Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Senior Medical Writer I
• To author, review and independently manage high quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, Informed Consent Form (ICF).
• To write other regulatory documents (DSURs, RMPs, clinical overview, summary of clinical safety and efficacy) with supervision from experienced medical writer initially if required
• 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.
• PhD or degree in medicine (MBBS/MD), or M.Pharm/M.Sc Good communication skills in english (written, verbal, presentations)
• ≥ 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.
• Good operational knowledge of clinical trial reporting. Good knowledge of biostatistics principles. Strong ability to prioritize and manage multiple demands and projects.
• Knowledge of and experience in global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements).
• Good experience in managing global, cross functional teams or simple global projects. Ability to work in teams.
Experience : 3 years
Qualification : M.Sc./M.Pharm
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Research & Development
ID : 282091BR
End Date : 25th December, 2019
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