- PCI Pharma Services (Rockford, IL)
- …across our global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives ... properly followed and applied by all appropriate personnel. + Assists the Regulatory Affairs Manager by hosting audits, developing appropriate corrective actions… more
- Edwards Lifesciences (Naperville, IL)
- …to thrive in a dynamic environment where you can make innovative contributions. As a Clinical & Regulatory Affairs Intern with us, you'll find motivation and ... and government agencies in meeting healthcare needs. + Gain hands-on clinical or regulatory experience, working closely with team members to apply medical device… more
- Abbott (Abbott Park, IL)
- …Grants, Medical Advisory Board, and Product Complaints. + Providing input to R&D, QA, Regulatory Affairs , and Clinical Affairs . + Participating in ... and PDA closure). This role is critical in shaping clinical development strategies, guiding regulatory submissions, and...and clinical event committees, in partnership with Clinical Affairs and Product Performance. + Partner… more
- Astellas Pharma (Northbrook, IL)
- …to ensure regulatory compliance and timely submissions. + Partner with drug regulatory affairs , clinical trials unit, clinical development, precision ... IVDR (EU), FDA (IDE, 510(k), PMA), and other global regulatory frameworks (eg, Japan, China) for clinical ...relevant scientific or technical discipline (eg, Life Sciences, Pharmacy, Regulatory Affairs ). Advanced degree is preferred. +… more
- Danaher Corporation (Deer Park, IL)
- …digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work ... m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for regulatory… more
- AbbVie (North Chicago, IL)
- …to clinical development, quality assurance, technology, data management, and regulatory affairs . + Study Management Associate Organization: The Study ... with cross functional teams, including but not limited to data management, regulatory affairs , Clinical Site Management (CSM) and external partners to ensure… more
- AbbVie (North Chicago, IL)
- …to clinical development, quality assurance, technology, data management, and regulatory affairs . + Study Management Associate Organization: The Study ... with cross functional teams, including but not limited to data management, regulatory affairs , Clinical Site Management (CSM) and external partners to ensure… more
- AbbVie (North Chicago, IL)
- …life sciences (eg, biology, biochemistry), bioengineering, biomedical engineering, public health, clinical research, regulatory affairs , biomedical sciences, ... improves the AbbVie Quality System in R&D. The team ensures that clinical research and operations consistently meet regulatory requirements, internal standards,… more
- Astellas Pharma (Northbrook, IL)
- …team meetings, influencing decisions with rigorous statistical insight. + Collaborate with Clinical Development, Medical Affairs , Regulatory , Market Access, ... team supporting evidence generation and decision-making, with responsibility spanning clinical trial statistics, exploratory statistics, medical affairs … more
- AbbVie (North Chicago, IL)
- …to inform business decisions. The team works collaboratively with other departments across clinical development, regulatory affairs , and global medical ... support for various projects and initiatives across all phases of clinical development. The Stats organization is composed of highly skilled statisticians,… more