- Insmed Incorporated (San Diego, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... patients. That's why we've been named the No. 1 company to work for in the biopharma industry in...Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical … 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 ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...signal for sourcing, manufacturing, packaging, and distribution- for our company development products and non-our company marketed… more
- Merck & Co. (Rahway, NJ)
- … Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full Company 's Research & Development ... by Product Development Teams . - Responsible for authoring clinical supply documentation in support of labeling...Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can… more
- Merck & Co. (North Wales, PA)
- …Material(s):Required Skills:Business Development, Business Development, Business Management, Clinical Documentation , Clinical Investigations, ... as a senior therapeutic area content expert within the company , providing input into research and business development priorities... Clinical Judgment, Clinical Reporting, Clinical Research, Clinical Trial Documentation ,… more
- Eisai, Inc (Nutley, NJ)
- …caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... 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
- 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
- Merck & Co. (Rahway, NJ)
- …center, primarily for sterile operations under the remit of Our Company 's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering ... Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS)The FLEx sterile facility supports the formulation and filling… 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
- Eisai, Inc (Exton, PA)
- …to III studies), and in the late-stage processes at CMOs that support the company 's clinical development pipeline. The individual contributes to the success of ... caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong… 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...EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented,… 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
- 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
- Merck & Co. (Omaha, NE)
- …letters of credit.- Work with and handle all of the countries that our Company Animal Health (AH) Division supports and will use the most efficient freight forwarder ... export country shipping metrics. The successful candidate will ensure that all documentation for the department has been completed accurately and will look at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas of potential non-compliance or operational risks.Responsibilities:Maintain regulatory procedural documentation , in line with company -wide policy and ... function, responsible for ensuring Daiichi Sankyo's Regulatory processes & procedural documentation are fit for purpose and compliant with relevant regulations. This… more
- Merck & Co. (Rahway, NJ)
- …to foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation , ensuring all processes align with our company 's ... make a significant impact in the world of biopharmaceuticals purification? At-Our Company , we are at the forefront of innovation in the-Manufacturing Division,… more
- Merck & Co. (Rahway, NJ)
- …medical breakthrough.The Biologics Analytical Research & Development department of our Company 's Research & Development Division is seeking applicants for a ... for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines.Authoring and reviewing internal technical reports,… more
- Formation Bio (New York, NY)
- About Formation BioFormation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech,… more
- Insmed Incorporated (Los Angeles, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are ... systems, and processes within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will… more
