+ Prepare and finalize non-clinical pharmacology documents for PMDA submission. Be representative for key interactions with PMDA in terms of non-clinical pharmacology, aiming for commercial success of Boehringer's products + Make value propositions for all New Molecular Entities (NMEs) in the Japanese market from a biopharmaceutical perspective
**Accountabilities - Related Performance Indicators:**
Understand Global Master Dossier for each NME and prepare its Japanese version of non-clinical section to fit the local requirement, and to address unmet medical needs clearly
・Development of strategic plan for Japanese version preperation to differentiate the product (e.g. additional data, wordings, etc) ・Implementation documentation/review process with well alignment with overall J-NDA submission timeline ・Finalize non-clinical pharmacology section for each submission in timely manner