Manager, Expert Scientific Writer
Core
Lead the authoring of clinical and regulatory documents for Phase 2/3 studies and submissions to the PMDA in Japan.
Role type
Senior IC scientific writer (regulatory/clinical)
Builds
Clinical study reports (CSR), regulatory submission documents (CTD), briefing documents for PMDA consultation, and orphan drug designation materials.
Domain
Pharmaceutical R&D / Regulatory Affairs
Required skills
Clinical study report authoring, regulatory dossier preparation, PMDA review strategy, Japanese and English scientific writing, vendor management, process improvement, cross-functional collaboration
Preferred skills
PharmD/PhD/MD or MS/BS in life sciences, experience with J-CDL/J-CS standards, global drug development knowledge, data analysis
Technologies
Document management systems
Responsibilities
Lead authoring of clinical/regulatory documents for Japan, establish cross-divisional partnerships, set timelines for regulatory dossier completion, propose optimal submission strategies based on PMDA tendencies, complete clinical modules with J-CDL/J-CS, manage outsource vendors, review and edit documents, drive process improvements, advise other scientific writers, facilitate communication between Japan team and HQ.
Seniority
Senior, hands-on IC