Manager, Expert Scientific Writer
Core
Lead the authoring of clinical and regulatory documents for Phase 2/3 studies and regulatory submissions to the PMDA in Japan.
Role type
Senior IC scientific writer (regulatory/clinical documentation)
Builds
Clinical study reports (CSR), regulatory submission documents (CTD), briefing documents for PMDA consultation, orphan drug designation documents
Domain
Pharmaceutical industry, clinical development, regulatory affairs (Japan/PMDA)
Required skills
Clinical/regulatory document authoring, PMDA review tendencies, J-CDL/J-CS standards, global regulatory strategy alignment, vendor management (CROs/translators), timeline management, complex data analysis, cross-functional communication
Preferred skills
PharmD/PhD/MD, MS/BS in life sciences, experience with pre-JNDA/Eop2 consultation documents, document management systems
Technologies
CROs, translation vendors, document management systems
Responsibilities
Lead authoring of clinical/regulatory documents for Japan, build storyboards for regulatory dossiers, finalize domestic regulatory dossiers, propose optimal strategies for PMDA submissions, manage outsource vendors, review and edit clinical modules, advise other scientific writers, drive process improvements
Seniority
Manager, hands-on IC