Company OverviewGlobal Pharmaceutical Company
Job Description1. To author, review and manage high quality clinical documents and safety documents: complex Clinical Study Reports (CSR), submission documents.
2. Major contributor to planning of data analyses and presentation used in CSRs and submission documents.
3. Documentation specialist in iCTTs and JSTs to ensure compliance of documentation to internal company standards and external regulatory guidelines. Provide content expertise and guidance for clinical portions of the CTD.
4. Lead Writer for submissions, contributing to key messaging and pooling strategy, providing content guidance, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
Requirements• ≥ 4 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus in-depth knowledge of medical writing processes.
• Advanced knowledge of global regulatory environment and process (key regulatory bodies, key documents, approval processes).
• Advanced knowledge and experience, and demonstrated record of accomplishment in Japan local registering of drugs.
• Advanced knowledge of biostatistics principles.
• Strong ability to prioritize and manage multiple demands and projects.