- 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
- Merck & Co. (Rahway, NJ)
- …cost estimates requested by Product Development Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities ... as well as supply chain documentation to support critical CMC activities. - - Support...- Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is highly desirable. - Preferred… more
- Merck & Co. (Rahway, NJ)
- …Drug Product and Clinical Finished Goods).- - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as ... well as supply chain documentation to support critical CMC activities . - Responsible...- Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is highly desirable. - Preferred… more
- 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)
- …Proven experience in running clinical studies with an understanding of Clinical Operations and Data Management preferred . Significant experience working with ... want to hear from you. The Executive Director, Global Clinical Development resides within the Oncology at Eisai. This...Phase II and Phase III studies, and prepare related documentation for submissions.This position will lead a development team… 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
- 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
- Merck & Co. (Rahway, NJ)
- …including analysis/modeling datasets, tables, listings, figures and associated documentation .Ensure programmatic traceability from data source to analysis/modeling ... Engineering or related field plus 3 years SAS programming experience in a clinical trial environment OR a Bachelor's degree in Computer Science, Statistics, Applied… 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
- 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
- Insmed Incorporated (Los Angeles, CA)
- …Medical Strategy, Clinical management/trial experience and 2 years clinical or research experience (non-pharma) is preferred .An excellent command ... assigned budget parametersIs accountable for the accurate and timely documentation of all activitiesIdentify Medical Experts, consultants, investigators, 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
- Merck & Co. (Rahway, NJ)
- …and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, and technology transfer of biopharmaceutical ... foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation , ensuring all processes align with our company's expectations.Mentor… more
- Merck & Co. (Rahway, NJ)
- …for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines.Authoring and reviewing internal technical reports, ... matrix management and peer to peer coaching.Accurately and efficiently documentation of experiments.Strong ability to deliver complex objectives under aggressive… 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 ... - Ensure facility readiness with respect to cleaning (including documentation and execution), batch execution, building housekeeping, and consumable inventory.… more
- Merck & Co. (Omaha, NE)
- …export country shipping metrics. The successful candidate will ensure that all documentation for the department has been completed accurately and will look at ... handle any export concernsWork with the markets to insure they have all of the documentation necessary to clear customs - Work with the plants to ensure the due… more
- Merck & Co. (Rahway, NJ)
- …To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... and scalable upstream processes for biologics in different stages of clinical development, 2) process characterization and regulatory filings for successful… more
- Aequor (Thousand Oaks, CA)
- …Project Planning, an activity that is vital to the impact that ATO B20 with a clinical and commercial product mix has to the network. This role will function as a ... supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.… more
- Merck & Co. (Durham, NC)
- …with Microsoft Office (Excel, Word, PowerPoint)Excellent planning, organizational, documentation , presentation and communication skillsAbility to work in ... focuses on guiding, training and developing personnel to their fullest potential. Preferred experience and skills: Master's degree in science / engineering /… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP) preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. ... project. This position prepares trainings, supports CAPA investigations, case review, documentation reviews in collaboration with the ICSR management and CRO/Vendor… more
