Medical Writer

240096BR
Medical Writer
You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV.
Job Purpose :
To write, review and manage the preparation of high quality clinical documents for CPO’s and global organization. To provide authoritative documentation related consultancy to other line functions.

Major Accountabilities :
• To author, review and independently manage high quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, Informed Consent Document (ICD), and other regulatory medical writing documents
• Liaise with medical/clinical experts, statisticians, investigators in concept development when protocol is being developed and work in a collaborative fashion for global/CPOs
• Contribute to planning of data analyses and presentation to be used in CSRs
• Ensure compliance of documentation to internal company standards and external regulatory guidelines.
• Contribute to cross functional communication to optimize feedback and input towards high quality documents.
• Maintain audit, SOP and training compliance.

• Minimum a Life Science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/medicine/pharmacy is desirable
• Fluent in English and Japanese (oral and written) is a must.
NBS
PLS NBS
Malaysia
Petaling Jaya
Malaysia Novartis Corporation (Malaysia) Sdn. Bhd., Kuala Lumpur
Research & Development
Full Time
Regular