- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you.Responsibilities:Actively participate in planning and execution of Market Access strategy and manage assigned marketing ... plans).Collaborate with cross-functional teams (eg, brand, HEOR, market research, sales, regulatory , legal, field market access teams) to develop aligned market… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Director is responsible for developing RWE strategies for assigned product(s) and execution of RWE ... and value to support medical development, additional (post approval) regulatory and safety needs.Ensure communication/publication strategies for given products and… more
- Eisai, Inc (Nutley, NJ)
- …communication/publication components of overall medical operating plan. The Medical Director provides strategic development, planning , implementation and ... If this is your profile, we want to hear from you.The Medical Director , US Medical Affairs provides medical leadership for medical affairs strategy, planning… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. Job Summary The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with key stakeholders to develop… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, ... regulatory , and compliance standards. Collaborating with business and EIT...Decisions for Eisai Americas IT Compliance and Security: investment planning , business outcomes, budgeting and systems related decisions.Directs priorities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.Summary The Director , Head of Global Dossier Planning , Regulatory Operations is responsible for leading the dossier planning ... major submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions...in all regions. The Director of Dossier Planning will report to Head of Global Regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Collaborates with external KOLs to refine study plans; Prepares and participate in regulatory agency meetings, if applicableStudy planning and execution: As CSL ... Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Functions. Candidate will establish internal and external benchmarks to inform future planning and target setting. Candidate will oversee the build and governance of ... GDO / GCO / BDM / RD Finance/ CSPV/ Regulatory Operations / QA to ensure optimal definition and...clinical systems like CTMS, EDC, eTMF, Planisware, Product Registry, Regulatory etc. required4 or More Years Experience in working… more
- Merck & Co. (Rahway, NJ)
- …to bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and ... Job DescriptionThe Director of Biologics Potency in Analytical Research &...launch.- The successful candidate will be responsible for resourcing planning , risk assessment strategies, talent development, and partnering to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …tools, and data strategies to support best in class diversity and patient voice planning , 3) Design, lead and implement the GCO delivery framework for diversity and ... related internal groups (eg patient advocacy, ID Office, field medical, regulatory affairs, etc.)-Establish and oversee indication or study specific demographic… more
- Merck & Co. (Rahway, NJ)
- …understanding of the regulatory environment, and a-vision to influence the regulatory environment.Nature and Scope of Position:The Director reports to the ... chemical and biochemical promcesses, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are currently recruiting for a Director , Global Marketing for Women's Cancer for the oncology portfolio.- The Global Marketing Director will ... plans, strategy development, launch and marketing execution and budget management.Ensure planning and readiness for senior business and strategy reviews and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior ... in collaboration with External Scientific Affairs dept.Responsibilities- Clinical Monitoring Planning : Oversees and coordinates Sponsor oversight of CRO clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of regulated BA, DMPK, biological sciences, clinical pharmacology, BA strategic planning , regulatory guidance, and in-licensing and has managerial experience. ... to oversee bioanalysis strategy from global development and global regulatory perspectives, set standards (industry best practices), ensures efficient… more
- Merck & Co. (Rahway, NJ)
- … regulatory filing, and publication. Specifically, The Senior Clinical Director May Be Responsible For: Evaluating pre-clinical and translational work for ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Merck & Co. (Rahway, NJ)
- …in 2023.We are seeking a leader to take the position of the Associate Director Global Marketing, who will be responsible for maximization of the late lifecycle ... opportunities for growth and expanded access for patients, lifecycle and LOE planning , and ensuring reliable global supply through close collaboration with our… more
- Merck & Co. (Rahway, NJ)
- …our products. -The successful candidate will be accountable for proactive resourcing planning , risk assessment strategies and will focus on talent development and ... with cross-functional development teams to enable pipeline decisions.- The Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at ... quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key… more
- Merck & Co. (Rahway, NJ)
- …and overall role administration. This role reports to Executive Director , SAP Platform Team. Primary Responsibilities: Leadership and StrategyProvide strategic ... robust SAP security policies, procedures, and controls.Ensure compliance with regulatory requirements and industry best practices.Manage user access and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and risk management activities for assigned product(s), including resource planning , oversees team's workload, anticipates potential issues and works towards ... cross-functional team for assigned product(s) to author or contribute to regulatory authority requests or communicationEnsures consistent and unified safety message… more
