- Merck & Co. (North Wales, PA)
- …mentorship to other clinical scientist.Core Skills Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage ... attendance is required for, field-based positions; facility-based, manufacturing-based, or research -based positions where the work to be performed is located… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …stakeholders within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs. Facilitate operational meetings with ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Leads the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Regulatory Affairs and Clinical Safety Global Process Lead is responsible for overseeing and managing Global Regulatory Affairs & ... standards, process maps, and risk management for global processes across Global Regulatory Affairs and Clinical Safety . The Global Process Lead actively engages… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We ... Clinical Development, has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs in the Oncology Clinical… more
- Merck & Co. (Rahway, NJ)
- …Scientist) has primary responsibility for the planning and directing clinical research activities within the Atherosclerosis and Metabolism therapeutic area, with a ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. - Specifically, the Senior Director may… more
- Merck & Co. (Rahway, NJ)
- …Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines. Our company's ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be… more
- Merck & Co. (Rahway, NJ)
- …milestones in global healthcare.The primary objective of the Small Molecule Analytical Research and Development (SMAR&D) team is to carry out R&D activities ... their stability tests, raw materials/excipients, and packaging components for our research pipeline.- This research opportunity contributes to the Development… more
- Merck & Co. (Rahway, NJ)
- …has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our company's oncology ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The Associate ... Director of Regulatory Writing is a key role responsible for producing...key role responsible for producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary This role offers ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The Associate ... Director, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and drives coordination of global and US regulatory activities. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in… more
- Merck & Co. (Rahway, NJ)
- …complementary areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control ... Job DescriptionOur Research Scientists are our Inventors. We identify and...strong network internally and across the external academic and regulatory community is expected, as well as advancing a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Summary This role will ... and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Responsible for ... leading and developing global regulatory strategy for assigned development... strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings.… more
- Merck & Co. (Rockville, MD)
- …Regulatory organizations;Leadership for strategy and coordination of our Research & Development Division External Policy relationships to meet priorities;Building ... the company on the development and implementation of clinical research policy goals.Working closely with the Global Regulatory... research policy goals.Working closely with the Global Regulatory Policy team to align on clinical research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This role is ... responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on assets which are subject to an Alliance. This role will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Effectively liaise, ... and partner with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support across all global projects,… more
- Merck & Co. (Lower Gwynedd, PA)
- …(AdVAnce) Vaccines bioanalytical group located at our Company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
