- Merck & Co. (North Wales, PA)
- Job DescriptionThe Data Standards Specialists is responsible for: Defining standard collection and mapping data definitions aligned with industry (CDISC) ... standards and Health Authority regulationsEnsuring the definitions are maintained...regulatory data management and reporting requirements.Strong knowledge of the Drug Discovery Process, ICH and GCP guidelinesKnowledge of Analysis… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... high quality deliverables are on time and within budget to support drug development processes and global submissions. This position also partners with internal… more
- Tris Pharma (Monmouth Junction, NJ)
- …Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.The ... SOPs, cGMP, FDA, as well as all applicable company compliance guidelines, standards and objectivesOversee and manage the maintenance and tracking of Quality Systems… more
- Insmed Incorporated (Bridgewater, NJ)
- …development, qualification/validation, transfer and characterization for drug substance, drug product and reference standards . The Manager must possess ... products, reference standard qualification and physical (solid-state) characterization of drug product and drug substance.Prepares and approves technical… more
- Advanced Recovery Systems (Columbus, OH)
- …substance abuse issues, addictions and mental health concerns.The Recovery Village Columbus Drug and Alcohol Rehab (RVC) is dedicated to connecting those struggling ... like yoga and art therapy promote mind and body healing.The Recovery Village Columbus Drug and Alcohol Rehab is a premier treatment facility in the picturesque town… more
- Merck & Co. (Rahway, NJ)
- …company is seeking leadership of our Biologics and Mixed Modalities Drug Product Development teams, responsible for the scientific and technical oversight ... of our small molecule, large molecule, and mixed modalities drug product formulation design, process development, and innovation to establish and maintain a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... design and leadership of clinical development plans, and addressing all regulatory, drug and patient safety, data, CMC, IP, patient selection, market acesss and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... and immune disorders. Summary Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently… more
- Insmed Incorporated (Westerville, OH)
- …values of PASSION, COLLABORATION, INTEGRITY, RESPECT and ACCOUNTABILITY to the highest standards . Additionally, we expect all employees to serve as Insmed cultural ... exceptional knowledge of: disease state, product, customer, orphan/rare and specialty drug market, competitive landscape and the broader healthcare market place.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... (Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into...robust development of assay, participate in HA interaction for drug -related CDx topics/questions, and attend device company HA meetings… more
- Merck & Co. (Rahway, NJ)
- …engage, collaborate, mentor, and inspire team members.Strong working knowledge of ISO standards such as 11608, 11040 performance tests and studies including break ... Expertise in testing, characterization, and troubleshooting of: Combination product drug delivery device components - plastic, metal, glass, elastomeric materials,… more
- Merck & Co. (Rahway, NJ)
- …to support the launch of a new generation of products, including antibody drug conjugates and peptides, will blur the boundaries between the traditional small ... labs. -Enable our research and manufacturing engineers and scientists to expedite drug process development and troubleshoot process problems.-- Ensure the success of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... group to develop and apply QSP models to aid in drug discovery/development decisions, which include target prioritization, therapeutic modality selection, biomarker… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... disorders. Summary This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... The primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
- Merck & Co. (Rahway, NJ)
- …programming activities for multiple and/or large/complex late stage drug /vaccine clinical development projects.- Accountability predominantly includes the ... process compliance, (2) effective deliverable development utilizing global and TA standards that optimize analysis and reporting and promote a strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and External Vendors for the data services they provide to support drug development processes and global submissions.This position provides expertise within Data ... data concepts, working knowledge of data collections (EDC & Non-EDC), industry standards (CDISC / SDTM), and technical skillsfor integrating and importing external… more
