- Title: Medical Writing Quality Control Associate
- Code: RCI-10329
- Location: North Chicago Illinois (IL) 60064
- Posted Date: 01/07/2021
- Duration: 3 Months
- Name:Mangesh Kanade
- Email: email@example.com
- Phone: 908-704-8843 ✖ 260
100 % Remote / Work from home
Spotlight Call Notes:
- Quality Control, specific QC experience with regulatory documents.
- Reviewing docs against source, checking data record in texts or table, figures against source, which is typically a data output report
- 2 – 4 years’ experience, must be in this type of QC work
- Lab QC is not the candidate type needed for this
- Have a four year degree, can be considered a remote position, and does not need to be local to Client.
- In addition to QC work there is documentation that needs to be done
- Uploading docs
- Need someone very organized, working on multiple assignments at one time
- Manage work load independently
- Being organized, detail oriented
- Viva system used, but any experience with other systems is fine
- Pharma background helpful
- QC Reg Docs required…..
- Duration of contract: 1 year initially with potential to renew
- QC of clinical trial documents would be acceptable
- Remote location can be anywhere as long as they are available between core hours of 9 – 3 PM CST
- Clinical study reports are QC’s
- Investigator brochures
- Years of experience/education and/or certifications required: 2 – 4 years exp, BA required, Science/English
Top Five Skills Needed:
- QC experience in Clinical Regulatory documents
- Proficient with MS Office
- Sound communication skills, written and verbally
- Detail oriented is key….
Working independently once trained. Help team members out as needed. Collaborative individuals preferred.
- Responsible for ensuring the quality of clinical regulatory documents by conducting quality control (QC) review utilizing checklists for all applicable documents, providing QC review documentation to Document Management for the Trial Master File (TMF), and, ensuring QC review documentation from all applicable functional areas is completed and provided to Document Management for the TMF per the established business processes and procedures.
- 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.
- 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.