【800～1250万円】Senior Regulatory Writer

【求人No NJB2290704】
Major Accountabilities
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）] other documents for health authorities [e.g. Briefing Books （BB） answers to questions PMS and re examination related documents].
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.

■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/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）