Novartis Senior Medical Writer II job vacancy at Hyderabad, AP
Senior Medical Writer II
About the role
Senior Medical Writer II
Location – Hyderabad #LI Hybrid
About the Role:
This role is responsible to author, review and independently manage high quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, Informed Consent Form (ICF).
Your key responsibilities:
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.
• Act as project medical writer for various programs in CPOs/global organization and ensure medical writing resource allocation to studies within these programs.
• Supervise outsourcing to external medical writers, if necessary in conjunction with mentoring medical writer. Follow and track clinical trial milestones and resource requirements for assigned projects.
• 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.
Role Requirements
What You’ll bring to the role:
Essential:
• Minimum science degree or equivalent, B.Sc./equivalent with 10 years Clinical Research (CR) experience, M.Sc./M.Pharma +8 years of clinical research (CR).
• Excellent written and oral English Minimum: Minimum science degree or equivalent, B.Sc./equivalent with 10 years Clinical Research (CR) experience.
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Desirable requirements:
• M.Sc./M.Pharma +8 years of clinical research (CR) experience Desired.
• Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent) PhD + 6 year of CR experience, MBBS/equivalent + 6 year of CR.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world
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