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
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 other regulatory documents (DSURs, RMPs, clinical overview, summary of clinical safety and efficacy) with supervision from experienced medical writer initially if required
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. Contribute to cross-functional communication to optimize feedback and input towards high quality documents.
7. 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 : Ph.D, M.Sc./M.Pharm
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Research & Development
ID : 278390BR
End Date : 25th October, 2019
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