- Penn Medicine (Plainsboro, NJ)
- …supervision and direction in regards to all administrative, financial, regulatory , quality , human resources, patient/employee satisfaction, and clinical ... all areas of accountability are compliant with all federal, state and local regulatory standards and requirements, including DOH, TJC, FDA , HIPAA, HCFA, DPW,… more
- Cardinal Health (Trenton, NJ)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and ... to update manufacturer knowledge such as IPD Analytics, Evaluate Pharma, IQVIA, Medi-Span, FDA Orange and Purple Books, and more. + Conduct secondary research (eg,… more
- System One (Princeton, NJ)
- …experiments, analyze data, draw conclusions, and recommend actions + Basic knowledge of FDA regulatory requirements for OTC products + Ability to prioritize and ... policies for working in the laboratory designated for the development of FDA regulated products + Assist in maintaining laboratory compliance including equipment… more
- Terumo Medical Corporation (Somerset, NJ)
- …with medical, regulatory and legal partners to assure compliance with FDA regulations US laws and appropriate clinical representation of assets. + Administer ... Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for… more
- Integra LifeSciences (Plainsboro, NJ)
- …established costs, quality , and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the ... and maintenance problems to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all… more
- Integra LifeSciences (Plainsboro, NJ)
- …established costs, quality , and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the ... and maintenance problems to ensure minimum costs, prevent operational delays, and maintain quality and regulatory compliance standards. + Trains and ensures all… more
- Sanofi Group (Morristown, NJ)
- …leading and overseeing all statistical work for clinical development and regulatory submissions, leading a team focused on clinical development strategies, ... Head partners closely with clinical teams, Clinical Sciences & Operations (CSO), regulatory experts, and key stakeholders to accelerate the delivery of medicines to… more
- J&J Family of Companies (Titusville, NJ)
- …globally. Through this approach, we have become the industry leader in productivity, FDA approvals and breakthrough designations, with 13 new products since 2011 and ... final protocols, clinical study reports, and clinical components of regulatory packages/submissions. He or she may delegate some of...the clinical research staff within NP, assuring the high quality of work produced, and that the staff is… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory , Outsourced Manufacturing and Project ... Escalates to senior leadership as needed . Partners with Quality Assurance to resolve quality -related issues with...co-meds for clinical studies . Mature knowledge of the FDA , cGMP, GCP standards and regulatory guidance… more
- Merck (Rahway, NJ)
- …the Rahway (RY) NJ Campus. This role ensures HVAC systems comply with regulatory standards (eg, FDA , cGMP), maintain optimal environmental conditions for product ... HVAC operational strategies that ensure compliance with GxP (as applicable) and other regulatory requirements. + Lead the operation of the site BAS and HVAC control… more