人材紹介Michael Page Japan
|企業名||European Pharmaceutical Company|
メディカル/医薬/バイオ/素材/食品 - 生産技術/生産管理
* Create and review clinical parts of CTD (Module 2.5, Module 2.7 etc) of NDA application materials and clinical trial documents (clinical trial implementation plan, clinical study report etc.), in a high quality and timely manner.
* Author clinical/regulatory documents and support performance goals (including quality and time-line) for filing regulatory dossiers in Japan as planned by the R&D Development Teams.
* Prepares and finalizes clinical and regulatory documents (CSR, CTD for Clinical Parts and HA response document, IB, briefing documents, Manuscript) with quality.
* Establish cooperative partnership with other functions within company to maintain fully integrated and standardised processes and systems.
* Act as 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.
their capabilities in creation of clinical/regulatory documents for Japan.
* Upper business level English, native level Japanese
* Understand the purpose of documents written in English and be able to translate appropriately.
* Medical Writing, Regulatory, or Clinical Development experiences in the pharmaceutical industry, ideally with experiences in approvals.
* Negotiation and coordination skills with CROs on outsourcing of the documentation
* Opportunity to utilise medical writing skills in a cross-functional, multi-lingual environment
Page Group Japan is acting as an Employment Agency in relation to this vacancy.
|* Leading European pharmaceutical company|