Senior Clinical Document Quality Specialist

2 weeks ago


Bengaluru, Karnataka, India Parexel Full time

Job Summary

The Senior Clinical Document Quality Specialist will be responsible for conducting document quality reviews of medical writing deliverables and ensuring timely delivery of error-free, high-quality clinical documents. This includes correcting errors in grammar, style, syntax, and format, ensuring accuracy of clinical data and content presented, identifying and fixing flaws in logic and flow, and following appropriate style guides/templates.

Key Responsibilities

  • Ensure that all work is complete and of high-quality.
  • Edit clinical documents by checking language, grammar, technical terminology, accuracy of data and scientific content.
  • Confirm consistency and integrity across the document.
  • Perform format changes to documents based on guidelines.
  • Ensure that the document adheres to specified style guides or client conventions.
  • Independently perform quality review of assigned documents.
  • Formally document quality review findings for assigned documents.
  • Identify and immediately escalate any significant findings.
  • Participate in resolution of findings with the document authors, and other team members, if necessary.
  • Analyze DQR findings to identify root causes of errors and discrepancies and participate in corrective action planning.
  • Independently produce style guides, manuals, and quality review work guides for various deliverables.
  • Lead the completion of complex tasks by applying technical skills and specialized knowledge to communicate quality check findings.
  • As SME of DQR/QC of clinical documents, lead quality activities, set the standard for enhanced collaboration, delivery of project commitments, and customer satisfaction.
  • Lead the quality review of assigned documents. Where possible, author documents or sections of complex documents.
  • Provide technical leadership to junior colleagues.

Requirements

  • Impeccable written and verbal communication skills and strong command of the English language.
  • Ability to deliver consistently high-quality output.
  • Well-established proof-reading skills and ability to pay rigorous attention to detail.
  • Demonstrate excellent interpersonal skills and proactivity.
  • Take initiative and work in a solutions-driven manner.
  • High level of numeracy, ability to interpret statistical data and an understanding of clinical research concepts would be an advantage.
  • Client-focused approach to work.
  • A flexible attitude with respect to work assignments and new learning.
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
  • Willingness to work in a matrix environment and to value the importance of teamwork.

Preferred Qualifications

  • Experience in the pharmaceutical or clinical research organization industry and medical writing.
  • Knowledge of regulatory documents and ICH-GCP guidelines, understanding of clinical research, and the drug development process.
  • Proof reading, quality control or copyediting experience.
  • Advanced word processing skills, including MS Office; software and systems knowledge or ability to learn and adapt to various IT systems; document management systems, collaborative authoring and file conversion and databases.
  • Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.

Working at Parexel

Parexel is a leading global biopharmaceutical services organization focused on providing a broad range of expertise, capabilities, and tools to support the entire product development process from clinical trials to regulatory and commercialization strategies.



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