Summary
To manage business and operational activities of local regulatory writing (RW) to ensure timely production of high quality clinical documentation.
To ensure compliance with global RW strategy and implementation of technical activities & strategies according to internal and external guidelines and business objectives.
To coach, mentor and train less experienced writers.
About the Role
Major Accountabilities
- Business and operational management of local RW.
- Manage quality, timeliness, efficiency and high scientific standards for written documents produced by the local RW; Clinical Study Reports (CSR), Common Technical Document submission documents (clinical overviews, summaries of clinical efficacy and safety), other documents for health authorities (e.g., Briefing Books, answers to questions, PMS and re-examination related documents).
- Act as documentation consultant to other line functions in GDD-J and more widely.
- Lead development of document templates, documentation-related processes and strategies by close interaction with global counterpart.
- Participate in priority setting, workload distribution and resource planning to ensure adequate assignment of writing resource to projects.
- Coordinate outsourcing of RMW activities by acting as liaison between internal vendor management and internal customers
- Contribute to the development of the RW organization through interactions within management team and across functional areas.
- Recruit talent, manage performance (set objectives, review performance and plan compensation).
- Identify training needs to foster high level of performance within RWS. Coach/mentor and/or train less experienced writers.
- 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.
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Key Performance Indicators
- Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards, according to RWS metrics.
- Completion of an adequate volume of work (taking into account complexity) per year in accordance with the Key Performance Indicators.
Job Dimensions
Number of associates:
- Can act as operational and functional manager (head) for Regulatory Writing
- Indirect: matrix management of cross-functional teams.
Financial responsibility:
- Internal costs in RW and external costs for project related activities in documentation area
Impact on the organization:
- Timely preparation of high quality clinical documents supporting pharma/oncology registrations.
- Contributor to cross-functional process improvement.
Ideal Background
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:
- ≥ 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 global regulatory environment and process (key regulatory bodies, key documents, approval processes).
- Expert knowledge, extensive experience, and demonstrated record of accomplishment in Japan local 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
- Repeat experience in managing global, cross-functional teams or complex Japan projects.
- Demonstrated ability to motivate and coach people.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
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 diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.
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
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。
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Development
Business Unit
Innovative Medicines
Location
Japan
Site
Head Office (Japan) (Pharmaceuticals)
Company / Legal Entity
JP05 (FCRS = JP005) Novartis Pharma K.K.
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No