Job Description

Are you passionate about driving innovation at the intersection of business and technology? Join GSK's Regulatory Operations Function and play a key role in maximizing the value of IT systems and business processes! In this dynamic role, you'll optimize the collaboration between Regulatory business groups and IT teamsxe2x80x94both in-house and with vendorsxe2x80x94ensuring 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 Business System Owner (BSO) for a number of systems in the Labelling Operations space.Key ResponsibilitiesLead and coordinating the business engagement in projects in collaboration with IT and Business Project Teams to coordinate solutions delivery and support.Lead workshops with business experts to agree requirements xe2x80x93 using good facilitation and influencing skillsDefine and document user requirementsRecommend improvements to or new processes to support implementationDesign solutions using knowledge of tools (e.g. Cognos)Apply knowledge data migration processes to ensure a robust solution identifiedManage and perform User Acceptance process within project lifecycleRepresent Regulatory Systems in cross Regulatory initiatives taking lead role to define requirements, identify proposals & lead implementationContributing to development of project proposals and business cases.Identify process improvement opportunities and work with senior managers to gain endorsement to implementLead 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.Provide operational support to GRC for Regulatory SystemsMentor junior staff within the team on processes and toolsBasic QualificationsBachelor degree in scientific or technical area of specializationExperience delivering business operational support to critical regulatory systems in a global environment (Regulatory Information Management and Reporting, Electronic Publishing and Validation Systems, Electronic Data Exchange and/or Labeling Management Systems).Experience at managing/supporting regulatory business IT systems is a must haveExperienced 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 managing change control and system lifecycle within a regulated environment, ideally in drug / vaccines development.Experience in Business Analysis and Business Process Design.Preferred QualificationsExperience with business system ownership and business system lifecycle management.Fluent and able communicator in English and local languageStrong communication and influencing skillsAbility to self-manage the work and prioritize effectivelyService orientation, customer-focusedGood team worker, but with confidence to lead when appropriateGood understanding of IT lifecycle, processes and quality managementSoftware and System Experience (any)o Parexel Insight Manager xe2x80x93 RIM and Cognos Reportingo Documentum D2 xe2x80x93 Labeling Systemo CSC Regulatory Submission Suite (eCTDXpress, Publisher, Toolbox, Viewer)o Global Submit Validate xe2x80x93 Lorenz eValidatoro Axway eSubmission Gateway xe2x80x93 FDA Web Trader, EMA Gateway CESPo Veeva Regulatory Vaulto PowerBi

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This position can also be filled in Mexico City#GSK
#Mississauga#MexicoCityWhy GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose xe2x80x93 to unite science, technology and talent to get ahead of disease together xe2x80x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns xe2x80x93 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, itxe2x80x99s 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 xe2x80x93 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 . Please do not send resumes to this e-mail and instead apply through the online application process of this posting.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

GlaxoSmithKline