- Merck (North Wales, PA)
- …applied to designing and analyzing clinical trials in support of worldwide regulatory submissions . This position involves interaction with Medical, Data ... Management, Data Science, Numerical Analysis, Physiology, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions , Scientific Modeling,… more
- Merck (West Point, PA)
- …transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The ... filing readiness and supports preparations for agency meetings. Authors and reviews regulatory submissions . + Drives continuous and phase appropriate process… more
- Pfizer (Collegeville, PA)
- …other statisticians, study managers, alliance partner colleagues - for assigned studies and regulatory submissions . + Provide input to the Statistics Group Lead ... result interpretation, and providing statistical support and leadership in global regulatory submission activities, as well as implementing new initiatives and… more
- University of Pennsylvania (Philadelphia, PA)
- …related activities delegated to research coordinator who provides study related support (eg, regulatory submissions and data entry). + May be responsible for ... activities delegated to research coordinators/assistants who provide study related support (eg, regulatory submissions and data entry). May be responsible for… more
- Merck (West Point, PA)
- …internal and external manufacturing sites, process validation, and authoring of regulatory submissions . For commercial programs, activities include site-to-site ... process performance qualification, risk assessment, control strategy, process comparability reports, and/or regulatory submissions such as BLAs, INDs, or other … more
- Merck (West Point, PA)
- …control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions . + **CMC RA** : Experience supporting/writing ... Mentorship, Process Characterization, Process Control, Process Design, Process Optimization, Regulatory Submissions , Risk Consulting, Risk Management, Science {+… more
- Sumitomo Pharma (Harrisburg, PA)
- …medical writing-to maintain the statistical integrity of study conduct. + Support regulatory submissions by preparing responses to agency inquiries and ... Safety (ISS) and Integrated Summary of Efficacy (ISE) strategy for NDA/BLA submissions , ensuring compliance with regulatory expectations. + Collaborate closely… more
- Teva Pharmaceuticals (West Chester, PA)
- …assays. This role requires close collaboration with cross-functional teams to support regulatory submissions . This role reports to the head (Senior Director) ... of regulatory guidance and quality standards; experience authoring and reviewing regulatory submissions and responses as well as other interactions with… more
- Deloitte (Pittsburgh, PA)
- …Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years experience leading, ... like GenAI, AI/ML, and automation for analytical methods, manufacturing, regulatory and/or QA/QC + Implementation of regulatory ...with CMC modules (Module 3 of CTD/eCTD) for global submissions , as well as familiarity with ICH guidelines (ie:… more
- Geisinger (Danville, PA)
- …for management of research projects including protocol development and implementation, regulatory submissions and adherence, project planning, project tracking ... annual departmental and study budgets, as applicable. + Responsible for all regulatory documents and reporting requirements of studies. + Coordinates and conducts… more