- 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
- Merck & Co. (Rahway, NJ)
- …aligned with our high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract ... customers and patients on time, every time, across the globe.Summary, Focus and PurposeThe Director of GMP Compliance will report to the head of the Global Quality… more
- Merck & Co. (Rahway, NJ)
- …and drive product robustness for sustained launch in alignment with the company's business goals, and quality and regulatory compliance. Essential Duties and ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role...receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to early… 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 ... drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong,… more
- Merck & Co. (Rahway, NJ)
- …- Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various ... build QMS capabilities that touch every aspect of our business processes, systems, and data.The Associate Director ...participating in supplier audits, and addressing any quality and regulatory issues.- This role aims to ensure compliance with… 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)
- …the guidance of a senior leader, a Senior Principal Scientist/Senior Director , has primary responsibility for developing value evidence strategies, and ... reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programsIn… 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)
- …concepts, practices, principles and sampling techniques and instrumentationIH regulatory requirements, industry consensus standards, and recognized best practicesAir ... independent and able to foresee issues and needs of the organization. Business acumen.Capability to make rapid and disciplined decisions and to prioritize… 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)
- …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)
- 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)
- …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)
- …help people around the globe. We are currently recruiting for Associate Director , US MarketingThe role will oversee foundational strategy and planning, including ... drive and align on decisions, including field sales, marketing operations, Legal, Regulatory , Medical, etc.Our US marketing team has adopted an Agile operating model… more
- Merck & Co. (Rahway, NJ)
- …produce safe, effective, innovative medicine.The Senior Principal Scientist/Senior Director is responsible for protocol development and medical/scientific oversight ... of manuscripts for publication in peer-reviewed journals. The Senior Director will also contribute to establishing Vaccine Clinical Development Strategies… more
- Merck & Co. (Rahway, NJ)
- …oral, sterile and combination products. You will also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities will ... lifecycle, as well as responding to agency questions.-Scientific Excellence and Regulatory Influence:Promoting our company's scientific excellence and regulatory … more
