Medical Writer Ii

2 weeks ago

Mohali, India Parexel Full time

Mohali, India

**Job ID** R0000008460

**Category** Medical Writing

**ABOUT THIS ROLE**:
**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.

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