Senior Medical Regulatory Writer

About the role

skills : As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applications) electronic document management (preferably Veeva-vault), Knowledge of periodic safety…

What you'll do

• Write and/or edit high-quality documents for submission to regulatory authorities to support marketing authorization applications, renewals
• Delivery of high-quality documents on time and in compliance with internal and external standards and guidelines
• Works on documents with some supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews
• Essential Job duties and
• Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer

What you need

• 5–9 yrs of experience
• Stakeholder management
• Writing
• Pharmacovigilance
• Operational risk
• M.Pharm or D.Pharm or PhD or MBBS or BDS

Good to have

• Editing
• GCP