Parexel Released Job Openings On 28/02/2022.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 Any Graduates with 2-7+Years relevant Experience Experience with a Clinical research Organization or a Pharmaceutical Company is preferred for Medical Writer I/ll Position.Complete Details for the Medical Writer I/ll as follows.
Important Details :
- Location : Remote (Hiring office located in Mohali/SAS Nagar)
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary:  ₹ 6,00,000 – 12,00,000 P.A.
- Opening date for online Application: 28/02/2022
- Mode of application :Online
- How To Apply: If interested, kindly reply with your updated profile to ajay.kumar2@Parexel.com to pursue further.
Related Job : QA,QC,R&D,Production,Sales,Packing,RA,Engineering,Medical Coding,Purchase,Stores Jobs
Job Description/Skills Required
- 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/PSUR
Key Accountabilities: - AccountabilitySupporting Activities
- Author PBRER/PSUR
- Â 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.
- Â Quality ControlEnsure that all work is complete and of high quality prior to team distribution or shipment to client.
oConfirm data consistency and integrity across the document.
oPrepare documents for publishing readiness, when applicable.
oEnsure 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.
oProvide 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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