job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!
location: Waukegan, Illinois
job type: Contract
salary: $25.00 - 30.91 per hour
work hours: 9 to 5
- Individual will work in Company's global quality organization processing clinical and/or postmarket, medical device and combination product reports for complaints and communicating with global health authorities regarding inquiries.
- Interface with internal and external Company customers such as physicians, nurses, pharmacists, hospital personnel, risk managers, purchasing agents, sales representatives, general public, manufacturing sites, technical support, commercial organization and PV regarding Company product complaints.
- Responsible for product complaint documentation, investigations and identification of reportable adverse events and potential reportable events.
- Responsibilities will include creation and submission of regulatory reports and third party interface.
- Review global medical device and combination product complaints for the identification of reportable events in the local countries and for any reciprocal reporting requirements.
- Responsible for the submission of US MedWatch reports and ensuring ex-US reportable events are reviewed prior to submission and submitted within the required timeframes.
- Complaint documentation meets Good Documentation Practices. This requires good analytical skills, technical writing and good documentation. Responsible to ensure complaint files meet global regulatory requirements.
- Responsible for on time reporting of Medical Device Reports (MDR) and Medical Device Incident Reports (MDIR) globally.
- Run daily/weekly reports to track progress of reporting activities and to review new incoming information for any changes to reportability of a compliant.
- Interface with Third Party Manufacturers, health care professionals, general public, internal customers, Company functional areas and regulatory agencies.
- Potential oversight of management of a project team or participation on a project team involving process improvements, new product launches, issue resolutions, etc.
- Potential Responsibility of a specific section of the complaint process and employees activities involved with that processing step.
- Knowledge of FDA Quality Systems, pre and post market product compliant handling and Medical Device Reporting regulations (21 CFR 803, 820) is preferred.
- Comprehensive knowledge and application of computer system software including Excel, Word, and complaint management systems.
- Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
- Ability to prioritize workflow to ensure compliance with regulations and standard operating procedures.
- Solid written/verbal communication and organizational skills.
- Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.
- Bachelor's Degree preferred; preferably in nursing, medical technology, (MLT, LPN, RN).
- 5+ years of work experience in a cGMP related industry or in a clinical setting (preferred)
skills: FDA, MS-EXCEL, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.