- Merck (North Wales, PA)
- …innovative medicines, and we work with cross-functional colleagues in Global Medical and Scientific Affairs and Global Policy to ensure timely and equitable ... process (mainly Phase 2-3) including study design, medical monitoring, and medical/ scientific interpretation of study analyses, regulatory reporting, and… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... a scientific or technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory … more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …external engagement across therapeutic areas + Collaborate with global and US Medical Affairs teams to ensure alignment with scientific and commercial priorities ... The Senior Manager, External Engagement Strategic Planning will play...executing strategic initiatives that enhance the impact of Medical Affairs external stakeholder engagement activities (including those of the… more
- Merck (North Wales, PA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. **Specifically, The Senior Director May… 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 ... with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD...programs after proof of concept through late-stage trials and regulatory submissions. + Provide medical and scientific … more
- J&J Family of Companies (Spring House, PA)
- …Design, Process Hazard Analysis (PHA), Process Optimization, Program Management, Regulatory Affairs Management, Research and Development, Risk Management, ... Pre-Clinical/Clinical Development **Job Sub** **Function:** Nonclinical Safety **Job Category:** Scientific /Technology **All Job Posting Locations:** San Diego, California, United… more
- Merck (Upper Gwynedd, PA)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) + ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Olympus: https://www.olympusamerica.com/careers . **Job Description** As part of the Medical and Scientific Affairs group, an integral delivery unit within the ... Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable...and completeness of clinical trial data in compliance with regulatory standards, SOPs, and Good Clinical Data Management Practices… more
- J&J Family of Companies (Spring House, PA)
- …serving on multifunctional teams delivering clinical trials in an R&D or Medical Affairs setting. + Proficiency with regulatory submissions and interaction. + ... company of Johnson & Johnson is recruiting for a ** Senior Director, Head of Hematology R&D Data Science &...Science-related projects for the CDTs. This will include both regulatory -grade and observational research. + Identify and procure data… more
- 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 ... + Development of sound mechanical, pre-clinical, and clinical data of scientific merit on all technologies developed + Oversee product development activities… more