Manager, Regulatory Information Management
il y a 1 semaine
Site Name:
UK - London - Brentford, Belgium-Wavre, Durham Blackwell Street, Poznan, UK - Hertfordshire - Stevenage, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence
Posted Date:
Mar 3 2023
Manager - Regulatory Information Management (RIM) - IDMP
As the IDMP RIM Manager, you will be a critical interface between the IDMP team, RP&S RIM team and enterprise IDMP data owning functions.
You will be responsible for oversight of data lineage, integrity and curation activities, assessment of data flows, identifying potential risks and mitigations strategies, and optimizing business processes in conjunction with Business Process Owners.
The role will support mastering of Product and Substance structured data as close to source as possible by leveraging the regulatory ISO IDMP standards.
This role will help ensure the quality of structured data across systems and alignment of data with Health Authorities.
You will work collaboratively with stakeholders across R&D, GSC and Tech to agree on data governance priorities and look to maximise the business value and build plans to deliver against those priorities.
This role will assist with the assessment of HA data requirements and GRA's ability to fulfil these, as well as data governance, validation, and curation activities.
This role will include participation in both the IDMP implementation team as well as routine engagement with the RP&S RIM team.
- Evaluate the IDMP enterprise framework and implement RIM process revisions to ensure compliant IDMP regulatory submissions, robust data governance, and monitoring data quality
- Assess optimization and automation of any structured data submissions to health authorities to drive resource efficiencies and simplification
- Ensure continued oversight of EU SPOR data in Reg Vault with specific focus on standardized and improved addresses and Organisations (OMS) processes and maintenance of Referential (RMS) lists in conjunction with MDM CoE.
- Engage key enterprise stakeholders to ensure IDMP and other related processes are embedded as BAU for RIM team and wider use across GRA
- Operate as a Regulatory IDMP data owner, collaborating with enterprise business stakeholders to understand customer requests, competitive activities, and industry regulations/trends
- Supporting the use of SPORIFY and related software to facilitate cross functional business processes
- Partnering with Reg Systems & Services to support the continued iteration of the data model within Regulatory Vault. Supporting the movement of data from GSK configuration to Veeva configuration as product matures
- Engaging and supporting the GSK IDMP Program to enable overall business readiness and ensure preparedness for emerging structured data requirements
_ Closing Date for Applications: 17th March 2023 (COB)_
Please take a copy of the Job Description, as this will not be available post closure of the advert.#LI-GSK
_ Why you?_
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree in Life Sciences, or extensive practical experience
- Extensive experience of Pharmaceutical Regulatory Affairs covering a breadth of global regulatory procedures
- Demonstrated ability to work with regulatory product data to drive compliance and business process improvements related to RIM
- Ability to work well both independently and within or leading a team to ensure ontime delivery of objectives/projects
- Demonstrated Project management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers.
- Knowledge of the scaled agile framework and guiding principles
- Experience working within a complex IT system landscape with colleagues from GSK Tech, Quality and Training organisations to deliver GXP compliant systems
- Ability to manage and motivate matrix teams in a globally diverse organisation
Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- Knowledge of ISO IDMP (Identification of Medicinal Products) standards, Master Data Management (MDM) principles, xEVMPD requirements and/or data governance practices
- Knowledge of the use of data in regulatory processes and systems; experience in Regulatory Information Management (RIM) systems such as Veeva Vault
- Agile and/ or Veeva RIM experience is advantageous
- Service/customeroriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
- Has strong sense of urgency, able to effectively prioritize such that key issues or emerging high priority matters are handled in a timely and effective way.
- Ability to define and implement new processes and solutions with an awareness of relevant controls and impacts.
- Demonstrated ability to think flexibly in order to meet constantly shifting priorities and timelines.
- Confidence to challeng
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