- Eisai, Inc (Nutley, NJ)
- …the development of regulatory strategies to ensure effective achievement of regulatory / business objectives. The Executive Director will direct the ... this is your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global … more
- Eisai, Inc (Nutley, NJ)
- …Skills, Communication & Cross-functional Influence, Critical Thinking & Business Agility, Industry/ Regulatory Knowledge, Mentoring/ People ... responsible for designing clinical trial, performing data analysis, supporting regulatory interactions, overseeing CRO activities, validating TLGs and analysis… more
- Eisai, Inc (New York, NY)
- …drive performance, engagement, and future growth of the team. Qualifications: Regional Business Director - ADBachelor's degree (Master's preferred) and 10+ years ... Eisai. Business need driven role requiring proven performance in earlier role.Sr. Regional Business Director - ADProven performance as a Regional Business … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving ... Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. The Executive Director will manage and oversee the entire cycle of late stage clinical… more
- Merck & Co. (Rahway, NJ)
- …development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director ... of new compounds, and the further study of marketed compounds.Support of business development assessments of external opportunitiesThe Senior Director May:… more
- Merck & Co. (Rahway, NJ)
- …inspection and audit CAPA, site internal audit programs, and GMP-related regulatory communications. Oversee program to ensure CRS support to sites before, ... health authority reporting program to ensure compliance to global regulatory reporting requirements (eg, Field Alert Reports (FARs), Biological Deviation… more
- Merck & Co. (Rahway, NJ)
- …with a passion for biologics? We're looking for a dynamic and visionary- Director , Drug Substance Leader-to drive innovation and excellence across our Biologics ... commercialization Provide technical oversight for DS process development, characterization, and regulatory filings Ensure smooth execution of PPQs and BLAs for… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... matter expertise, a strong understanding of drug commercialization and the regulatory landscape.In this role, the successful candidate will be responsible toManage… more
- Merck & Co. (Rahway, NJ)
- …motivated and experienced Anatomic Pathologist (MD) for the role of Principal Scientist ( Director ) to join our innovative team. This position will play a crucial ... pathology within our company's clinical therapeutic pipeline.The Principal Scientist ( Director ) will have the following responsibilities: Engage in providing… 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 ... at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate Director … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description Director -QP2-IO We are seeking an experienced talented scientist to join the - Quantitative Pharmacology and Pharmacometrics - - ... Immune/Oncology - (QP2-IO) - team in the role of Director . QP2-IO team is part of the Global Clinical...and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology,… more
- Merck & Co. (Rahway, NJ)
- …strategic and tactical technical direction through cross-functional partnerships with key business units and customers. Your leadership will be instrumental in ... oversight of DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful… more
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and ... development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams of highly… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAbout the Role:-As a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a ... External Partners. Foster proactive partnerships with External Partners to meet business goals, identify and mitigate risks, and continuously enhance performance.… more
- Merck & Co. (Rahway, NJ)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for ... all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong … more
- Merck & Co. (Rahway, NJ)
- …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-...vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug… more
- Merck & Co. (Rahway, NJ)
- …the guidance of a senior leader, an Associate Principal Scientist/Associate Director , has primary responsibility for planning/managing real world and economic ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Merck & Co. (Rahway, NJ)
- …between clinical development teams and the operational/executional arms within the business . The Program Clinical Supplies Project Manager (Program CSPM) serves as ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,- strategies… more
- Merck & Co. (Rahway, NJ)
- …Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Director , Quantitative Systems Pharmacology (QSP) . QP2-IO team is part of the ... of the strategic elements of drug development. As a subject matter expert, the Director within the QP2-IO Group will work closely with teams of highly collaborative,… more
