- Merck & Co. (North Wales, PA)
- …Phase 2-3) including study design, medical monitoring, and medical /scientific interpretation of study analyses,- regulatory reporting, and publication.-The ... Disease, Infectious Disease Research, Intellectual Curiosity, Interdisciplinary Problem Solving, Medical Research, Pharmacovigilance, Regulatory Compliance, Regulatory… more
- Merck & Co. (North Wales, PA)
- …business acumen and expertise in data and data standards across Clinical Development, Medical Affairs, and Regulatory Affairs domains. Apply domain knowledge to ... governance standards for data quality, data lineage, security, and regulatory adherence. Conduct gap assessments between current-state and target-state… more
- Merck & Co. (North Wales, PA)
- …across multiple stakeholders including sales, marketing operations, Learning and Development, Legal, Regulatory , Medical , etc. They will develop and track key ... applicable.We offer a comprehensive package of benefits.- Available benefits include medical , dental, vision healthcare and other insurance benefits (for employee… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe US Director of Medical Affairs (DMA) for Gynecologic Malignancies (Ovarian, Endometrial and Cervical Cancer) holds primary responsibility for the ... development and execution of regional oncology Medical Affairs strategies and plans for Gynecological Malignancies in the US across indications.- The US DMA for… more
- Merck & Co. (North Wales, PA)
- …state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and ... projects in Late Development Statistics.Lead the interaction with Clinical, Regulatory , Statistical Programming, Data Management, and other Scientists from our… more
- Eisai, Inc (Philadelphia, PA)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards. This… more
- Merck & Co. (North Wales, PA)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline of ... AAV, lentiviral, gene editing, cell-based therapeutics), a strong understanding of regulatory requirements, and the ability to work cross-functionally in a… more
- Merck & Co. (North Wales, PA)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... of clinical development, including study design, initiation, execution,-monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Merck & Co. (Upper Gwynedd, PA)
- …clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
