Malone
Job ID: 331112
Pay: $28
Shift: 1st (8a-5p M-F)
Location: Lake Zurich, IL (Hybrid – onsite 2 days per week)
Position Type: 9-mo. contract with possible extension.
In this role, you will ensure that our client, a well renown healthcare company meets all state, local, federal, international, and industrial regulations that apply to their products.
- Manage and submit regulatory permit and notification applications to USDA to import, move and release regulate plant materials.
- Assess study results for adherence to 40 CFR EPA regulatory requirements.
- Stay abreast of developments in GCP and federal regulations regarding clinical research.
- Assist with QC and QA of various study relate regulatory documents and reports.
- Assist with training and mentoring of junior regulatory specialists and assist with departmental QC and QA activities.
- Serve as QA reviewer for application user manuals.
- Gain a great deal of experience with new drugs and therapies in the field of oncology.
- Improve on the strain relationship between QA and manufacturing with soft people’s skills and communication.
- Develop and deliver regulatory training of safety, chemical hazards, work instructions, human resources, quality, and ISO.
- Facilitate activities surrounding institution closure, including patient transfer, study archival, and IRB notifications.
- Utilize SharePoint to manage the document change control process and maintain configuration control.
- Serve as regulatory contact person for representatives from sponsoring pharmaceutical and device firms and FDA for review of regulatory records.
- Perform quality checks to ensure compliance with FDA regulations regarding electronic submissions and maintain expert knowledge of internal/external publishing standards.
Education & Background Requirements
- High School Diploma or higher.
- Microsoft Word
- Adobe Acrobat
- Knowledge on Bookmarking, hyperlinking.
- Regulatory Publishing Experience in pharmaceutical industry (2-4 yrs preferred)
- Previous work experience in Pharmaceuticals is preferred.
- Strong Communication skills
- Organized, detail-oriented.
- Be a Team-player
- DocuBridge
- NDA/ANDA/IND
- FDA guidances
- eCTDManager
APPLY TODAY!
Malone Workforce Solutions is an equal opportunity employer.
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