- Title: Medical Writing Quality Control Associate
- Code: RCI-08732
- Posted Date: 07/06/2020
- Duration: 3 Months
- Name:Sumit Rawat
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
Medical Writing Quality Control Associate II
Assignment will initially be 3 months and then will extend in 6 month increments.
Make sure the candidates have the QC of Clinical documentation experience, where they are checking data against source documents and not just experience is checking that the documents are complete prior to uploading into the vault.
This is not laboratory QC work but documentation role.
- 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 (TLGs).
- Deliver documented quality review comments/checklist to document author through resolution.
- Ensures 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.
- 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 competencies 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.
- Important must have
- Intake Notes
- Experience in being flexible with changing workload that requires prioritization and planning to support immediate/urgent business needs.
- 2-4years relevant pharmaceutical industry experience in medical writing, clinical research, quality, or related area such as regulatory or product support.
- Bachelor's degree (BA/BS) required.
- Experience in quality review of clinical regulatory documents.
- Proficient experience in use of MS Office (e.g., Word, Excel, Outlook, PowerPoint) and Adobe Acrobat.
- Are you open to look at candidates willing to relocate? Can work remote entire assignment
- Note Virtual Interview process to be followed: Phone followed by team/panel interviews.
- Years of experience/education and/or certifcations required: 2 – 4 years exp, BA required, Science/English
- What are the top 3-5 skills requirements should this person have?
- QC experience in Clinical Regulatory documents
- Proficient with MS Office
- Sound communication skills, written and verbally
- Detail oriented is key….
- What type of environment is this person working in? Combination of Group/Individual work? Working independently once trained. Help team members out as needed. Collaborative individuals preferred.
- Work Schedule (Define days,# of hours)/ Is Overtime offered or required: Reg Bus hours
- Is there flexibility in their daily schedule?Flexibility to start and end dates/times….
- Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)? Post COVID: Onsite once return to work is implemented. Would come into office if local candidate to be able to meet and work directly with team. But want to consider remote candidates to ensure the best are considered.
- Travel? No.