Expert Regulatory Writer

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.
 

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 (key regulatory 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.
 

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.

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