- 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)
- …high-volume clinical and commercial assembly equipment and processes for medical devices/ drug delivery systems. Reporting to the Director responsible for this area, ... and process development using semi-automated and automated equipment, conduct functional testing , assist in clinical batch manufacture as an equipment subject matter… more
- Merck & Co. (Rahway, NJ)
- …, Clinical Trial Development, Data Analysis, Decision Making, Drug Development, Intellectual Curiosity, Interdisciplinary Problem Solving, Mentorship, Neuroanatomy, ... Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and CDx submission plan for each country/region, both before and after CDx testing , for less complex projects.At the time of implementation of a CDx study/IVDR ... performance evaluation study integration of an assay into clinical testing (before testing ) and once data is...(Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into… more
- Aequor (Pearl River, LA)
- …procedures and within safety guidelines in the production of Flublok Drug Substance in the downstream processing (Clarification and Purification) and buffer ... for area equipment, including biosafety cabinets, magnetic mixers, in-process testing equipment (pH / conductivity meters and turbidity meters). Secondary… more
- Insmed Incorporated (San Diego, CA)
- …Development Operations function to build out the process development support testing function within analytical development. Will develop systems and processes to ... facilitate rapid, high throughput testing . As the Sending Unit, will facilitate transfer of...act as a program lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director… more
- Merck & Co. (Rahway, NJ)
- …and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and ... late stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide… more
- Merck & Co. (Rahway, NJ)
- …at a project level; ability to collaborate with key stakeholdersPosition Specific Required Skills and Experience: US and/or worldwide drug or vaccine ... data standard deliverables for world-wide regulatory application submissions of drug and vaccine clinical development projects. Accountability predominantly includes… more
- Merck & Co. (North Wales, PA)
- …presentation skillsEducation/ExperienceBachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience ... OR Master's Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree in life sciences,… more
- Merck & Co. (Rahway, NJ)
- …of generating early clinical development plan and Investigational New Drug applicationsDeveloping of clinical development strategies for investigational or marketed ... to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint… more
- Merck & Co. (Rahway, NJ)
- …Flexible Work Arrangements:Not ApplicableShift:Valid Driving License:Hazardous Material(s): Required Skills:Adaptability, Adaptability, Analytical Testing , ... (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply… more
- Merck & Co. (North Wales, PA)
- …statistical programming activities for multiple and/or late stage drug /vaccine clinical development projects. -Accountability predominantly includes the development ... years SAS programming experience in a clinical trial environment. Department Required Skills and Experience: Excellent interpersonal skills and ability to negotiate… more
- Merck & Co. (Rahway, NJ)
- …- Education/Experience Bachelor's Degree +5 years of pharmaceutical , clinical drug development, project management , and/or medical field experience OR Master ... ' s Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree Degree in life sciences,… more
- Merck & Co. (North Wales, PA)
- …etc.)Education/Experience: Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience/ Master's ... degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience or PhD/PharmD DegreeDegree in life sciences,… more
- Merck & Co. (Rahway, NJ)
- …establish a consolidated , visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).- - Responsible for authoring clinical supply ... Participate in Interactive Voice Response (IVR) System d evelopment and User Acceptance Testing (UAT) for assigned studies . - Mentors new team members and supports… 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 ... including supporting development of communication resources.To generate value evidence required by HTA/payers globally including value dossiers, evidence synthesis,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and troubleshooting ability to drive effective and robust production, testing and release of product to patients.Key Responsibilities Diagnoses, troubleshoot, ... knowledge of and compliance to all applicable codes and regulations as required . Obtains and keeps current all required licensing and certifications… more
- Merck & Co. (North Wales, PA)
- …as needed. More specifically,-Develops, coordinates, and provides biostatistical support for drug projects under the supervision of management.-Lead a team of staff ... of clinical trials; Experience with regulatory filing for approval of drug /vaccine products; Prior experiences with immunology clinical trials design, analysis and… more
- Washington VA Medical Center (Columbia, MD)
- …English. May require pre-employment evaluation which includes lab draw. Designated and/or random drug testing may be required -Federal jobs are covered under ... Drug Free workplace pursuant to Executive Order 12564; Reasonable suspicion testing is authorized in non- drug testing designated positions; All… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and collaboration across relevant cross functional groups to ensure robust production, testing and release of product to patients.Serve as the delegate for the ... organization.RequirementsBachelor's degree in Engineering, Life Sciences, or related field ( required ).Advanced degree (MS, MBA, or PhD) preferred.Minimally 12+ years… more
