- Merck & Co. (North Wales, PA)
- …Material(s):Required Skills:Business Development, Business Development, Business Management, Clinical Documentation , Clinical Investigations, ... Clinical Judgment, Clinical Reporting, Clinical Research, Clinical Trial Documentation , Clinical Trial Planning, Consultative Approach,… more
- Eisai, Inc (Nutley, NJ)
- …collating information and providing updates to the CRO Initiates, tracks and collates clinical trial documentation related to CSR appendices. Act as central ... clinical team for designated projects, communications, and associated documentation Document Creation and Management: Assist with creating, updating and… more
- Insmed Incorporated (San Diego, CA)
- …and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance ... compliance related to GCPs, acts as quality lead on the gene therapy clinical development team, and collaborates on other related activities performed by Clinical… more
- Eisai, Inc (Nutley, NJ)
- …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 clinical group leader for the ongoing and planned development...Phase II and Phase III studies, and prepare related documentation for submissions.This position will lead a development team… more
- Merck & Co. (Rahway, NJ)
- …Quality Operations - API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP) clinical supply API ... manufacture, testing, release, and maintenance in support of our company's clinical supply programs. This person will also independently review and approve … more
- Merck & Co. (Rahway, NJ)
- …Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The FLEx sterile facility supports the formulation and filling ... of clinical and developmental supplies for sterile products, including critical...developmental use.- Author, review and approve GMP procedures and documentation , with an emphasis on Qualification and Validation plans… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …activities- Oversee the quality and timeline of vendor work- Collaborate with study clinical or medical lead and biostats to ensure availability of necessary data- ... of authorship agreements, financial disclosures and author approvals- Ensure documentation of compliance with authorship and publication guidelines as stipulated… more
- Merck & Co. (Rahway, NJ)
- …& Development team that designs and develops benchtop/low-volume to high-volume clinical and commercial assembly equipment and processes for medical devices/drug ... using semi-automated and automated equipment, conduct functional testing, assist in clinical batch manufacture as an equipment subject matter expert, assist with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials and creation of regulatory submission documentation with the ... audits assigned. Support conduct of document audits including eTMF, Clinical Study Reports and Common Technical Document submission.ResponsibilitiesSupport audit… more
- Eisai, Inc (Exton, PA)
- …new products in development through their lifecycle (Preclinical through phase III clinical development) at the Biologics Pilot Plant as well as supporting ... pilot plant, including scheduling of staff, preparation and close-out of documentation , manufacture of DS/ADI materials, and suite change-over ensuring compliance to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This ... work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV, Clinical Operations, Clinical Development, RA CMC) to keep processes,… more
- Genmab (NJ)
- …join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early ... responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and… more
- Merck & Co. (Rahway, NJ)
- …including analysis/modeling datasets, tables, listings, figures and associated documentation .Ensure programmatic traceability from data source to analysis/modeling ... field plus 3 years SAS programming experience in a clinical trial environment OR a Bachelor's degree in Computer...field plus 5 years SAS programming experience in a clinical trial environment.Minimum requirement:Must have experience in CDISC SDTM… more
- Aequor (Athens, GA)
- …in accordance with study protocols, completes and maintains appropriate documentation associated with all job assignments, and provides equipment sanitation ... the direction of the Site Veterinarian or delegate. Conducts scientific clinical observations and disease outcome assessments. May administer experimental treatment… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Merck & Co. (Rahway, NJ)
- …achieve our goals, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a ... robust and scalable upstream processes for biologics in various stages of clinical development, as well as process characterization and regulatory filings for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will ... protocols, reports, risk assessments, technical studies, and any associated documentation in support of computer systems validation, equipment, utilities, and… more
- Insmed Incorporated (Los Angeles, CA)
- …assigned budget parametersIs accountable for the accurate and timely documentation of all activitiesIdentify Medical Experts, consultants, investigators, and ... a local medical and scientific resource to Insmed for product planning, clinical insights, and intelligence. Bring together, synthesize and deliver HCP derived… more
- Merck & Co. (Rahway, NJ)
- …aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of ... of the facility.Ensure facility readiness with respect to cleaning (including documentation and execution), dummy run and batch execution, building housekeeping, and… more
- Aequor (Athens, GA)
- …protocols, including cleanliness of assigned facilities and the completion of all documentation activities to comply with FDA/EU and Good [Laboratory, Clinical , ... Completes operational log paperwork, daily log files, and work order documentation with appropriate detail and accurate information utilizing a combination of… more
