- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global ... Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible...Excellence & Analytics function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Experience with Computerized Maintenance/Metrology Management System (CMMS) systems (Blue Mountain Regulatory Asset Manager (RAM), SAP, or similar) preferred ... Lebanon, NH bioproduction facility. Relationships Reports to: Facilities and Maintenance Manager . Essential Functions Serves system administrator for the CMMS system… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …in accordance with Standard Operating Procedures Maintain documentation and ( Regulatory Asset Manager /RAM) database pertaining to calibration activities ... Completes required documentation in a manner compliant with all regulatory standards Assist plant personnel with troubleshooting and repair of production,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is seeking a Commissioning and Qualification Project Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewThis position ... systems within cell therapy manufacturing. The Commissioning and Qualification Project Manager will develop and manage all aspects of the qualification program… more
- Genmab (NJ)
- …integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our science through compelling clinical ... and regulatory documents. You'll be at the heart of a...of high-quality clinical documents to support operational, medical, and regulatory activities across the Genmab portfolio. You will help… more
- Eisai, Inc (NJ)
- …difference. If this is your profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with RandD IT to implement and maintain Eisai's ... TMF vision and transformation initiative and is compliant with ICH-GCP and regulatory requirements. This role also provides direction, leadership and training on the… more
- Genmab (NJ)
- …protocol deviations and is a key driver for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead ... Clinical Operations, Medical, Biomarker Management, Biostatistics, Medical Writing, and Regulatory Affairs to ensure alignment of data strategy with protocol… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring integrity, consistency and adherence ... programming efforts of at least one study are in scope.The Programming Manager will support the Data Management, Statistics, Drug Safety, Medical, Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Manager of HCP Marketing will be a pivotal driver in shaping an insights-driven HCP ... market access and public affairs (MAPA), Centers of Excellence (COEs), regulatory affairs, other relevant NNI departments, and external stakeholders to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …implications and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Collaborate With Downstream Account ... implications and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Identifies and prioritizes business… more
- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management Systems (QMS). Title commensurate with ... not limited to: investigative processes, CAPAs and CPIs, etc.Participates in regulatory agency inspections and customer audits, as needed; Performs and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation ... TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses and help submission team in quick turnaround in… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!Overview: The Programming Manager supports the development of new therapies by ensuring integrity, consistency and ... study or leading tasks within a study are in scope. The Programming Manager will work with other functions including Data Management, Statistics, Drug Safety,… more
- Merck & Co. (Boston, MA)
- …more productive and enable innovation.We are seeking a motivated and talented Product Manager to join the RaDS Product organization. The position will report to ... cross-functional experts as necessary to facilitate progress.Actively participate in regulatory audits and inspections in close collaboration with business… more
- Aequor (South San Francisco, CA)
- …the office (49% Homeoffice allowed) Job title Global Clinical Materials Manager Department PTDS-Global Competency Center Production Enablement Reports to Head Global ... while optimizing cost/quality. Within Production Enablement, the Global Clinical Materials Manager (GCMM) leads the coordination and execution of all procurement… more
- Aequor (Swiftwater, MN)
- …to Laboratory equipment - Ensure that the LIMS complies with all relevant regulatory standards - Support the business in the creation and updating of training ... system occur - Ensure that the LIMS complies with all relevant regulatory standards Technical competencies and soft skills: Working knowledge of aseptic processes,… more
- Lundbeck (Oakbrook, KY)
- …the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand creation ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations… more
- Lundbeck (Fort Wayne, IN)
- …transform lives. Join us on our journey of growth!As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
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