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Senior Medical Writer 1
5-6 years
Hyderabad / Secunderabad
1 vacancy
Senior Medical Writer 1
Novartis
posted 3hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Location - Hyderabad #LI Hybrid
- To author, review and independently manage high quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, Informed Consent Form (ICF).
- To write CTD modules and other safety documents (DSURs, RMPs) independently
- 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.
- Supervise outsourcing to external medical writers, if required.
- Training and mentoring of associates as required.
- Contribute to cross-functional communication to optimize feedback and input towards high quality documents. Maintain audit, SOP and training compliance.
- Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/medicine/pharmacy is desirable.
- 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 communication skills (written, verbal, presentations)
- 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.
Desirable Requirements:
- Demonstrated ability to establish effective working relationship in a matrix and multicultural environment.
- Demonstrated presentation and diplomacy skills.
- Strong customer-oriented mindset.
Employment Type: Full Time, Permanent
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Rating based on 3 Senior Medical Writer
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Anonymous · Research & Development
in Hyderabad / Secunderabad
Work life balance and flexibility
- Salary - Excellent
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Senior Medical Writer salary at Novartis
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