What are the responsibilities and job description for the Medical Writer II Job at PAREXEL in King Of Prussia position at PAREXEL?
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 / PSURKey Accountabilities : AccountabilitySupporting ActivitiesAuthor PBRER / PSUREnd-to-end authoring of PBRER / PSURGather, 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 casesFollow 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 ControlEnsure 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.
