Medical Writer

About the role

This role involves supporting brand clearance, prosecution, new brand registration, trademark renewal, litigation, and domain name misuse activities. The team member plays a proactive role during outdoor seizure operations in case of misuse of a brand logo by Infringer.

What you'll do

• Develop and update process documents, SOPs and trackers for Medical Writing Function
• Prepare, review and edit clinical trial protocols, investigator’s brochure (IB), Case Report Form (CRF)
• Prepare, review and edit Clinical Study Report (CSR), executive summary and study-specific logs
• Ensure all study documents like protocol, ICD, CRF, patient diaries & CSRs are prepared in alignment with ICH-GCP
• Conduct quality check (QC) of protocols, protocol amendments, CRF, ICD, CSR and other relevant documents

What you need

• 3–5 yrs of experience
• Clinical research
• Pharmacology
• CRO
• Biology
• Regulatory affairs
• SOP writing
• Any graduate

Good to have

• IPR
• Litigation