Parexel – Hiring B.Pharm, M.Pharm, BDS, M.Sc, Pharm.D Candidates – Apply Now

At Parexel, we all share the same goal – to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special – a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.

Parexel is Hiring

  • Position: Medical Writer II
  • Qualification: B.Pharm, M.Pharm, BDS, M.Sc, Pharm.D
  • Experience: 3years
  • Apply Link :

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:


Supporting Activities


  • 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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