• To write and/or edit with guidance of senior writer high quality clinical and safety documents: simple Clinical Study Reports (CSR), submission documents [clinical portions of the Common Technical Document (CTD)], and other documents for health authorities [e.g., Briefing Books (BB), answers to questions, PMS and re-examination related documents].
• Extended member of Japan Project Team (JPT) and extended member of Integrated Clinical Trial Team (iCTT). Core member of Japan Submission Team (JST).
• Participate in planning of data analyses and presentation used in CSRs, summary documents and other relevant documents.
• Act as documentation consultant in CTTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
• Act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
• Support the development of RWS through participating in RWS initiatives and other related activities.
• Contribute to development of processes within RWS and cross-functional initiatives.
• Maintain audit, SOP and training compliance.
• Ensure adequate reporting of adverse events/ technical complaint/ compliance issue in accordance with company procedures.
• 100% timely delivery of all training requirements including compliance.

Education:

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:

• Some medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge.
• Knowledge of regulatory environment and process (key regulatory bodies, key documents, approval processes).
• Knowledge and experience, and demonstrated record of accomplishment in Japan local registering of drugs.
• Excellent communication skills (written, verbal, presentations)
• Knowledge of biostatistics principles.
• Ability to prioritize and manage multiple demands andprojects.
• Ability to define and solve problems ("Problem-solver")
• Knowledge and future oriented perspective
• Understanding of matrix environment
• Global, cross-cultural perspective and customer orientation.

Why consider Novartis?

817million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています。

約10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。

ノバルティスファーマ株式会社は、スイス・バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー、ノバルティスの日本法人です。ノバルティスは、より充実したすこやかな毎日のために、これからの医薬品と医療の未来を描いています。詳細はホームページをご覧ください。http://www.novartis.co.jp

Japan

Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to midcareer.japan@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

ノバルティスは障害を持つ個人と協力し、合理的配慮を提供することをお約束します。

健康状態や障害を理由に採用プロセスのいかなる部分においても、あるいは職務の必須事項を果たすために合理的配慮が必要な場合は midcareer-r.japan@novartis.com宛てに電子メールをお送りください。その際ご依頼内容、ご連絡先、求人票の番号を明記してください。