Site Name: Mississauga Milverton Drive
Posted Date: Dec 18 2024
Job Purpose
As a RIM Expert you will ensure data quality and consistent, effective use of Regulatory Information Management (RIM) systems as well as support GSK’s Regulatory and Pharmacovigilance obligations, GMP-compliant product supply, and business efficiency across the Regulatory Function. Collaboration with end users, process leads, and stakeholders to develop strategies for data entry and drive process and data entry efficiency. We look forward to you shaping the future of our regulatory processes and make a significant impact today!
Details (Your Responsibilities)
Why you?
- Sharing Subject Matter Expertise in Regulatory Information Management Systems and Processes in-use within Global Regulatory Affairs and other stakeholders, requiring a deep understanding of the Regulatory Vault data model and legacy RIM systems
- Monitor ongoing user requests and system activity to identify and act upon potential quality issues or process improvement opportunities, leading small teams when required to deliver efficiency and optimization to the RIM organization.
- Support the Regulatory Information Management & Data Office in analyzing and resolving user requests and issues.
- Providing peer review and quality check support as requested.
- Ensure appropriate communication across the user community to support best practice and consistent system use
- Complete time-critical operational tasks when appropriate (including Business Development and Legal requests)
- Define, implement and oversee data quality monitoring procedures including regular data entry checks and the identification, investigation and remediation of quality issues
- Define system procedures, including reports, to support Business Processes effectively (including KPI and performance metrics) and manage change control procedures to ensure full impact assessment and robust implementation of change.
- Develop, maintain and deliver training and support material, including Written Standards, to ensure appropriate and consistent use of Regulatory Information Management systems.
- Support assessments, audits and inspections with the provision of reports, systems expertise and advice on findings and recommendations
- Lead initiatives and projects to identify, recommend and adopt best practice for a global regulatory approach to document management and other Regulatory Information Management (RIM) Systems initiatives, for example, requirements definition, migration definition & implementation and user acceptance testing 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
Basic Qualifications:
- Bachelor’s degree in a scientific or technical field
- Experience within a regulated or quality-critical environment (e.g. Pharmaceutical Industry Regulatory) with experience in project management
- Has experience of Pharmaceutical Regulatory Affairs covering a breadth of global regulatory procedures
- Has worked with some independence in Regulatory Information management in a multinational environment
- Has worked with a complex IT system within a Regulated environment
Preferred Qualifications:
- Project management skills, overseeing and prioritizing multiple activities
- Good analytical skills and process thinking
- Good team player within multi-cultural environment
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Attention to detail, excellent organization and time management skills
Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
*This is a job description to aide in the job posting, but does not include all job evaluation details.
#LI-GSK
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
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