As a Non-Clinical expert, you will ensure the high-quality preparation of J-CTD (M.2.4. and 2.6) in collaboration with HQ.
While most modules are Japanese translations of HQ's CTD, you must thoroughly have knowledge on each module's content and verify its accuracy.
Module M2.6.2 is prepared by Novo Nordisk Japan or outsourced based on study reports.Additionally, you'll be tasked with preparing high-quality responses to inquiries from PMDA (Pharmaceuticals and Medical Devices Agency) in partnership with HQ, requiring accurate understanding and communication of inquiries to HQ, though the majority of responses are prepared by them.
Other role expectations include:
To partially prepare or review the PMDA meeting package and reply to inquiries, which are basically created by HQ.
In particular, you will provide comments from scientific and strategic viewpoint to the author.Ensure the provision of translated documents with sufficient quality, such as the PMDA meeting package, CTD, and responses to inquiries from PMDA.
Contribute to global non-clinical activities by supplying HQ with crucial Japanese regulatory information, including details on drugs undergoing development, submission, post-approval, and business phases with similar indications.
Deal with paper-based compliance inspection and raw data check by PMDA including preparation and coordination with HQ. Provide lecture on non-clinical development to staff who do not specialize in non-clinical.Senior Non-clinical expert has a responsibility to coach and educate other Non-clinical expert regarding the general and professional competencies, skills and knowledge in order for them to accomplish their accountabilities.
Qualifications Master's degree or equivalent is required.More than 5 years of experience in the Japanese non-clinical process, from NDA/PMA to approval in drug development, is mandatory.
This includes expertise in non-clinical areas and essential scientific and medical knowledge related to company projects and products.Expertise in one or more of ADME, toxicology, and pharmacology, including safety pharmacology, with knowledge of GLP or relevant guidelines is required.
Experiences in PMDA consultation, CTDs, and replying to inquiries from PMDA are required. Ability to read, write, and speak English. Must also have excellent Japanese writing skills to create documents. Working at Novo Nordisk At Novo Nordisk, we don't wait for change. We drive it.We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.
We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them.From research and development, through to manufacturing, marketing, and sales – we're all working to move the needle on patient care.
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