Senior Medical Writer I @ 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 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.
Minimum
requirements
•
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.
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