Novartis Pharma Document Processing Lead Job Opening, Apply Online
Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability build) across Novartis globally. In addition, CDGM is driving the transformation of TMF at Novartis, through the introduction and adoption of new technologies, processes and ways of working.
The Document Processing Team Lead is accountable for the effective planning, delivery and oversight of high quality and timely clinical document processing services (document import, indexing and technical QC) to help ensure consistent, timely and accurate TMF
TMF Document Processing Oversight Team Lead
Job ID: 390601BR
Location – Hyderabad(India)/UK/Ireland
- Deliver excellence in document process service delivery, including optimization and simplification in compliance with Novartis policies & regulatory requirements, responding in an agile way to new or evolving business priorities.
- Provide robust oversight of 3rd party vendor activities related to document processing including monitoring sustainable performance against SLAs.
- Lead or contribute to cross functional initiatives or projects, including defining and gaining approval for projects or initiatives, and ensuring deliverables are achieved in line with agreed timeframes and budget.
- Embed a risk-based mindset across the document processing team ensuring identification, evaluation and management of risks, including mitigation activities.
- Set priorities, manage schedule and develop robust resourcing model to support timely delivery of TMF services.
- Support CDGM and business teams in preparation for and during audits, inspections and migration activities. Own CAPAs arising from inspections/audits ensuring they are closed out on time.
- Lead team, recruit, retain, manage and develop associates through coaching and feedback, talent reviews and other available Novartis resources and tools, and foster a safe environment for team dialogue and growth.
- Advanced degree or combination of Bachelor’s degree in life-sciences/healthcare/pharmacy and relevant industry experience.
- Minimum of 8 years of working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organisations) with specific experience in clinical documentation and/or records & information management.
- Minimum of 3 years’ experience in direct people management or matrix management of project/clinical teams.
- Deep understanding of drug development process, international drug approval procedures and standards (e.g., ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management (e.g., DIA TMF reference model).
- Demonstrated success in planning and executing cross functional projects.
- Strong influencing and presentation skills. Ability to communicate effectively at all levels.
- Good organizational awareness, including experience working in multi-disciplinary teams, across cultures and geographies.
- Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external stakeholders.
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