- Globus Medical, Inc. (Audubon, PA)
- …technique guides, brochures and other marketing/sales support materials + Partner with Regulatory Affairs in planning, coordination, writing, and execution of ... to adequately represent and reflect company philosophy to customers, investors, regulatory agencies, and industry peers + Proficient in preparation of reports… more
- J&J Family of Companies (Spring House, PA)
- …project teams as well as functional area partners in Discovery, Late Development, Regulatory Affairs , Epidemiology, Market Access, Medical Affairs and other ... science, pharmacoepidemiology and digital health + Knowledge of Immunology and the regulatory landscape + Experience with healthcare datasets, such as EHR, or… more
- Charles River Laboratories (Wayne, PA)
- …listed above. + Certification/Licensure: None. + _Other:_ Knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is ... Testing Solutions With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for… more
- Sanofi Group (Swiftwater, PA)
- …for health agencies in support of drug development, or equivalent experience in Regulatory Affairs or Medical Affairs . Knowledge of Vaccine Clinical ... the scope of the assigned franchise, prepared in accordance with regulatory specifications and strategic messaging to support the clinical development, marketing… more
- J&J Family of Companies (Spring House, PA)
- …and external human data resources. + Partner with Clinical Development, Global Regulatory Affairs , Data Science, Patient Reported Outcomes, Statistics and other ... core functions in Precision Measures (including Biomarkers & Imaging) to contribute to holistic measurement plans (across molecular, imaging, digital, clinical and other measures) for our compounds in development. + Develop relationships with key scientists… more
- J&J Family of Companies (Spring House, PA)
- …Measurement, Process Hazard Analysis (PHA), Process Optimization, Program Management, Regulatory Affairs Management, Research and Development, Risk Management, ... by generating hypotheses and investigative strategies. + Accountable for global regulatory nonclinical documents and health authority responses to support clinical… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …Provide application support and expertise to both end-customers and internal functions ( regulatory affairs , R&D, customer service and product management). + ... Build and cultivate a steady flow of KOL advisers and new product testers in Lifesciences / academia, Pharma/Biotech, and clinical markets globally. + Lead innovative work in the lab/factory or with the customer's lab to develop application protocols for… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of...Manufacturing and Controls (CMC), medical affairs and business development are critical to the success… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the… more
- ThermoFisher Scientific (Allentown, PA)
- …programs and operational practices. + **Stakeholder Alignment:** Interact with Regulatory Affairs , Clinical, Quality, Pharmacovigilance and Legal teams ... depend on - now and in the future. ROLE: Regulatory Intelligence Manager LOCATION: Fully Remote, East Coast is...Remote, East Coast is highly preferred **Position Summary** The Regulatory Intelligence Manager will play a pivotal role in… more