- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream ... processing. + Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory , Process Development, Analytical Development, and CDMO technical teams. + Stay… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …to internal and external stakeholders; support Publication strategies. + Support Regulatory submissions . + Facilitate communication between Sales and Marketing, ... closeout of evidence generation activities to support product development, regulatory approval, reimbursement strategies, and overall commercialization of Olympus'… more
- IQVIA (Philadelphia, PA)
- …issues as appropriate. * Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form ... and close-out visits) in accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice (GCP) and International Conference on… more
- Merck (North Wales, PA)
- …commitment to study results transparency in the EU and US (in partnership with Regulatory Affairs) and submissions to CMS for price negotiations for certain ... Medical Education and Training of internal stakeholders; and Compendia and Pathways Submissions + The Associate Director, has an advanced educational background and… more
- Merck (West Point, PA)
- …AS&T and QC teams. + Provide leadership and expertise for preparation of regulatory submissions , inspection readiness, and support health authority inspections - ... troubleshooting where cross-functional investigation is required. + Technical SME for regulatory questions, audit support, reagent changes / supply issues to provide… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …all **pharmacometrics** activities related to pre-IND, IND, phase1-3, PK, PK/PD and regulatory submissions . You will conduct analysis, execution and reporting of ... + Author **pharmacometrics sections** of clinical pharmacology documents for regulatory filings including annual reports, investigator's brochure, IND/NDA applications… more
- Cytel (Harrisburg, PA)
- …all data related deliverables, especially in support of key decision points and regulatory submissions . + Works cross-functionally to ensure the quality of the ... + **Quality & Compliance:** + Ensure all processes and deliverables meet regulatory requirements and internal quality standards. + Support audit readiness and… more
- Organon & Co. (Plymouth Meeting, PA)
- …Provide medical expertise and strategic guidance to support product development, regulatory submissions , and commercialization efforts. + Support business ... objectives. + Collaborate with cross-functional teams, including clinical development, regulatory affairs, marketing and sales, to ensure alignment of medical… more
- J&J Family of Companies (Malvern, PA)
- …for working with teams in the preparation of technical documents and regulatory submissions , participating in review, and contributing to development of ... for all analytical topics including method development, control strategy and regulatory filings supporting FIH through commercial licensure. + Leading the… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream ... processing. + Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory , Process Development, and CDMO technical teams. + Stay current with… more