- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line management, to ... DS is prepared to meet new or proposed global regulatory requirements and that DS has a voice in...cross-functional leaders incl. from across RD, Safety, Tech/Supply and Commercial to coordinate SMEs and engagement activities with trade… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) ... collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs, and other RD functions to ensure effective delivery of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and related materials that pertain to training objectives for use at Senior Leadership meetings.Special Projects/Change ManagementAssist the Director in the ... be part of the Compliance organization and will report directly to the Director , Compliance Training, Policy & Communications. This position will be responsible for… more
- Merck & Co. (Rahway, NJ)
- …in driving operational excellence. This role reports to Executive Director , SAP Platform TeamResponsibilities: Leadership and Strategy:Develop and execute the ... and developments align with business requirements, industry standards, and regulatory compliance.Define and enforce change control processes and methodologies to… more
- Insmed Incorporated (Bridgewater, NJ)
- …the reinforcement and ongoing growth of our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not have any direct ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of the Brand team for… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical, Regulatory , Statistical Programming, Data Management, and our Company's Research… more
- Merck & Co. (Rahway, NJ)
- …Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development (DD) Team designs, develops, and ... individual drug assets currently in clinical development with line of sight to commercial filing and launch. This team is responsible for all elements of combination… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Division colleagues to complete process characterization, technology transfer to commercial manufacturing sites and authoring of regulatory filing ... partner groups within Process R&D, Analytical R&D, our Manufacturing Division, and Regulatory CMC, to characterize new commercial manufacturing processes and… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... communication/publication components of overall medical operating plan.The Sr Medical Director provides strategic development, planning, implementation, and oversight of… more
- Merck & Co. (Rahway, NJ)
- …cancer patients globally.We are currently seeking an Oncology Competitive Intelligence Director specializing in Women's Cancers. This role is responsible for ... comprehensive understanding of relevant healthcare environment matters, including policy, regulatory , and health technology.Developing a global internal network of… more
- Merck & Co. (Rahway, NJ)
- …& Development Division , Human Health, and our Manufacturing Division - Senior Leaders.Executes business development and commercial activities in the evaluation ... Job Description Position Description: Director , Business Development Responsible for leading and executing business development and commercial activities which… more
- Merck & Co. (Rahway, NJ)
- …and driving improved outcomes.Demonstrated ability to successfully negotiate with regulatory agencies and senior operations leaders; escalates issues ... site, regional and global business partners to drive prioritization of regulatory compliance, continuous performance improvement, and integration of EHS performance… more
- Merck & Co. (Rahway, NJ)
- …there are important interactions with, inter alia, Quality Assurance, Finance, Regulatory , Clinical Supplies and legal in a highly matrix-based organization. There ... (CSSM), Clinical Quality Managers (CQMs).Engage with Functional Service Provider (FSP) Senior , Regional and local team to ensure adequate and appropriate resourcing… more
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible For:Evaluating pre-clinical and ... with talented and dedicated colleagues while developing and expanding your career.The Senior Director (Sr. Principal Scientist) has primary responsibility for… more
- Eisai, Inc (Nutley, NJ)
- …planning and supportive tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working with ... Essential Functions Medical Affairs Strategic Plans: Under the direction of the Senior Medical Director , work with key stakeholders, management, and functional… more
- Eisai, Inc (Nutley, NJ)
- …business processes. Responsible for approval of medical and scientific content of Regulatory , Safety, Scientific Affairs, Medical Affairs and Commercial outputs ... 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 and… more
- Eisai, Inc (Nutley, NJ)
- …Associate Director , Omnichannel Marketing and Media position reports to the Senior Director , Omnichannel Marketing (HCP and Patient). The associate ... deliver omnichannel and media specific marketing input and activities.The Associate Director of Omnichannel Marketing and Media is responsible for managing,… more
- Merck & Co. (Rahway, NJ)
- …cycle of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be ... statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ensuring that appropriate Corporate personnel… more
