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15 days old

Remote Medical Writer Clinical II _ North Chicago, IL

Kelly Services
North Chicago, IL 60064
**Remote Medical Writer Clinical II _ North Chicago, I** L


Kelly Services is currently seeking a Medical Writer Clinical II ( QC Position) for one of our top clients in North Chicago, IL.



**Schedule:** Regular business hours with flexibility on start/end times, 40 hours/work week.


**Duration:** 6 - 12 months with potential of being extended and/or going perm.


**Pay:** $49/hr - $53/hr


**Hours:** some flexibility but core hours need to be 9am 3pm CST.


This candidate will be able to work from home. Location of candidate is completely open. But if Full Time Employment is offered; may need to work some in office.


**PURPOSE**

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.


**RESPONSBILITIES**


+ 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.

+ Reviewing docs against source, checking data record in texts or table, figures against source, which is typically a data output report

+ Working independently once trained. Help team members out as needed. Collaborative individuals preferred.


**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.

+ Quality Control, specific QC experience with regulatory documents.

+ 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.

+ Sound communication skills, written and verbally

+ Detail oriented is key.

+ Strong organizational skills and ability to multitask.

+ Ability to manager workload independently.

+ Viva system experience is a plus, but any experience with other systems will be considered.


Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Email stalvnl@kellyservices.com for questions about the position but please apply online to be considered for the position.


Why Kelly?


+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*


Apply Today!


*Available for purchase and administered by a designated third-party vendor


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-04-28 Expires: 2021-05-29

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Remote Medical Writer Clinical II _ North Chicago, IL

Kelly Services
North Chicago, IL 60064

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