Senior Regulatory Writer

Job Description

承認申請チームや臨床試験チームのコアメンバーとして戦略を検討し,CTD,CSR,対面相談助言資料,照会事項回答といった規制当局に提出する文書の作成をリードするポジションとなります.ノバルティスでは,今後も複数のプロジェクトの承認申請•取得を予定しており,メディカルライターに対するチームからの期待は大きく,やりがいのある業務です.

患者さんにできるだけ早く薬を届けるために,文書作成のエキスパートしてノバルティスで一緒に働きませんか?

Job Purpose:
To write, review and/or manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide documentation related consultancy to other line functions. To coach/mentor and/or train less experienced writers.

Major Activities:
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.

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. https://www.novartis.co.jp

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

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)
• 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.