Job DescriptionIn order to obtain earliest regulatory approval in Japan, the Clinical Science Group (CS group) will formulate and implement elaborated development strategies and clinical documents based on medical writing skill with the relevant clinical scientific expertise. In particular, Clinical Scientist (CS) is involved in preparation of the clinical part of PMDA meeting package and CTD in collaboration with HQ’s Medical Writers (MWs). Also this position can support post NDA activities and marketing activities if needed.
- PMDA consultation
- NDA document and the replies to PMDA queries:
- Together with HQ-MWs and relevant persons, to have overall responsibility for completing clinical part of CTD (clinical summaries /clinical overview) for Japanese NDA and quality of them including the content and strategy in collaboration with global team.
- To explain Japanese requirements to HQ-MWs in order to have them prepare J-CTD that meets these requirements
- To cooperate with regulatory publisher, who has responsibility for finalising eCTD.
- To prepare or review a draft CTD, responses to inquiries given by PMDA in collaboration with global team
- To give support to a preparation of package Insert (PI), if needed.
- To provide translation of documents with enough or high quality, such as PMDA meeting package, CTD and replies to inquiries given by PMDA. In particular, to submit the translation to PMDA without the supervisor’s review.
Requirements- University degree (a master degree preferable)
- 8 or more years of experience in the development of new drugs
- Clinical and scientific knowledge concerning the areas of medical treatment relevant to the project
- Knowledge concerning relevant regulations and guidelines concerning new drug development, experience in meeting and negotiating with the authorities
- English writing skills enough to create CTDs and replies to inquiries.
- English language ability (all aspects, including conversation, reading, and writing)
- Team development and facilitation ability
- Knowledge of GCP, guideline and other relevant regulations.
- Statistical knowledge to appropriately interpret the study results.
- Basic knowledge of pharmacodynamics/pharmacokinetics to appropriately interpret the study results.
- Enough level of MS-word, Acrobat Professional skill
- Medical writing skills excellent enough to provide lecture in external workshop