- Merck & Co. (Rahway, NJ)
- …intellectually curious, join us-and start making your impact today.-Overview: The Regulatory Planning and Publishing (RPP) Organization within Global Regulatory ... Process and Systems-(GRACS-OPS) is responsible for the execution of regulatory strategy to get and keep products on the...Transition Opportunities: -This Fellowship will be geared towards a-Sr Specialist -position and does not align to a full… more
- Merck & Co. (North Wales, PA)
- …curious, join us-and start making your impact today. -Overview: The Regulatory Digital Health (RDH) department engages with enterprise leaders across the ... support OPS (Operations, Processes, and Strategic Execution) Policy Execution and the regulatory strategy of digital health tools (DHTs) and software medical devices… more
- Merck & Co. (North Wales, PA)
- Job Description Position Description: Senior Specialist , Project Management- Drug Development The Senior Specialist , Project Manager is a core member of Early ... 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. (Rahway, NJ)
- …dedicated colleagues while developing and expanding your career.The Senior Trial Initiation Specialist in Global Site Budgets and Payments will be responsible for ... and presentation skills.Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines which includes knowledge of Standard of Care/Routine Care and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Specialist Reporting to the Director, the Senior Specialist Treasury Benefits Finance is responsible for providing ... and compliant funding of over $1 billion of employee benefits spend;Support regulatory reports for the Securities and Exchange Commission, Internal Revenue Service,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QC Specialist , Equipment Management as part of the Quality team based in Raritan, NJ. ... Role Overview The QC Specialist , Equipment Management is responsible for equipment lifecycle management and Quality Control (QC) systems administration. Key… more
- Aequor (Thousand Oaks, CA)
- …functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory , Quality Assurance, Quality Engineering, International Quality and Process ... Development on projects, issue resolution and investigations. The Specialist Stability builds and monitors stability studies within quality systems (eg LIMS), owns… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary: The Specialist , QA - Systems will be responsible for managing deviations, CAPAs, and/or managing change controls in the Veeva Digital system. The ... Quality Systems specialist will support... will support GMP activities to ensure compliance with regulatory and company requirements. Job Responsibilities:Assist with building and… more
- Merck & Co. (Durham, NC)
- …and requalification activities for multiple pieces of equipment. The Senior Specialist will primarily support vaccine drug manufacturing via Validation program ... Component SuppliersAuthor, review, and/or edit validation documents to support regulatory filingsSupport Change Control documentation for complex process, validation,… more
- Merck & Co. (Durham, NC)
- …currently Durham employs 1,000+ people. This role as an Operations Associate 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 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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …treatment of multiple myeloma. Legend Biotech is seeking a Master Data Governance Sr. Specialist as part of the Technical Operations team based in Raritan, NJ. Role ... Overview We are actively seeking a proficient Master Data Governance Sr. Specialist with a specific focus on Materials orchestration throughout the End-to-End… more
- Merck & Co. (Rahway, NJ)
- …job that provides both technical and project management responsibility. The Associate Specialist - Engineering Auto Eng position will report to the Director, ... developed through education or experience.Preferred:A working knowledge of the regulatory requirements for pharmaceutical applications.Programming skills in PLCs or… more
- Legend Biotech USA, Inc. (Baltimore, MD)
- …the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Cell Therapy Account Specialist - Washington, DC as part of the Commercial team that will be based ... Remotely. Role Overview The Sr. Cell Therapy Account Specialist is responsible for representing Legend's products and services to a defined customer base, generating… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics --Immune/Oncology-(QP2-IO)-team in the role of-Senior Specialist .--QP2-IO team is part of the Global Clinical Development ... senior scientists you will develop a comprehensive understanding of global regulatory expectations for small molecules and biologics, including support and authoring… 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
- 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
- BioAgilytix (Durham, NC)
- …therapeutics to the patients who need them.The Senior Laboratory Automation Specialist will be primarily responsible for leading the programming and implementation ... liquid handlers, robotic arms, and automated assay platforms.Familiarity with regulatory requirements for laboratory operations, including GLP and GMP.Exceptional… 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
