Great opportunity for Medical Writer @ PAREXEL

  • Full Time
  • Mohali

Website PAREXEL

PAREXEL was indeed a well-known and respected global biopharmaceutical service provider. It is recognized for its contributions to the bio-tech and pharmaceutical industries, helping in the development of new drugs and treatments on a global scale. PAREXEL offers knowledge-based contract research, medical communications, and consulting services across various therapeutic areas to pharmaceutical, biotechnology, and medical device companies worldwide.

The company’s services encompass a wide range of activities related to clinical trials and drug development, including clinical research, data management, regulatory affairs, pharmacovigilance, medical writing, and strategic consulting. They work closely with clients to provide customized solutions that meet their specific needs throughout the drug development lifecycle.

Job Title: Medical Writer II

Job Purpose: The Medical Writer II will be responsible for researching, creating, editing, and coordinating the production of Periodic Benefit-Risk Evaluation Reports (PBRER) and Periodic Safety Update Reports (PSUR) for submission to regulatory authorities.

Job Description:

  1. Author PBRER/PSUR:
    • Take ownership of the end-to-end authoring process for PBRER/PSUR.
    • Gather, review, analyze, and evaluate relevant resources to prepare, develop, and finalize PBRER/PSUR for submission to regulatory authorities.
    • Incorporate feedback from team members to revise PBRER/PSUR drafts and ensure all relevant input is included.
    • Author Safety sections for the PBRER/PSUR and perform case level analysis of the retrieved cases.
    • Adhere to required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions, and other applicable processes.
  2. Quality Control:
    • Ensure all work is complete and of high quality before distribution to the team or submission to the client.
    • Confirm data consistency and integrity throughout the document.
    • Prepare documents for publishing readiness, as required.
    • Ensure document structure, content, and style adhere to FDA/EMA or other appropriate regulatory guidelines, as well as departmental, corporate, or client SOPs and style guidelines.
    • Offer alternative content suggestions when contributors provide content that does not meet document requirements.
    • Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution, encompassing both copyediting and content review.

Candidate Profile:

  • The Medical Writer II must have a minimum of 3 years of experience in authoring or supporting PBRER/PSUR reports.
  • Location: Mohali
  • Industry Type: Pharma / Healthcare / Clinical research
  • Job ID: R0000008460
  • End Date: 20th August 2023

Additional Information:

  • Experience: 3 years of experience
  • Location: Mohali
  • Industry Type: Pharma / Healthcare / Clinical research
  • Job ID: R0000008460
  • End Date: 20th August 2023

If you are interested in this Medical Writer II position and meet the candidate profile requirements, please consider applying before the specified end date.

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