Support internal and external customers and promote best documentation practice to ensure efficient an appropriate management of submission-relevant paper and electronic documentation (global/clinical) to meet regulatory requirements for submission to Health Authorities and be inspection ready.

Job Responsibilities:

• May ensure the delivery of CRF/PDR document management services in assigned geographies by collaborating with external partner’s regional coordinators on daily operational activities; monitor/assess appropriate hand-offs by vendors in case of extended support.

• May maintain documentation of appropriate oversight of all external partner’s work specific to document management within CRF/PDR activities

• May develop and recommend risk management, contingency plans and corrective or preventative actions to improve quality and compliance

• May Monitor and assess weekly status reports created by vendor based on Novartis’s input requirements for assigned geographies

• Ensure adherence to standards for the management, archiving, retrieval and technical quality review of documents (global/clinical)

• Define the document management strategy per the CRF/PDR /Regulatory document area of expertise; drive document management delivery of Novartis/ document management standards (global/clinical) and act as first line governance for both internal and external partners

• May assist in driving improvements and innovation on all business and technical aspects of document management and archiving, including implementation of innovative methods

• May act as System Owner/System SME of/for an electronic document management system or business lead of an IT project

• Ensure quality, timelines, and efficiency and high document standards for regional or functional group. Ensure deliverables comply with HA guidelines, Good Clinical Practices and internal SOPs

• Establish and maintain sound working relationships with partners/business functions and customers

• Monitor external partners on a regular basis to ensure high standards of external support.

• May support Document Managers in ensuring appropriate and accurate document creation and document lifecycle management in the Document Management System (DMS).

Requirements:

• College Degree or Equivalent Education in Life Sciences or Related Field or equivalent combination of education, training and experience

• At least 3-4 years of relevant experiences in managing, archiving, retrieving or compiling clinical documents

• At least 3-4 years of relevant clinical research/pharmaceutical industry experiences

• Knowledge of the clinical drug development and international drug approval processes and related document requirements

• Good organizational skills and significant project work or project management experience

• Good IT skills