Major accountabilities:

• 1. Support the global cross-functional Transparency Submission Team to ensure all Clinical Transparency submission documents are delivered in accordance with timelines, high quality, operational and technical procedures.
• 2. May attend Transparency Submission planning meetings with cross-functional team members to support the definition Transparency submission content.
• 3. May contribute to pre-submission Health Authority Transparency In Scope Document books; applying lessons learned and potential efficiencies used successfully by other Transparency submission teams.
• 4. Attend, as required, Transparency Submission Team meetings, to provide support regarding deliverable timelines; ensure timelines are in accordance with Novartis processes.
• 5. Perform as needed marking and redaction/anonymization of clinical trial documentation using appropriate tools.
• 6. When required transfer the encrypted raw and analysis data via Intralinks or similar secure tool to Vendor and perform Acceptance Testing on all dataset deliverables received from Vendor, migrating completed anonymized datasets to GPS.
• 7. Complete QC on vendor and Novartis deliverables for those projects assigned to.
• 8. Support publishing, posting and archiving of clinical trial documentation and data sets for disclosure.
• 9. Work with Transparency Management to track globally Health Authority requirements specific to the sharing of Clinical Trial data.
• 10. Contribute to continuous improvement of submission processing and knowledge transfer within Development via cross-functional ‘Lessons Learned’ sessions.

Key performance indicators:

• 1. Quality and timely deliverables of shared documents and data sets.
• 2. Demonstration of execution of transparency strategies across sharing initiatives.

Minimum Requirements:
Work Experience:

• 1. 5+ years' experience in the pharmaceutical industry and broad understanding of the drug development process.
• 2. Knowledge of clinical trial transparency or clinical trial data areas.
• 3. Knowledge of the emerging principles/guidelines governing clinical trial transparency, as well as an understanding of the driving forces and their associated perspectives.
• 4. An understanding of the steps, roles and responsibilities in generating clinical trial documentation, data sets, and submissions.
• 5. Innovative critical thinking; detail-oriented yet pragmatic problem-solving skills.
• 6. Understanding of data privacy.
• 7. Good interpersonal and communication skills (verbal and writing) bridging scientific and business needs.
• 8. Experience in process improvement initiatives.