- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical ... members to develop additional quality and auditing resources.Manage quality documentation in Veeva. (SOPs, CAPAs, Deviations, etc.)Position Requirements (Required… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Business System Labeling Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory ... Affairs Operations with Labeling Process and/or Digital Enablement experience strongly preferred, and experience with IT System/Business System Management.Education… more
- Merck & Co. (Durham, NC)
- …a wide range of business activities.- Reporting directly to the Director , Supply Chain Management, the successful candidate's primary responsibilities will include ... Data team with general Material Handling Steward tasksDrive safety, quality and process enhancements throughout the supply chain - Project Management Lead and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJoin Our Team as an Associate Principal Scientist/Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant ... and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, and technology transfer of biopharmaceutical drug… more
- Merck & Co. (Upper Gwynedd, PA)
- …Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.Lead the… more
- Merck & Co. (Rahway, NJ)
- …The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical development, ... requested by Product Development Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the Oncology at Eisai. This Executive ... Director will lead franchise programs, and will be the...Phase II and Phase III studies, and prepare related documentation for submissions.This position will lead a development team… more
- Eisai, Inc (Exton, PA)
- …If this is your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a ... technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing scientific leadership… more
- Twist BioScience (South San Francisco, CA)
- Sr. Director , Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated Manufacturing ... Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, in-house developed MES solutions across our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project. This position prepares trainings, supports CAPA investigations, case review, documentation reviews in collaboration with the ICSR management and CRO/Vendor ... oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Director , Market Intelligence and Portfolio Insights will leverage Competitive Intelligence methodologies ... a high-performing team while ensuring compliance with legal standards. The Director will drive informed decision-making and strategic alignment through actionable… more
- Insmed Incorporated (Los Angeles, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director Medical Science Liaison will develop and maintain professional ... assigned budget parametersIs accountable for the accurate and timely documentation of all activitiesIdentify Medical Experts, consultants, investigators, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and they understand their level of accountability for results and the measurement process . Ensure that the IDP forms include completed learning and aspiration plans ... Effective in fast-paced environments with a focus on quality and documentation Skilled in change management and guiding teams through transitions Communication… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in fast-paced environments with a focus on quality and documentation .Skilled in change management and guiding teams through transitions.Excellent communication ... analytics to senior stakeholders.Creative problem-solver with a track record of process improvement.The base compensation range for this position is $ 181,670… more
- Repligen (Hopkinton, IA)
- …pm EST.The Document Control/QA Associate I will report directly to the QA/QC Director .This position is responsible to actively participate in the Repligen ISO 9001 ... role is responsible for assisting the document control department in processing documentation requests. They will work closely with cross-functional teams and within… more
- Merck & Co. (Rahway, NJ)
- …in independently conducting and directing the planning, execution, analysis, and documentation of all stages of cell culture process commercialization.Experience ... (CPD), technology transfer (TT), scale-down model qualification (SDMQ) and process characterization (PC).Experience authoring technical documentation in support… more
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... and industrial standards of control strategy for residual HCPs and other process related impurities in biologics.A strong team player with excellent oral and… more
- Merck & Co. (Rahway, NJ)
- …team.Author protocols, reports, create drawings and specifications to ensure proper documentation of process development activities in accordance with relevant ... Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our...processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in… more
- L3Harris Technologies (Merritt Island, FL)
- …land, sea and cyber domains in the interest of national security. Job Title: Director , Global Networks Job Code: 25595 Job Location: Salt Lake City, UT or Melbourne, ... Springs, CO or Washington DC Job Schedule: 9/80 Job Description: The Director , Global Networks will lead growth, capture, and programmatic activities within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Markets Strategy, Market Access Leadership Teams, Marketing, HEOR, and the Associate Director of Market Access Insights to identify market and customer scenarios ... critical decisions. Relationships This role reports to the Associate Director , Market Access Insights, Diabetes. Works closely with Commercial Effectiveness,… more
