Job Purpose: Under departmental supervision, the Medical Writer will research, create, edit, and coordinate the production of PBRER/PSUR for submission to regulatory authorities.

The Medical Writer would serve as the primary client contact.

The Medical Writer must have minimum 3 years of experience in authoring or supporting PBRER/PSUR

Key Accountabilities:

Accountability

Supporting Activities

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.