1) Maintain high quality of documents related to clinical development and Postmarketing activities in compliance with related regulations, SOPs and other related procedures 2) Support discussion of study concept, interim/final study report (CSR), the postmarketing data package and PVP strategy proposed by CDD-J and Teams based on latest regulation, internal/external information and CD&A’s direction. 3) Oversee to CDD-J’s trial level activities of clinical development and CDD-J’s supports for program level regulatory documents and safety reporting (e.g., Investigator’s Brochures, briefing books, safety updates, CTD, RE-examination application, the other submission dossiers responses to Health Authorities, Periodic Safety Update Reports, Drug Safety Update Reports and other safety related documents) 4) Gather and input latest clinical trial/PMS/drug development trend/information and enhance innovative approach in the clinical development and post launch area to maximize data utilization and lead the industry. 5) Enhance CDD-J’s skills, maximize their abilities through daily work, role based training, OJT, etc. provide on-boarding, training & mentoring support, and cultivate their talent & career development. 6) Ensure adequate reporting of adverse events/ technical complaints/ compliance issues in accordance with company procedures. 7) Lead or serve on Japan process improvement work streams, act as Subject Matter Expert for SOP or trainings, and/or contribute to cross-functional initiatives 8) 100% timely delivery of all training requirements including compliance 9) Expand our external network to maximize the scientific values gained in the post launch phase.

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Accessibility and Accommodation:

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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