Post Name Medical Writer Date August 09, 2023 Short Info. Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster.
Parexel Recruitment 2023 Overview
| Company Name | Parexel |
| Post Name | Medical Writer |
| Job Type | Full Time Job |
| Experience | 0 to 2 years |
| Function/Business Area | Airlines |
| Location | Hyderabad |
| Category | sales |
| Official Website | Parexel |
| Salary | UPTo 3.0LPA + Incentives |
About Parexel Company
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster.
Under departmental supervision, the Medical Writer will research, create, edit, and coordinate the production of PBRER/PSUR for submission to regulatory authorities.
Why You Should Join
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.
Education Requirement
Bachelor’s Degree
Skills Requirement
- 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.