- Formation Bio (New York, NY)
- …area, business strategies, and the company's goals. About You BS, BSc, MS, MSc, PhD , PharmD, JD, or MD in science or healthcare preferred or equivalent ... to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and directing the regional… more
- Legend Biotech USA, Inc. (Detroit, MI)
- …the franchise.Fully understand and apply MSL SOP's/guidelines and company HCC/ Regulatory /Legal guidelines.RequirementsAdvanced terminal degree (PharmD, PhD , MD, ... the treatment of multiple myeloma.Legend Biotech is seeking Medical Science Liaison as part of the Medical Affairs team...part of the US Medical Affairs team, the Medical Science Liaison (MSL) will be responsible for engaging identified… more
- Insmed Incorporated (San Diego, CA)
- …the future of science , we're in. Are you?About the Role:The Director, Regulatory Affairs will serve as the regulatory leader on cross-functional teams, where ... degree in scientific field. Advanced degree in a scientific or regulatory area (Master's/ PhD /PharmD) preferred. RAC certification desired10+ years of… more
- Insmed Incorporated (NJ)
- …contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as ... patients, for each other, and for the future of science , we're in. Are you?About the Role:This position is...Role:This position is a key role that will provide regulatory CMC (RA CMC) leadership and strategy to achieve… more
- Tris Pharma (Monmouth Junction, NJ)
- …products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.Our science and technology make us unique, ... will apply model-informed drug development (MIDD) principles to support translational science and clinical development plans from first-in-human through late phase… more
- Merck & Co. (Rahway, NJ)
- …combination products. PhD degree in Biomedical Engineering, Mechanical Engineering, Materials Science , or related disciplines, with a minimum of 15 years of ... Skills:Technical Knowledge:In-depth understanding of Autoinjector design, manufacturing processes, and regulatory requirements.Familiarity with materials science , particularly as… more
- Merck & Co. (Rahway, NJ)
- …point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the ... benchtop science of preclinical discovery into compounds ready for assessment in large clinical populations.We are seeking a highly qualified physician-scientist… more
- Merck & Co. (Rahway, NJ)
- …are not limited to: The Associate Principal Scientist is a DVM and/or PhD whose primary function is to design, coordinate, monitor, and report clinical laboratory ... and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires the candidate be responsible for… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-We are seeking a strategic and technical leader with ... Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and ... Affairs function. This role will leverage advanced analytics, data science methodologies and various medical data sources and real-world... or related field, required- Advanced degree - including PhD / PharmD, MD or related degree preferably in… more
- Merck & Co. (Rahway, NJ)
- …are our Inventors. Through innovative thinking, state-of-the-art facilities, cutting-edge science , and technology, we collaborate to deliver the next medical ... shape and drive innovation across the Biologics pipeline, strategy, and science .Anticipate and solve scientific and technical challenges across projects and… more
- Merck & Co. (Rahway, NJ)
- …Processes, Clinical Trials Analysis, Data Analysis, Data Management, Data Science , Numerical Analysis, Physiology, Regulatory Compliance, Regulatory ... design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/… more
- Merck & Co. (Rahway, NJ)
- …OR PhD in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years relevant ... development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership… more
- Merck & Co. (Rahway, NJ)
- …OR PhD in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years relevant ... development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership… more
- Insmed Incorporated (NJ)
- …contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as ... list in the UK.For patients, for each other, and for the future of science , we're in. Are you?About the Role:The Associate Director, Quality Control will be… more
- Eisai, Inc (Nutley, NJ)
- …to safety and efficacy.Contributes to Clinical Pharmacology expertise and content to regulatory documents (eg briefing books, INDs, NDAs etc.) and represent Clinical ... and deliverables to approve payment of invoices and resolve discrepancies. Requirements A PhD , MD or PharmD degree with at least 5 years of pharmaceutical industry… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go decisions on programsFoster… more
- Insmed Incorporated (NJ)
- … regulatory authorities.Who You Are:Master's degree required; PharmD or PhD strongly preferred.Minimum of 5 years clinical drug development experience.Strong ... contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four consecutive years, certification as… more
- Genmab (NJ)
- …the CSRAttend operational and steering committee meetings, as applicableSupport regulatory submission/filing activitiesRequirementsMS / PhD or equivalent in ... compassionate, candid, and purposeful, and our business is innovative and rooted in science . We believe that being proudly authentic and determined to be our best… more
- Takeda Pharmaceutical (Boston, MA)
- …clinical science activities involved in interactions with FDA, other regulatory agencies and key opinion leaders relevant to assigned compounds. Responsible for ... regional specificities within Therapeutic Area.ACCOUNTABILITIES: Accountable to Oncology Clinical Science Head to provide strategic clinical input on assigned… more
