Company OverviewPharmaceuticals Company
Job Description・ A senior level scientific writer who creates basic clinical/regulatory
documents (e.g. CTD M2.7.6), complex clinical/regulatory documents
(e.g. CTD M2.7.3/2.7.4, CSR) and high level clinical/regulatory documents (e.g. CTD M2.5, responses to Health Authority) independently, ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members.
・ Participate in relevant filing subteam(s) and ensure effective planning
and management of timelines for clinical/regulatory documents of assigned projects.
・ Comply with internal and external processes and guidelines while
managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
・ Review and edit other clinical/regulatory documents as required.
Requirements・ PharmD/PhD/MD in a relevant scientific discipline, or MS/BS with a
minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent.
・ Good understanding of global pharmaceutical drug development and
requirements for submission of regulatory dossiers to global health
・ Demonstrated strong writing skills both in Japanese and in English,
preferably in authoring and leading the production of clinical/regulatory documents for submission to PMDA.
・ Ability to analyze and interpret complex data from a broad range of