- Merck & Co. (Upper Gwynedd, PA)
- …in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and Assist the Executive Director /AVP in ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will...of Action and Milestones (POA&M), Regulatory Affairs Compliance , Regulatory Compliance {+ 5… more
- Merck & Co. (Boston, MA)
- …monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and ... in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director and/or… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations ... operational and overall delivery and tactical execution of the clinical studies. The senior director will ensure...review of regional / global policies and procedures. Ensure compliance with all Company and Regulatory requirements.Work… more
- Merck & Co. (South San Francisco, CA)
- …Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and ophthalmology pipelines. - As ... an Associate Director , you will represent QP2 on cr o ss-...sci e ntis ts to discover and advance the clinical development of novel therapeutic agents for cardiometabolic and… more
- Eisai, Inc (Nutley, NJ)
- …and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance ... for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs),… more
- Insmed Incorporated (San Diego, CA)
- … Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene ... Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Sr. Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with… 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 ... leader to drive pipeline impact and lead a talented group of pharmacometricians.This director will be part of a leadership team responsible for applying traditional… more
- Merck & Co. (Rahway, NJ)
- …applicable laboratory testing regulations.Experience ensuring compliance of a clinical laboratory with regulatory standards.Experience with the development ... clinical implementation and advancing digital pathology within our company's clinical therapeutic pipeline.The Principal Scientist ( Director ) will have the… more
- Merck & Co. (North Wales, PA)
- … Site Management, Clinical Testing, Clinical Trial Compliance , Communication, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, ... Affairs, Pharmacovigilance, Process Improvements, Project Leadership, Project Management, Regulatory Affairs Management, Regulatory Compliance {+… more
- Merck & Co. (Rahway, NJ)
- …identify growth opportunities and drive innovation.In-depth expertise in local regulatory frameworks, ethical standards, and pharmaceutical compliance ... Job DescriptionThe Executive Director (ED) for US Medical Affairs (USMA) understands...and scientific field medical capabilities in alignment with Global Clinical Trial Operations (GCTO) and the broader Global … more
- Merck & Co. (Rahway, NJ)
- …operations and/or large facility builds or renovations.A thorough understanding of regulatory / compliance expectations across all phases of product development ... The incumbent will support GMP capability build for the production of clinical supplies of bulk biologic drug substance at a state-of-the-art Next Generation… more
- Merck & Co. (Durham, NC)
- …Interpersonal Relationships, Lean Manufacturing, Management Process, Manufacturing Scale-Up, Regulatory Compliance , Root Cause Analysis (RCA), Strategic ... is seeking a highly motivated individual for the role of Assoc. Director , Engineering.- This role will provide end-to-end support of manufacturing science and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management processes across the global safety organization. The incumbent will ensure regulatory compliance , promote best practices, foster a culture of ... activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and… more
- Merck & Co. (Upper Gwynedd, PA)
- …through information science. We are seeking a passionate, experienced Associate Director to connect scientists and stakeholders with focused scientific literature ... knowledge services that empower research teams across the organization.As Associate Director , you will collaborate closely with cross-functional teams to design and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.- Ensures inspection readiness of all ... data review and cleaning, database lock), to ensure data quality/integrity and regulatory compliance - Ensures that Data Management Plans are consistent and… more
- Merck & Co. (Upper Gwynedd, PA)
- Job DescriptionThe Associate Director within Metrics, Analytics & Performance (MAP) has experience in clinical operations and is responsible for leading the ... modeling, and visualizations in support of user needs across Global Clinical Trial Operations (GCTO).Primary responsibilities include but are not limited to:Leading… more
- Merck & Co. (Rahway, NJ)
- …analysis, regulatory reporting, and publication.Specifically, the Senior Director may be responsible for:Evaluating pre- clinical and translational ... Research, Pulmonary Disease Treatment, Pulmonary Disorders, Pulmonology, Regulatory Affairs Compliance , Regulatory Compliance , Scientific Consulting {+ 1… more
- Merck & Co. (Rahway, NJ)
- …Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance , Regulatory Compliance , Scientific Leadership, Scientific ... clinical to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development, including study… more
