22 Oct
Sunrise Systems
Tumakuru
12 month contract
Work hours - 04.30 pm to 08.30 PM IST (4 Hours - Part Time)
Qualifications:
- A Bachelor's degree in Sciences, Engineering, or equivalent technical degree.
- Strong IT literacy, aptitude for systems thinking, and demonstrated proficiency working within a regulatory, technical, and/or quality database.
- Proven ability to communicate in written and spoken English.
- Excel including the creation and use of basic data validation functions.
- Organized and self-motivated; able to balance many topics at once and to achieve milestones on time with minimal oversight.
Preferred Qualifications:
- Strong analytical skills including interpretation of data, data completeness, and data quality.
- Experience in an organization with Regulatory Affairs as a compliance function. Experience with company controls for launch clearance and associated data.
- Able to present and articulate progress against project plans at and engage at varying levels of a project team and key stakeholders.
- Able to develop work instructions and other process documentation to support training and development needs.
- Ability to anticipate and meet deadlines, handling multiple simultaneous deadlines, prioritizing work, strong attention to detail, and the ability to retain confidential information.
- Collaborative, responsive, action-oriented, and innovative problem solver.
Summary of position:
- The Regulatory & Technical Data Migration Specialist supports Global Regulatory Affairs through the migration of Regulatory &Technical; Data from EtQ L&R; to EtQ RIMS, as part of the Regulatory Affairs RIMS implementation project.
- The successful candidate will possess the ability to evaluate and collaborate to determine the best path to migrate Regulatory & Technical Documentation from one system to the other.
- The incumbent reports to the Global Regulatory Operations Sr. Manager. The Regulatory & Technical Data Migration Specialist will select, prepare, extract, and transform existing Regulatory & Technical data to support the future state documentation structures in scope of the RIMS project. Primary scope includes RNC Documents, Regulatory Summaries, Regulatory Records, Product SKU Creation in EtQ and Product RNC Database.
Key Responsibilities:
- Partner with EtQ L&R; Documentation owners, Global Regulatory Operations team,
and RIMS project team to ensure in-scope data is appropriately organized in preparation for migration activities and execute in-scope data remediation efforts to close record gaps prior to data migration.
- Develop executional plans, milestones, and progress reports to communicate status of data remediation and organization efforts.
- Participate in business process data migration definition meetings and system interface templates with Process Lead as required to support data extraction.
- Prepare and deliver data transfer templates in partnership with the Digital Technology Solutions Team according to project milestones.
- Work with cross functional and intradepartmental stakeholders to develop and execute data migration activities for in-scope documentation.
- Support the development of data validation planning.
- Execute data validation plans post migration in the EtQ Reliance system and communicate data errors to the Digital Technology Solutions and programming teams per defined escalations procedures.
- Support the development of standardized documentation for record creation in the EtQ RIMS system as requested by RIMS project team members.
General Expectations and Accountabilities:
- Builds capability in self by maintaining and demonstrating a high degree of knowledge and skill in data management, as well as IT literacy.
- Builds and maintains strong relationships and networks with key stakeholders and peers within the RIMS project team and Global Regulatory Affairs team.
- Establishes and maintains collaborative relationships while driving activities to meet business needs.
Develops and maintains a strong spirit of partnership.
- Conduct all communications and transactions with the utmost integrity, consistent with the Client Code of Conduct. Communicate effectively with Regulatory Affairs and QRC Leadership, R&D; Organization, Peers, and Functional Partners. Manage self in accordance with the expected Client Compass Behaviors.
- Experience working with blended teams consisting of employees, suppliers, and consultants with both onshore and offshore resources.
- Excellent written and verbal communication skills along with strong desire to work in cross functional teams.
- Possess strong leadership skills and exhibit creative thinking to be able to come up with inventive solutions to solve business challenges.
- Ability to work in a virtual team which may work across distance (remote), cultures and time zones, in a matrix organization with multiple reporting lines, and may extend outside the Client organization including suppliers, partners and customers.
▶️ Data Migration Specialist II
🖊️ Sunrise Systems
📍 Tumakuru