Document Controller / Information Management Specialist

Job Description

As a Document Quality Reviewer II at Parexel, you play a crucial role in ensuring the accuracy and quality of medical writing deliverables for clinical documents. Your responsibilities include:- Conducting document quality reviews to correct errors in grammar, style, syntax, and format.- Ensuring timely delivery of error-free and high-quality clinical documents.- Editing clinical documents to check language, grammar, technical terminology, data accuracy, and scientific content.- Independently performing quality reviews of various clinical components of assigned documents.- Identifying flaws in logic and flow and following appropriate style guides/templates.- Documenting quality review findings using department specific procedures.- Analyzing findings to identify root causes of errors and discrepancies for corrective action planning.- Providing editing support for more complex clinical documentation.- Participating in departmental or interdepartmental process improvement and training initiatives.Your qualifications and experience should include:- Impeccable written and verbal communication skills with a strong command of the English language.- Ability to deliver consistently high-quality output with well-established proofreading skills.- High level of numeracy, ability to interpret statistical data, and understanding of clinical research concepts.- Experience in the pharmaceutical or clinical research organization industry and medical writing.- Knowledge of regulatory documents, ICH-GCP guidelines, and the drug development process.- Proofreading, quality control, and copyediting experience.- Advanced word processing skills including MS Office and ability to adapt to various IT systems.Qualifications Required:- Bachelors degree in Life Sciences/Health Related Sciences or equivalent.- Approximately 4 years of relevant experience.At Parexel, we are dedicated to improving the worlds health through our clinical development solutions. Join us in our mission and contribute to the development of therapies that benefit patients worldwide. As a Document Quality Reviewer II at Parexel, you play a crucial role in ensuring the accuracy and quality of medical writing deliverables for clinical documents. Your responsibilities include:- Conducting document quality reviews to correct errors in grammar, style, syntax, and format.- Ensuring timely delivery of error-free and high-quality clinical documents.- Editing clinical documents to check language, grammar, technical terminology, data accuracy, and scientific content.- Independently performing quality reviews of various clinical components of assigned documents.- Identifying flaws in logic and flow and following appropriate style guides/templates.- Documenting quality review findings using department specific procedures.- Analyzing findings to identify root causes of errors and discrepancies for corrective action planning.- Providing editing support for more complex clinical documentation.- Participating in departmental or interdepartmental process improvement and training initiatives.Your qualifications and experience should include:- Impeccable written and verbal communication skills with a strong command of the English language.- Ability to deliver consistently high-quality output with well-established proofreading skills.- High level of numeracy, ability to interpret statistical data, and understanding of clinical research concepts.- Experience in the pharmaceutical or clinical research organization industry and medical writing.- Knowledge of regulatory documents, ICH-GCP guidelines, and the drug development process.- Proofreading, quality control, and copyediting experience.- Advanced word processing skills including MS Office and ability to adapt to various IT systems.Qualifications Required:- Bachelors degree in Life Sciences/Health Related Sciences or equivalent.- Approximately 4 years of relevant experience.At Parexel, we are dedicated to improving the worlds health through our clinical development solutions. Join us in our mission and contribute to the development of therapies that benefit patients worldwide.

Keyskills :
ProofreadingQuality ControlMedical WritingClinical ResearchMS OfficeCopyeditingRegulatory DocumentsICHGCP GuidelinesDrug Development Process