Regulatory Documentation Reviewer

Proclinical is currently recruiting for a Regulatory Documentation Reviewer with a biopharmaceutical company located in Durham, NC.

Job Responsibilities:

• Must be familiar with ICH and GCP Guidelines.
• Must demonstrate good interpersonal and organizational communication skills.
• Determines scope of QC review with the document author and the source documents and/or data required (in addition to utilizing any applicable checklist).
• Conducts independent quality review of documents by checking against source (documents and/or data) to ensure that the results presented are accurate (emphasis on checking the numbers/data in the text and in-text tables against the final statistical tables, listings, and graphs).
• Deliver documented quality review comments/checklist to document author through resolution.
• Ensures QC review documentation from all applicable functional areas is completed and uploaded to the TMF per the established business processes and procedures.
• Maintains strong knowledge of clinical regulatory documents requiring QC as well as business processes and procedures for these documents. Demonstrates strong attention to detail and a high level of quality, consistency, and accuracy in work effort.
• Accountable for meeting the main objectives of the assigned projects/roles and responsibilities within established timelines and with an appropriate quality level.
• Drives the QC of clinical regulatory documents to timely completion.
• Accountable to Senior Manager, Medical Writing. Exhibits a moderate level of technical competency and requires a low level of counsel and guidance.
• Mentors and provides guidance/training to less senior MW QC staff as applicable.
• Expedient escalation of issues to management is essential and may have a direct impact on the ability to meet project timelines.
• Daily interaction with Medical Writers and/or Medical Writing managers as well as interface/communication with applicable cross-functional areas. Communicates and provides deliverables to Medical Writers, Medical Writing managers, and others as applicable.

Skills and Requirements:

• Bachelor's degree (BA/BS) required.
• 2-4 years relevant pharmaceutical industry experience in medical writing, clinical research, quality, or related area such as regulatory or product support.
• Experience in quality review of clinical regulatory documents.
• Experience in being flexible with changing workload that requires prioritization and planning to support immediate/urgent business needs.
• Proficient experience in use of MS Office (e.g., Word, Excel, Outlook, PowerPoint) and Adobe Acrobat

If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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