Pharma Medical Writer Post Vacancy @ Novartis – Apply
Pharma Medical Writer M.Pharma writer. Pharmaceutical Jobs. Applications are invited for the post of expert@ Novartis.Career @ Novartis. Pharma job opportunity at Novartis.vacancy at Novartis. Interested candidates may apply online. Check out all the details on Rasayanika.com
Job Title: Medical Writer
Job Id: 282091BR
Eligibility:
- M.Pharm/M.Sc Good communication skills in english (written, verbal, presentations) 2 to 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.
Your responsibilities include, but are not limited to:
1. To author, review and independently manage high-quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, Informed Consent Form (ICF) as per style guide.
2. To perform Quality Control (QC) of different regulatory documents
3. Liaise with medical/clinical experts, statisticians, investigators
in concept development when protocol is being developed and work in a collaborative fashion for global/CPOs4. 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
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