Prepare high-quality and accurate NDA-related documents (CSR, CTD, etc.) in accordance with regulatory requirements based on policies of global R&D and Japan Development.
Formulate strategies such as policy, schedule, budget, etc. for preparation of NDA-related documents as a lead-writer of the project in charge.
Prepare NDA-related documents and arrange their quality control as a lead-writer.
Make every effort to prepare high-quality NDA-related documents in accordance with pharmaceutical regulations, SOPs, manuals, etc.
Contribute to the decision making of the assigned JPT on behalf of Medical Writing Group.
Contribute to the assigned JPT by the support of developing regulatory documents, such as answers to regulatory queries and briefing books.
Formulate strategies such as policy, schedule, budget, etc. for preparation of NDA-related documents of the project in charge and propose them to JPT.
Prepare appropriate procedures for development and maintenance of NDA-related documents.
Build cooperative relationships with stakeholders in Global MW.
Prepare/update appropriate procedures for the vendor management.
Conduct liaison activities with the vendor regarding preparation of NDA-related documents.
Support to develop other medical writers who they cooperate with, with the support of the supervisors if necessary.
Qualifications
Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or other related academic area or equivalent ability is required. Master’s or doctor’s degree is preferred.
TOEIC 700 or more or equivalent English communication skill are required.
At least 5 years’ experience in or equivalent skill for clinical development, regulatory affairs, post-marketing surveillance including any medical writing experience.
Experience of attending the medical writing training course hosted by an organization (e.g., Union of Japanese Scientists and Engineers,
