Parexel Released Job Openings On 21/11/2022.PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of expertise-based contract research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries.
Vacancy Details:
Parexel Recruiting graduates with 02+ years experience for Medical Writer Position.Complete Details for the Medical Writer as follows.
Important Details :
- Location : Remote
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: NA
- Opening date for online Application:21/11/2022
- Mode of application :Online
- How To Apply:At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
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Job Description/Skills Required
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 2 years of experience in authoring or supporting PBRER/PSURAuthor 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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