Non-Clinical Expert

7日前

Chiyoda Novo Nordisk A/S

Do you have a strong background in non-clinical activities? We are looking for a Non-Clinical Expert to join our team at Novo Nordisk. If you are ready to contribute to the development, submission, and approval of new drugs/devices, and have a passion for maintaining existing products, then read on and apply today for a life-changing career

About the department
Novo Nordisk is a global healthcare company with more than 100 years of innovation and supervision in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat serious chronic diseases.
Non-clinical Expert works within the Clinical Department but will be in charge of non-clinical activities on development, submission and approval of new drugs/devices, and maintenance of existing products through generation of documentation with sufficient quality aligned with local non-clinical requirements and other external and internal guidelines.

The position
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.

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