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Job Description Position Title : Run Specialist - Operations Clinical, regulatory & R&D Applications Function : GIDC Location : GC Bangalore About Viatris VIATRIS, is a new kind of healthcare Company, committed to providing access to medicines, advancing sustainable operations developing innovative solutions, and leveraging our collective expertise to improve patient outcomes. Formed in 2020, through the combination of Mylan and Up-John-Pfizer, Viatris bring together best in class scientific, Manufacturing and distribution expertise with proven regulatory, Medical and commercial capabilities to deliver quality medicines to patients when and where they need it. - Fast Facts
Headquartered in the US with global centers in Pittsburgh (USA), Hyderabad (India) and Shanghai (China) Our global workforce of ~45000, includes expertise across scientific, manufacturing, regulatory and Commercial Operations Have ~ 50 Manufacturing Facilities across Oral Solid Doses, Injectables, Complex dosage forms and APIs Total 1400+ Molecules, have portfolio that treats nine out of ten WHO causes of death. Our 200+ medicines are on WHO essential medicines List We have commercial reach to 165+ Countries and territories - Role Purpose
We are seeking an experienced and highly motivated Run specialist to manage and oversee the operational support, governance, and lifecycle management of a portfolio of critical Operations, Clinical, Regulatory, and R&D applications. This includes applications such as Qlik Sense (MMAps, RBQM), R/Posit, Pinnacle 21, Ryze (Formedix MDR), Phoenix (PK-PDModeling), Marvin, Almac IRT, eLAS, eSOCDAT, and DCT (Data Capture Tool). The ideal candidate will have 10+ years of IT experience, proven application support leadership, and a strong understandingof GxP-compliantenvironments and pharma R&D operations. - Key Responsibilities
Application Operations & Leadership Own day-to-day run operations and ensure high availability, performance, and compliance of all supported applications. Coordinate and lead L1.5/L2/L3 support teams for incident management, request fulfillment, and problem resolution. Act as primary point of escalation for application issues and outages, ensuring timely communication and resolution. Application Oversight BCE/Fileshare: Manage file access, data transfers, and secure collaboration with audit trails. Qlik Sense (MMAps, RBQM): Oversee dashboard delivery, data integrity, access, and performance optimization. R/Posit: Support RStudio server environments, user provisioning, and package/version control. Pinnacle 21 & Ryze (Formedix MDR): Ensure metadata and SDTM compliance, validation support, and standards alignment. Phoenix: Administer and support PK/PD modeling software, manage licenses, and troubleshoot modeling workflows. Planisware: Govern portfolio management application for project planning, execution, and reporting. SOS AMI Websites: Ensure availability and usability of site and patient-facing web platforms. Marvin (EDC): Coordinate EDC support, mid-study changes, and eCRF integrity. Almac IRT: Manage user access, change control, and integration support for randomization/supply management. eLAS: Support lab accessioning system usage and role management. eSOCDAT: Administer eSource/eClinical capture and ensure compliance with GxP standards. DCT: Oversee decentralized data capture tool operations, access, device connectivity, and user training. - Governance & Compliance
Ensure all applications comply with GxP, 21 CFR Part 11, GDPR, and internal regulatory policies. Maintain audit readiness and support regulatory inspections by providing complete documentation and evidence. Manage change and release processes in line with validated environments and documentation control. - Continuous Improvement & Reporting
Analyze trends from incidents/problems to drive root cause elimination and service improvement plans. Provide performance and compliance reporting to leadership, including SLA/KPI dashboards. Identify automation opportunities and drive process efficiencies across support functions. - Stakeholder & Vendor Management
Serve as the liaison between business stakeholders, QA, vendors, and platform SMEs. Manage vendor escalations, contract adherence, and performance evaluations. Facilitate service review meetings and application health assessments with business partners. - Experience
Minimum of 10 years of IT experience, with at least 4 years in a Run/Operations Lead role. Proven experience supporting applications in clinical research, biometrics, pharmacometrics, or R&D domains. Deep understanding of GxP, CSV, ITIL frameworks, and validated system operations. Technical & Functional Skills: - Working knowledge of multiple tools from the following categories:
Data Analytics: Qlik Sense, R/Posit Clinical Systems: Marvin, Almac IRT, eSOCDAT, DCT, eLAS Modeling & Standards: Phoenix, Pinnacle 21, Ryze/Formedix File & Project Management: BCE/Fileshare, Planisware, SOS AMI Websites Familiarity with data standards (e.g., CDISC SDTM, ADaM), trial conduct workflows, and integration points. Experience using ticketing and service management platforms like ServiceNow or Jira. - Soft Skills:
Strong leadership, stakeholder communication, and decision-making skills. Ability to work in a fast-paced, highly regulated environment with cross-functional teams. Excellent documentation, reporting, and incident management abilities. Strategic mindset with an eye for operational risk, audit gaps, and proactive improvements.
Preferred Certifications (Nice to Have):
ITIL v4 Foundation or Intermediate GAMP5 / Computer System Validation (CSV) Project Management (PMP/Agile/SAFe) Tool-specific certifications (Qlik, RStudio, Phoenix, Almac IRT, etc.).
