メディカル・バイオ - 臨床開発メディカルライター

Major Accountabilities
1. To author, review and/or independently manage multiple concurrent high quality clinical and safety documents complex Clinical Study Reports (CSR), complex submission documents [clinical portions of the Common Technical Document (CTD)]), other documents for health authorities (e.g., Briefing Books,answers to questions, PMS and re-examination related documents).
2. Extended member of Japan Project Team (JPT) and extended member of Integrated Clinical Trial Team (iCTT). Core member of Japan Submission Team (JST).
3. Strategic input into planning of data analyses and presentation (statistical analysis plan review and meetings) used in CSRs, submission documents and/or answers to questions.
4. Documentation expert in JPTs and JSTs to ensure compliance of documentation to internal company standards and external regulatory guidelines. Provide authoritative content and strategic expertise for clinical portions of the CTD.
5. Lead Writer for large and/or complex programs ensuring no submission-critical issues including consistency between documents for assigned programs.
6. Lead Writer for complex submissions, actively contributing to key messaging and pooling strategy, providing expert content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
7. Lead process improvement in RWS and cross-functional initiatives and/or activities.
8. Identify training needs to foster high level of performance within RWS. Coach/mentor and/or train less experienced writers.
9. Leader in cross-functional communication to optimize feedback and input towards high quality documents.
10. Maintain audit, SOP and training compliance.
11. Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
12. 100% timely delivery of all training requirements including compliance.

■休日：完全週休二日制

■Education:(minimum/desirable)
Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.

■Languages:
Fluent Japanese and English (oral and written).

■Experience / Professional Requirement:
• ≥ 8 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus expert knowledge of medical writing processes.
• Expert knowledge of and repeat experience in local regulatory environment and process (keyregulatory bodies, key documents, approval processes).
• Expert knowledge and extensive experience, and demonstrated record of accomplishment in Japan local registering of drugs.
• Advanced knowledge and some experiences of accomplishment in global registering of drugs.
• Excellent communication skills (written, verbal, presentations).
• Expert knowledge of biostatistics principles.
• Proven ability to prioritize and manage multiple demands and projects.
• Demonstrated ability to define and solve complex problems (“Problem-solver”).
• Broad knowledge and future oriented perspective.
• Proven ability to drive and manage organizational and team performance across cultures.
• Proven track record in matrix environment.
• Experience in contributing to global, cross-functional teams or complex global projects.
• Demonstrated ability to motivate and coach people.

■職種未経験者：不可