Document Quality Manager

2 weeks ago

Hyderabad, Telangana, India Novartis Full time

Perform assessment, quality control and publishing of NIBR scientific documents to ensure consistency and to achieve the technical quality to comply with internal and external guidelines.

Oversee external service providers as related to areas of responsibility. Collaborate to support timely compilation of high-quality submissions for Global Health Authorities.

  • Perform technical (Novstyle) quality control (QC) of NIBR submission documents (simple to medium complexity) to ensure both content and format fulfil requirements. Collaborate with globally located NIBR scientific personnel to ensure finalization of the documents, according to timelines and quality requirements.
  • May compile, integrate and publish applicable NIBR documents with state-of-the-art word processing, electronic publishing and document management systems in collaboration with the responsible author(s).
  • Provide advice on template requirements of NIBR submission documents, to effectively guide the authors on document content. Work with external consultants (vendors) to coordinate outsourced activities related to the processed tasks.
  • Manage the NIBR TM preparation activities in support of the NDA annual reports to the FDA, ensuring timely delivery in compliance with the internal SOP and health authority requirements.
  • Resolve technical document or workflow issues as applicable on the documents being processed. Maintain support of IT systems/trackers (e.g., Trackwise, Sharepoint) to ensure accuracy of information by liaising with stakeholders.
  • Advise authors, newcomers and vendors on requirements, technical formatting processes and the use of Novartis' document management systems.
  • Generate ideas on areas for optimization and innovation and assist in process improvement activities related to document quality management and submission management in NIBR.
  • Remain abreast of current processes, regulatory guidelines and legal requirements, as relevant.
  • Assist in the testing for implementation, enhancement and maintenance of regulatory document systems.
  • Provide input as required to content on S&D intranet sites and training materials. Represent S&D on local and/or global teams to provide technical, document or workflow-related expertise as required. Collaborate to provide metrics, KQIs and KPIs.

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