations.
- Coordinate with authors and the DRA Group to ensure reports are moved through the required stages, including final signing and archiving.
- Act as a liaison between DRA, IDEA for SUB Americas & Germany to assist users with understanding new procedures and accessing training.
- Serve as a liaison for the new BIRDS system, which is replacing IDEA for SUB, ensuring smooth transitions and assisting with user adoption.