- Eisai, Inc (Nutley, NJ)
- …industry preferred.Skills:Eisai Salary Transparency Language:The base salary range for the Executive Director , Global Regulatory Affairs - Neurology is from ... want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and... Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the ... International). Eisai Salary Transparency Language:The base salary range for the Associate Director , Global Medical Affairs Training and Education is from… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the Oncology at Eisai. This Executive ... opinion leaders, advisors as well as US and EU regulatory bodies in order to conduct Phase I, Phase...budget planning & resource management.Demonstrated track record as Study Director (or equivalent role) with Global Clinical… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Director , HCP Marketing, Alzheimer's Disease will lead several core marketing, strategy, and lifecycle ... and advise on opportunities for evolution and differentiation.Collaborate with our Global Marketing, Clinical Development, and Government Affairs on the go-to-market… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution ... focus of these plans and activities will be either global , US-focused with intended use and adaptation by other...budget and website portal as needed. Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance position is ... and internal process audits Facilitate Sponsor health authority inspections of global clinical facilities and study sites Continuously drive innovation through… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partner side) CDx RA Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these ... procedures.Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization… more
- Merck & Co. (Rahway, NJ)
- …and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation ... Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is… more
- Formation Bio (New York, NY)
- …clinical, and commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a ... sites. Regulatory Compliance & Submissions Ensure all CMC activities comply with global regulatory expectations (eg, FDA, EMA, ICH); author and review … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole Summary Under the guidance of an Executive Director , has primary responsibility for developing value evidence strategies, and planning/managing ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions.… 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 ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions. The… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization. ... with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support … more
- Merck & Co. (Rahway, NJ)
- …execution, reporting and interpretation of data. Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend ... West Point, PA / Rahway, NJ is seeking a curious and collaborative Associate Director to support our robust infectious disease and vaccines pipeline. - As an… more
- Merck & Co. (Rahway, NJ)
- …Divisional and Regional Quality/Management councilsProvide guidance and consultation services for regulatory reporting (eg, BPDR, DPR)Author and/or review global ... Job DescriptionThe Quality Assurance Director will provide compliance leadership and direction to...implementation and effectiveness to ensure no recurrence of findingsGather regulatory intelligence and partner with our Company and CMO… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Merck & Co. (Rahway, NJ)
- …other pharmacometric analyses- Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... PKPD Modeling, Population Pharmacokinetics, R-Studio, TeamworkPreferred Skills:Drug Discovery Process, Global Regulatory , Machine Learning, Multidisciplinary Collaboration, Multiple… more
- Merck & Co. (Rahway, NJ)
- …day-to-day coaching/guidance to individual contributorsMaintaining a comprehensive understanding of global regulatory expectations for small molecules and ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Merck & Co. (Rahway, NJ)
- Job 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...reimbursement and market access, and provides input into clinical, regulatory , payer/access, marketing and evidence generation strategies and programs.In… more
- Merck & Co. (Rahway, NJ)
- …long-standing or significant issues affecting quality and efficiency.Interprets complex regulatory requirements for various audiences, reviews draft policies and ... Audit Management, Business, Chemical Biology, Compliance Investigations, Deviation Management, Global Program Development, Good Manufacturing Practices (GMP), Management Process,… more
- Merck & Co. (Rahway, NJ)
- …- Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing ... Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for… more
