Senior Specialist - RIM&DO

GSK India

6 - 8 years

11 - 12 Lacs

bengaluru

Posted:1 day ago| Platform:

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Skills Required

procurement supply chain business process data management analytical trend analysis oncology data quality document management information management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Sharing Subject Matter Expertise in Regulatory Information Management Systems and Processes in-use within Global Regulatory Affairs, requiring a deep understanding of the Regulatory Vault data model and legacy RIM systems
Creation and maintece of Regulatory Information within the companys Regulatory Information Management (RIM) system with information provided on demand by end users for all GRA Submission activities typically supporting urgent timebound requests.
Accurate completion of more complex or non-routine data maintece tasks to an agreed schedule
Provision of primary support to end users of RIM systems and processes to enable efficient ways of working including: provide basic guidance, adhoc training, attendance at group meetings, provision of appropriate Reports etc
Monitoring data quality routinely to identify and mitigate issues. Additionally, conducting root cause analysis and trend analysis to identify appropriate corrective/preventative actions
Ensure own work and that of junior colleagues is compliant with data standards and defined procedures
Streamlining regulatory information communication to Manufacturing and/or QA Release stakeholders to facilitate Supply Chain and QA Release operations
Routine/ ad-hoc extraction and transformation of raw data from various Regulatory Information Management (RIM) systems for KPI generation in the context of data quality improvement and performance monitoring
Provision of support for system validation activities such as User Acceptance Testing, with a foundational understanding of the requirements of the Change Control procedures for enabling full impact assessment of any system/process change.
Responsible for establishing maintaining appropriate procedural documentation where needed: SOP, WI, How to Guide, User Manuals and Handbooks
Ensuring continuous improvement (process system) culture within the team for the benefit of GRA. Ensure understanding of upcoming system changes, propose changes and support the implementation of those changes within RIM.
Where applicable, perform the role of RIM Subject Matter Expert, driving a partnership with GRA Process Leads, developing deep understanding of GRA E2E business process, sharing technical expertise to support the business and continuous improvement.
Mentoring and support of new starters or junior colleagues
Ensuring appropriate procedures are followe'd in the maintece of System Reference Data.

Basic qualifications-

A minimum of 6-8 years of experience in data and or records management, handling user requests.
Consistently accurate completion of a significant number of data management tasks including a broad range of procedures.

Related experience -

Good understanding of the role and responsibility of Registration Information Management
Awareness of standard submission formats, with ability to navigate submission content
Awareness of relevant health authority regulations and guidance, technology trends, as we'll as industry standards concerning record keeping practices, document/information management and HA submission requirements.
Knowledge of records retention procedures and relevant regulations and business practices regarding regulatory document management
Analytical capability; ability to work with large and varied datasets
Good interpersonal skills, service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary, global, and matrix environment.
Familiarity with GSK organization and processes associated with gaining and maintaining marketed and investigational product authorizations
Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
Excellent written and verbal communication skills and ability to present information in a clear and concise manner
Demonstrated knowledge of GSK Marketed Products and development products. Awareness of drug development process
Organization, prioritisation and coordination skills
Demonstrated proficiency in use of standard IT tools
Familiarity with GSK IT systems in general and RIM tools, plus awareness of system validation methodology.

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