Job Description
Perform data quality check of clinical regulatory and scientific documents (CSR, Protocol, IB, DSUR, clinical overview and summaries and other regulatory documents.) to check accuracy of the content against source documents (eg. TLFs, literature references, other referenced documents).
Identify data errors and inconsistencies in documents.
Check documents for correct use of punctuation, spellings, grammar etc.
Ensure adherence to template and guidelines.
Update the data for clinical regulatory & scientific documents as per specifications and instructions from client when required.
Document Publishing & Management:
Manage documents in electronic repositories as per client specifications.
Perform formatting of word documents in depth as per client and regulatory specifications.
Create Redline/ Track change version (if applicable – IB update, Protocol amendments) as per client and regulatory specifications.
Perform pre-publishing and publishing activities of clinical regulatory & scientific documents to ensure submission readiness.
Perform submission readiness for literature references as per client specifications and guidelines. As well support in addition of citations to the Endnotes.
Redaction:
redaction (redact PPD & CCI information) of clinical and scientific documents per the applicable regulatory requirements, sponsor processes and guidance in regulatory documents. Prepare the necessary justification table supporting & justifying the redactions marked/applied
Identify data errors and inconsistencies in documents.
Check documents for correct use of punctuation, spellings, grammar etc.
Ensure adherence to template and guidelines.
Update the data for clinical regulatory & scientific documents as per specifications and instructions from client when required.
Document Publishing & Management:
Manage documents in electronic repositories as per client specifications.
Perform formatting of word documents in depth as per client and regulatory specifications.
Create Redline/ Track change version (if applicable – IB update, Protocol amendments) as per client and regulatory specifications.
Perform pre-publishing and publishing activities of clinical regulatory & scientific documents to ensure submission readiness.
Perform submission readiness for literature references as per client specifications and guidelines. As well support in addition of citations to the Endnotes.
Redaction:
redaction (redact PPD & CCI information) of clinical and scientific documents per the applicable regulatory requirements, sponsor processes and guidance in regulatory documents. Prepare the necessary justification table supporting & justifying the redactions marked/applied
💡 Quick Summary
Seeking a career-building opportunity? The Principal Document Publisher Clinical Medical Editor position is now open for candidates interested in the Driver Jobs sector. This role in Thane offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Driver Jobs is a plus.
