Medical
Writer II @ NOVARTIS M.Pharm/M.Sc Good communication skills in english (written, verbal, presentations)
Minimum
requirements
•
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.
Why
consider Novartis?
750
million. That’s how many lives our products touch. And while we’re proud of
that fact, in this world of digital and technological transformation, we must
also ask ourselves this: how can we continue to improve and extend even more
people’s lives?
We
believe the answers are found when curious, courageous and collaborative people
like you are brought together in an inspiring environment. Where you’re given
opportunities to explore the power of digital and data. Where you’re empowered
to risk failure by taking smart risks, and where you’re surrounded by people
who share your determination to tackle the world’s toughest medical challenges.
We
are Novartis. Join us and help us reimagine medicine.
Novartis
are an equal opportunities employer and welcome applications from all suitably
qualified persons.
Your
responsibilities:
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/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.
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