Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Senior Medical Writer II
Job Description
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.
Candidate Profile
• 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.
• 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.
Additional Information
Qualification : M.Pharm, B.Pharm, M.Sc, B.Sc
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Research & Development
End Date : 10th December, 2023
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