Senior Medical Writer job @ Novartis
Job Description
1.To author, review and independently manage high quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, Informed Consent Form (ICF).
2.To write CTD modules and other safety documents (DSURs, RMPs) independently
3.Liaise with medical/clinical experts, statisticians, investigators in concept development when protocol is being developed and work in a collaborative fashion for global/CPOs
4.Contribute to planning of data analyses and presentation to be used in CSRs
5.Ensure compliance of documentation to internal company standards and external regulatory guidelines.
6.Act as project medical writer for various programs in CPOs/global organization and ensure medical writing resource allocation to studies within these programs.
7.Supervise outsourcing to external medical writers, if necessary in conjunction with mentoring medical writer.
8.Follow and track clinical trial milestones and resource requirements for assigned projects
9.Training and mentoring of associates as required.
10.Contribute to cross-functional communication to optimize feedback and input towards high quality documents.
11.Maintain audit, SOP and training compliance.
Minimum requirements Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/medicine/pharmacy is desirable.
PhD or degree in medicine (MBBS/MD)
≥ 3 years of regulatory medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus in-depth knowledge of medical writing processes.
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