Are you passionate about driving innovation at the intersection of business and technology?
Join GSK's Regulatory Operations Function and take the lead in optimizing IT systems and business processes that support our mission to improve lives worldwide!
In this dynamic role, you'll optimize the collaboration between Regulatory business groups and IT teams—both in-house and with vendors—ensuring seamless interaction and the efficient use of cutting-edge technology. Be a part of a forward-thinking team dedicated to advancing regulatory excellence and making an impact on the future of healthcare.
This role serves as the Service Manager and the Business System Owner (BSO) for Smartsheet (including Smartsheet solutions) to support the GRO.
Key Responsibilities (but not limited):
Project Oversight
Lead and coordinate business engagement in projects in collaboration with IT and Business Project Teams to ensure effective solution delivery and ongoing support.
Facilitate workshops with business experts to gather and agree on requirements using strong facilitation and influencing skills.
Define and document user requirements to ensure clarity and alignment with project goal.
Recommend and design process improvements to support system implementation.
Cross-Functional Collaboration
Collaborate with Regulatory Affairs, IT, Quality, and other cross-functional teams to ensure regulatory systems effectively support end-to-end regulatory processes and business objectives.
Own Smartsheet projects backlog and collaborate with Regulatory Platform Innovation team and other key stakeholders in continues improvement of existing systems and solutions and designing and building innovative Smartsheet solutions.
Represent Regulatory Systems in cross Regulatory initiatives taking a lead role to define requirements, identify solutions & drive implementation.
Provide operational support to GRA (Global Regulatory Affairs) for Regulatory Systems.
System Management
Manage, maintain, and optimize key regulatory business systems to ensure they meet operational needs and compliance requirements.
Serve as the System Administrator for Smartsheet, managing licenses and making purchases as required.
Ownership and maintenance of the DTMS documentation for Smartsheet as a platform and TPRM for Smartsheet as a vendor.
Lead support for a varied portfolio of off the shelf and bespoke regulatory systems that are used globally for the delivery and maintenance of regulatory activities.
Innovation and Improvement
Manage and perform User Acceptance Testing (UAT) process within project lifecycle to ensure high-quality system performance.
Utilize extensive knowledge of tools to design user-centric solutions that align with business needs.
Contribute to the development of project proposals and business cases, driving innovation.
Identify process improvement opportunities and collaborate with senior managers to gain approval and implement changes that enhance system performance and user satisfaction.
Compliance and Risk Management
Ensure regulatory systems comply with global regulatory requirements and internal standards and proactively identify and mitigate risks associated with system usage and data management.
Support audits and inspections by demonstrating compliance and providing accurate documentation related to assigned activities.
Leadership
Lead a team including setting goals, providing feedback and conducting performance evaluations.
Oversee workload in area of responsibility.
Serve as point of escalation.
Mentor junior staff within the team on processes and tools.
Basic Qualifications:
A Bachelor’s degree in a relevant field such as Life Sciences, Pharmacy, Regulatory Affairs, Information Technology, or a related discipline is required.
Experience in managing/supporting regulatory business IT systems (including practical experience with business system ownership, business system lifecycle management, change management).
Smartsheet Product Certification or willingness to obtain it within a specified timeframe (e.g., six months).
Knowledge of all Smartsheet premium applications such as Control Centre, Bridge, Dynamic View etc.
Comprehensive understanding of DTMS documentations and Third-Party Risk Management (TPRM) processes, with ownership of creating, maintaining, and updating related documents to ensure compliance, accuracy.
Experience delivering business operational support to critical regulatory systems in a global environment.
Experienced at leading and participating in Business Change Teams delivering IT solutions for the business.
Extensive experience of working within a regulated project delivery environment.
Ability to communicate and provide assistance and support on both sides of the Business-IT interface.
Proven ability at effectively interacting with senior managers within the organization.
Experience in Business Analysis and Business Process Design.
Experience in presenting systems/ processes/documentation during audits and/or inspections.
Proven ability to take an organized and methodical approach to problem solving/trouble shooting.
Preferred Qualifications:
Demonstrated ability to build, mentor, and manage high-performing teams.
Understanding of CFR Part 11, Annex 11, Data Integrity principles, GAMP 5 methodology, CSV, SDLC process.
Software and System Experience (one of more of the following):
Parexel Insight Manager – RIM and Cognos Reporting
Documentum D2 – Labeling System
CSC Regulatory Submission Suite (eCTDXpress, Publisher, Toolbox, Viewer)
Global Submit Validate – Lorenz eValidator
Axway eSubmission Gateway – FDA Web Trader, EMA Gateway CESP
Veeva Regulatory Vault
PowerBi
SharePoint
Professional Certifications (Preferred):
Relevant professional certifications such as Regulatory Affairs Certification (RAC), Project Management Professional (PMP), or certifications in IT systems management (e.g. ITIL4) are advantageous.
What we offer:
Career with purpose - whatever it is you’re doing, you’ll be sharing our mission to improve the quality of human life, by enabling people to do more, feel better and live longer.
Non-wage benefits (medical care, life insurance, pension scheme, sports card, recreation allowance, social fund, preventive healthcare services).
Hybrid working model ( 2/3 days per week in the office).
Career at one of the leading global healthcare companies.
Supportive & friendly working environment.
Corporate culture, based on being Ambitious for patients, Accountable for Impact and Doing the right thing, which powers our purpose, drives delivery of our strategy and helps make GSK a place where people can thrive.
As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at [email protected] to discuss your needs.
#LI-GSK #LI-Hybrid
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. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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