Haleon
OperationsandSupportSpecialist-Clinical
Neural analysis suggests this role is
optimal for Mid candidates.
“Operations and Support Specialist - Clinical at Haleon. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics. Provide complex query support for business partners. Collect, maintain and prioritize user requirements”
Industry & Context.
troubleshooting; Provide consultation and troubleshooting support for system errors and failures
What They're Looking For.
Must Have
Bachelor's degree in life sciences or information technology or other related area, 5 years pharmaceutical industry and/or consumer goods industry knowledge and experience with minimum 2 years in Regulatory or a related field, Experience in system configuration, preferably Veeva Vault systems, Experience with validated document management systems, Experience with supporting Regulatory, Clinical or PV system configurations and E2B R2/R3 connection and submissions, Proven understanding of the regulatory/pharmacovigilance/clinical research processes and major agency regulations like FDA, EMA, PMDA, MFDS and NMPA, ICH GVP and GxP regarding systems validation and documentation, Track record of success in continuous improvement, innovative work practices and driving change
Nice to Have
Technical background and computer proficiency in a variety of pharmacovigilance, regulatory, clinical or related systems, reporting capabilities and familiarity with MS O365, Excellent interpersonal and written and verbal communications skills with a proven ability to interact well with all levels, Ability to identify opportunities for process and compliance improvements, Enhanced customer service orientation and ability to communicate professionally to diverse cross-functional, non-technical and technical audiences, Experience in work requiring attention to detail and excellent follow-up, Self-motivated, able to resolve issues with cross-functional teams with minimal supervision, Experience of working within Agile delivery methodology with an understanding of the system development life cycle a plus, Knowledge of JIRA backlog and requirement management
What You'll Do.
Provide complex query support for business partners
maintain and prioritize user requirements
Manage System Access Plans and user account oversight
Contribute to Business Continuity planning
Support end users with functionality/capability assistance
Provide processes and solutions that support business processes
Ensure GxP requirements and inspection readiness are maintained
Support Audit/Assessment/Inspection readiness
Create climate for continuous improvement
Optimize processes with appropriate solution
maintenance and execution of user acceptance test scripts
Identify opportunities for testing efficiencies
Provide input for development
implementation and maintenance of written standards
Oversight of applicable vendor/contract staff
Assist in managing projects from initiation through completion
Lead or coordinate project planning
reporting and troubleshooting
Provide input on impact of enhancements and change requests
Resolve and escalate applicable incidents
Contribute to discussions with business stakeholders
Support documentation of internal processes
Support internal and external audits
Support product acquisition and divestment projects
Maintain electronic systems-related portions of PSMF
Provide user guidance and support
Provide consultation and troubleshooting support for system errors
How You'll Work.
Team & Collaboration
Engagement with relevant cross-functional working groups; Management of key stakeholders; Act as a conduit to system end users and Tech colleagues; Working in close collaboration with business owners and stakeholders; Working in close collaboration with Operations and Support colleagues; Contribute to discussions with business stakeholders; Resolve issues with cross-functional teams
Communication Scope
Excellent interpersonal and written and verbal communications skills; Ability to communicate professionally to diverse cross-functional, non-technical and technical audiences
Process & Methodology
project management, Assists in managing projects from initiation through completion, Leads or coordinates project planning, resourcing, reporting and troubleshooting
Full Job Description
Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity. Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science. Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture. **About the role** The Operations and Support Manager Regulatory supports the R&D teams with operational management and use of Haleon’s R&D systems to carry out the business activities of the respective functions. The role requires engagement with relevant cross-functional working groups and management of key stakeholders. The Operations & Support Manager Regulatory is responsible for acting as a conduit to system end users and Tech colleagues to enable development and enhancement of solutions for the assigned business domains. Key activities include project management, data access enablement, metrics, reporting and analysis, dashboard and interface design, process mapping and training support. **Key responsibilities** The Operations & Support Manager Regulatory will be accountable for: * Providing complex query support for business partners * Collecting, maintaining and prioritizing user requirements for applicable applications and solutions * Management of System Access Plans and user account oversight activities * Contribution to Business Continuity planning and execution of BCP activities * S
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