- Piper Companies (Philadelphia, PA)
- Piper Companies is currently seeking a Sr. Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA ... (Hybrid Schedule). Responsibilities for the Sr. Regulatory Operations Specialist . Coordinate diverse regulatory submissions by collaborating with internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Aequor (San Diego, CA)
- US Regulatory Affairs Lead SCOPE OF RESPONSIBILITIES: He/She will be responsible for representing regulatory function to approve promotional material He/She will ... to drive decision making working across regional teams DUTIES: Work with regulatory leads through cross-functional team support on both strategic and tactical… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: US Managed Markets Senior Specialist The Senior Specialist will work closely with US Commercial teams as a key financial and ... and growth of our Company' s Human Health business. The Senior Specialist is responsible for forecasting, month-end close, budgeting, and financial evaluation… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Control Senior Specialist plays a critical role in ensuring the quality of our products by managing laboratory data and overseeing the ... to support manufacturing processes. Responsibilities of the Quality Control Senior Specialist include leading routine testing of products, driving continuous process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global function on study and project teamsProduces independent writing for publications and regulatory documentsServes as a specialist in PK-PD and Pop PK-PD ... function on study and project teams, and participate in and contribute to regulatory and KOL meetings. This position requires significant understanding of PK-PD and… more
- BioAgilytix (Durham, NC)
- …therapeutics to the patients who need them.The Senior Laboratory Automation Specialist will be primarily responsible for overseeing the programming and ... liquid handlers, robotic arms, and automated assay platforms.Familiarity with regulatory requirements for laboratory operations, including GLP and GMP.Exceptional… more
- Merck & Co. (Durham, NC)
- …with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract ... customers and patients on time, every time, across the globe.The Specialist is responsible/accountable for Incoming Quality activities, including: Sampling and… more
- Merck & Co. (North Wales, PA)
- …Research & Development organization at our company. Position Description/Summary The Senior Specialist , Project Manager is a core member of Early Drug Development ... and execute our Company's drug and vaccine development efforts. The Senior Specialist is expected to provide project management leadership and drive cross-functional… more
- Merck & Co. (Durham, NC)
- …years; currently Durham employs 1,000+ people. This role as an Operations Specialist will be an energetic individual with strong interpersonal, leadership, and ... manufacturing and related systems (ie SAP) Familiarity with pharmaceutical regulatory requirements Project management and data analysis skillsTechnical writing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global function on study and project teamsProduces independent writing for publications & regulatory documentsServes as a specialist in PK-PD and Pop PK-PD ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Merck & Co. (Durham, NC)
- …medicines and vaccines, including our HPV vaccines. - The Senior Engineering Specialist will troubleshoot and maintain process and process support equipment utilized ... plant maintenance and spare parts procurement systems. Working knowledge of regulatory requirements in accordance with GMP manufacturing operations Ability to work… more
- Eisai, Inc (NJ)
- …consistency of case records and documentation. Creates and ensures distribution of regulatory reports for FDA and other regulatory health authorities Essential ... submissions to regulators, co-marketing partners and affiliates within company and regulatory timeframes. Utilize ARISg for all reporting and confirmation of… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at our Boulder, ... The Position Novo Nordisk is seeking a highly motivated analytical support specialist to join the Analytical Development team in Boulder, CO. The candidate… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QC Specialist , Lab Services - I, II, III as part of the Quality team based in ... Raritan, NJ. Role Overview The QC Specialist , Lab Services, is responsible for sample management. The...handle corrective and preventative action records. Supports internal and regulatory audits. Requirements A minimum of a Bachelor's degree… more
- Eisai, Inc (Nutley, NJ)
- …mild cognitive impairment due to Alzheimer's disease (AD) or mild AD. TheNeurology Account Specialist (NAS) will be part of a diverse team of sales professionals who ... sales/business analytics, etc.)Strong understanding of pharmaceutical manufacturer compliance & regulatory requirementsDemonstrated success in driving growth and profitability, establishing… more
- Aequor (San Diego, CA)
- …certain post-marketing commitments and ensuring compliance with global regulatory requirements.Position Summary / ObjectiveAppropriately perform core signal ... queries and contribute to specified PV sections. Ensure pharmacovigilance regulatory compliance with oversight, as needed.Position ResponsibilitiesParticipate in related… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Reviews and assesses Corrective and Preventive Action Reports Participates in Regulatory Inspections Other duties as assigned Performs all job duties and ... biologic facility regulated by the FDA, EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and… more
- Merck & Co. (Durham, NC)
- …related to plant maintenance and spare parts procurement systems.Working knowledge of regulatory requirements in accordance with GMPsAbility to work in a highly ... effective team environment.Strong communication (written/verbal) skills.Ability to manage multiple priorities, strong planning, scheduling, and time management skills.Ability to work with and troubleshoot computer control equipment including Programmable Logic… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …performing and reporting internal and vendor audits as scheduled Participate in Regulatory Inspections Performs all job duties and responsibilities in a compliant ... and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others Other duties as assigned Physical Requirements While… more
