- Merck & Co. (Rahway, NJ)
- …& Technology (DD&T) organization designs, develops, and commercializes novel biologic/ drug / vaccine - device enabled combination products to achieve safe and ... set direction for the device development strategy for multiple drug -device combination product development programs ranging from concept generation/selection,… more
- Merck & Co. (Rahway, NJ)
- …to high-volume clinical and commercial assembly equipment and processes for medical devices/ drug delivery systems . Reporting to the Director responsible for this ... develop robust assembly specifications with sound justification.Understand medical device/delivery system product design, functionality, storage, and handling requirements to… more
- Merck & Co. (North Wales, PA)
- …that include coordinating the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership ... supports statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the development… more
- Merck & Co. (North Wales, PA)
- …processes (SOPs) and software development life-cycle (SDLC) US and/or worldwide drug or vaccine regulatory application submission experience including the ... : This position supports statistical programming activities for late stage drug /vaccine clinical development projects. This may include leadership of one or… more
- Merck & Co. (Rahway, NJ)
- …and Validation plans around equipment, critical utilities, and computer systems .- Prepare and approve qualification protocols and summary reports.- Execute ... Prepare Validation plans and annual reports around critical equipment and systems .- Maintain GMP documentation where applicable, such as GMP engineering drawings… more
- Lundbeck (Bothell, WA)
- …of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our ... chemicals, and consumables including ordering and receiving using Lundbeck procurement system Process biohazardous waste for pick-up Media and buffer preparation… more
- Genmab (NJ)
- …scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation ... and stratification plansPerform UAT of Randomization part of the IRT system as applicableEnsure procedures for blinding are in place as applicableSupport… more
- Merck & Co. (San Francisco, CA)
- …of DSCS Digital initiatives.Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and Clinical Supply ... solving complex problems. Experience in one or more of the areas of Drug Substance development, Drug Product development, Clinical Supply management or… more
- Merck & Co. (Rahway, NJ)
- …for management of third party manufactures of our Company's products across drug substance, drug product and packaging operations.- The organization helps ... compliance with the Supply AgreementPartners with the ExM Company Production System experts and other functionalities supporting ExM (eg technical, quality,… more
- Merck & Co. (Rahway, NJ)
- …Development & Technology (DD&T) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and ... MINIMUM REQUIREMENTS: BA/BS in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering,- or other types of engineering plus 10 years of… more
- Merck & Co. (North Wales, PA)
- …deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator-meeting planning, communication plans, preparation of ... Outlook, etc.)Education/Experience: Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience/ Master's… more
- Merck & Co. (Rahway, NJ)
- …Our Team as an Associate Principal Scientist/Associate Director in Biologics Drug Substance Commercialization!Are you ready to make a significant impact in ... forefront of innovation in the-Manufacturing Division, specifically within the-Biologics Drug Substance Commercialization (BDSC) team. Our Downstream Purification-department is… more
- Insmed Incorporated (San Diego, CA)
- …process development support testing function within analytical development. Will develop systems and processes to facilitate rapid, high throughput testing. As the ... Development Team representative as an Analytical Lead for a drug program.Key Responsibilities:Responsibilities include developing and optimizing analytical methods… more
- Merck & Co. (North Wales, PA)
- …will support one or more assets, including but not limited to antibody drug conjugate assets for cancer treatment.To support the implementation of RWE capability ... with scientific leaders, patient organizations, academic medical centers, health systems , research organizations, database holders, and others.To prepare outcomes… more
- Merck & Co. (North Wales, PA)
- …to meet the value evidence needs of payers, advisory committees health systems , and clinicians.The incumbent can generate these plans based on direct interactions ... evaluates health programs leveraging different parts of health care systems that can enhance value and use of products.Implements...need, patient reported outcomes (PRO) and the value of drug therapy as outlined in the OR planning process… more
- Merck & Co. (Rahway, NJ)
- …advice to stakeholders creating optimal development, commercialization, and drug /delivery device supply strategies-Building our leadership and functional capability ... with members of GRACS Leadership Team to provide guidance on the application of regulatory activities with cross- product or cross-functional impact, including … more
- Genmab (NJ)
- …scientific and technical progress within the field of biostatistics in drug development and advise of new methodologies that may support innovation ... randomization and stratification plans Perform UAT of Randomization part of the IRT system as applicable Ensure procedures for blinding are in place as applicable… more
- Novo Nordisk Inc. (Langhorne, PA)
- …field and home office personnel. Essential Functions Adhere to the Prescription Drug Marketing Act of 1987 and all related Novo Nordisk policies regarding ... data Monitor and reinforce the use of the Sales Force Automation System Communicate Regional activity of competitive products through timely submission of monthly… more
- Genmab (NJ)
- …labeling documents; Maintain and track labeling documents in the electronic system as appropriate.Participate in the development and maintenance of SOPs, work ... a multicultural/multinational environmentProficiency with MS-Office Suite and Adobe Acrobat application and ability to work in electronic document management… more
- Eisai, Inc (Nutley, NJ)
- …Director will direct the development and submission of investigational drug applications, product registration dossiers, supplements, amendments, as well as ... agencies. Experience in managing the preparation of a marketing application (NDA/BLA/MAA) in CTD format for a major market...Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in… more
