PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Post : Medical Writer II
Job Purpose : Under departmental supervision, the Medical Writer will research, create, edit, and coordinate the production of PBRER/PSUR for submission to regulatory authorities.
Job Description
Author PBRER/PSUR
• End-to-end authoring of PBRER/PSUR
• Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize PBRER/PSUR for submission to regulatory authorities.
• Revise PBRER/PSUR drafts based on the review comments from team members to ensure inclusion of all relevant input.
• Author Safety sections for the PBRER/PSUR and perform case level analysis of the retrieved cases
• Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable.
• Perform literature reviews to obtain background information pertaining to the safety topic analysis.
Quality Control
• Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
• Confirm data consistency and integrity across the document.
• Prepare documents for publishing readiness, when applicable.
• Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable.
• Provide suggested alternative content when contributors provide content that does not meet document needs.
• Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
Candidate Profile : The Medical Writer must have minimum 3 years of experience in authoring or supporting PBRER / PSUR
Additional Information
Experience : 3 years of experience
Location : Mohali
Industry Type : Pharma / Healthcare / Clinical research
Job ID : R0000008460
End Date : 20th September, 2023
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