- Merck & Co. (Upper Gwynedd, PA)
- …At least five (5) years of relevant experience, including biological/pharmaceutical research ; manufacturing, testing, or regulatory CMC; or related fields.-The ... Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance… more
- Merck & Co. (Rahway, NJ)
- …tactical/scientific mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) ... attendance is required for, field-based positions; facility-based, manufacturing-based, or research -based positions where the work to be performed is located… more
- Merck & Co. (North Wales, PA)
- …any study specific partners and/or vendors.Core Skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple ... attendance is required for, field-based positions; facility-based, manufacturing-based, or research -based positions where the work to be performed is located… more
- Merck & Co. (North Wales, PA)
- …and key strategic engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to ... attendance is required for, field-based positions; facility-based, manufacturing-based, or research -based positions where the work to be performed is located… more
- Merck & Co. (Rahway, NJ)
- …mentorship to other clinical scientists.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. Job Summary: Manage… more
- Merck & Co. (Rahway, NJ)
- …Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be… more
- Merck & Co. (North Wales, PA)
- …senior management approval of evidence generation plans. Provides outcomes research leadership on cross-functional regional and global teamsCritically assesses ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programsIn… more
- Merck & Co. (Rahway, NJ)
- …ActivitiesParticipates in value evidence teams and serves as outcomes research representative on cross-functional regional and global teamsCritically assesses ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration… more
- Merck & Co. (North Wales, PA)
- …of an Executive Director, within the Value and Implementation, Outcomes Research the incumbent has the following responsibilities:1.) development of the integrated ... vaccines on a worldwide basis and 3.) development and implementation of Outcomes Research (OR) and Real World evidence programs to meet the value evidence needs… more
- Merck & Co. (North Wales, PA)
- …DescriptionRole SummaryThe Principal Scientist/Director, Value & Implementation (V&I) Outcomes Research , position resides in the V&I organization, which includes ... Global Medical and Scientific Affairs as well as Outcomes Research , and will support Pneumococcal Vaccines.Under the guidance of a senior leader, this position… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... Affairs and Clinical Safety (GRACS) function of Our Company's Research Laboratories ( Research & Development) by:Developing an active engagement strategy with US… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- OverviewA Research Assistant I position is currently available in Dr. Vakhtin's laboratory at The Mind Research Network. The Research Assistant will work on ... curation, as well as 3) careful development of and adherence to study regulatory and safety procedures. These responsibilities involve working in the MRI environment… 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
- Aequor (South San Francisco, CA)
- …scientific results that support the generation of publications, patents, or regulatory submissions and mentoring research associates and laboratory assistants. ... The candidate will independently devise and implement creative scientific research through conducting laboratory experiments, planning detailed procedures for… 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 position manages ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… 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: Responsibility for ... regulatory strategy to support the development of biomarkers, companion...products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan… more
- Eisai, Inc (Nutley, NJ)
- … regulatory aspects of Eisai's products under development and post approval research , including the development of regulatory strategies to ensure effective ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the… more
- Merck & Co. (Rahway, NJ)
- …efficient and effective use of funds.Engage with external partners, including regulatory bodies, industry associations, and research institutions, to advance ... execution of the strategic plan for the companion animal vaccine portfolio.Oversee the research and development of new vaccines, ensuring they meet regulatory … 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 disordersJob Summary: The ... Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi… more
