※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
- Localising and revising global documents and CTDs
- New input/ need to write in Japan, not just localisnig and translating
- Documentation customization
- PMDA submission support
- Wide range of therapeutic area
- Need reading and writing English for Senior Manager, need speaking and listening English for Associate Director to join global conferences
This position is accountable for the timely preparation of high quality, regulatory-compliant clinical document deliverables for company. This position will support the medical writing (WM) activities for one or more clinical programs. This position will function with moderate supervision.
The scope of this position includes the writing, document management, and development support for clinical studyrelated documentation including, but not limited to, clinical study protocols, Investigator's Brochures, and clinical study reports; and to collaborate with cross-functional teams to write and development other CTN or regulatory submission documents.
- Authors or provides authoring support for clinical documents and other assigned tasks within established timelines, with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Clinical document types include clinical study protocols, clinical study reports, Investigator's Brochures and updates, and other regulatory submission documents
- Supports development and implementation of strategy for writing and completion of high quality clinical documents
- Manages the writing and completion of documents and other assigned tasks within established timelines and with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
- Actively supports clinical project team(s), alone or in collaboration with other MWs, and takes responsibility for timely and accurate MW deliverables, negotiating timelines as necessary.
- Participates with other MW team members to develop and support process and standards to be implemented, and takes responsibility for execution across cross functional teams.
- Maintains adherence to uniform processes and standards in partnership with statistical, clinical, regulatory, and pharmacovigilance colleagues.
- Develops effective collaborations with other functional lines in company.
- Ensures consistent support and implementation of MW standards.
- Reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensures adherence to standards.
- Ensures that all activities are conducted in compliance with relevant regulatory requirements.
- 3-5 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge.
※Experiences and skills will be considered
Writing test: 45mins to read sample (about 3pages) and revise
1st: Hiring manager + HR
2nd: R&D VP + HR VP
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.