(Novartis) Senior Regulatory Writer
- Tokyo, Japan
9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.
1. To author, review and manage high quality clinical documents and safety documents: complex Clinical Study Reports (CSR), submission documents [clinical portions of the Common Technical Document (CTD) ，J-Risk Management Plan], other documents for health authorities [e.g., Briefing Books (BB), answers to questions].
2. Extended member of Japan Project Team (JPT) and Integrated Clinical Trial Team (iCTT). Core member of Japan Submission Team (JST).
3. Major contributor to planning of data analyses and presentation used in CSRs and submission documents.
4. 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.
5. 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.
6. Contribute to process improvement in RWS and/or cross-functional initiatives or activities.
7. Coach and/or mentor less experienced writers.
8. Leader in cross-functional communication to optimize feedback and input towards high quality documents.
9. Maintain audit, SOP and training compliance.
10. Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
11. 100% timely delivery of all training requirements including compliance.
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Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
Fluent Japanese/English (oral and written).
Experience / Professional Requirement:
• ≥ 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.
• Excellent communication skills (written, verbal, presentations)
• Advanced knowledge of biostatistics principles.
• Strong ability to prioritize and manage multiple demands and projects.
• Ability to define and solve complex problems ("Problem-solver")
• Broad knowledge and future oriented perspective.
• Ability to drive and manage organizational and team performance across cultures.
• Proven track record in matrix environment.
• Some experience in managing global, cross-functional teams or simple global projects.
• Ability to motivate and coach people.
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