- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... protocols are consistent with CDP and aligned to achieve the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, ... Supplements (PAS, CBE-0, CBE-30), Annual reports, Lot Distribution Reports, Biological Product Deviation Reports, and Drug Listings. Ensures that CMC documentation… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (GPT) for these plans, ensuring appropriateness throughout the product 's lifecycle and across different indications.Represent Global Regulatory Affairs on ... the GPT (Global Project Team), Daiichi Sankyo governance processes, and on Joint Alliances.Assess and articulate regional interdependencies, program regulatory risks, and opportunities in the development of global regulatory strategy and plans, considering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Program Management is a senior position responsible for effectively ... wide range of functions in Daiichi Sankyo (DS). Reporting to the Sr. Director , Enterprise Program Management, this position requires a capable leader with strong… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Business Systems and Process Improvement leads procurement efficiency and continuous improvement initiatives within Animal Health ... like RPA, Celonis, and AERA. Reporting to the Vice President of AH-GSM, the Director is a key member of the leadership team driving digital transformation withing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Policy Development and Strategy is a key leadership role in the Global Public Policy Strategic Planning & External Engagement ... engagement across -Global Public Policy (GPP) and the broader enterprise on above product policy and political issues, working closely with the Executive Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead and core DAST membership to build ... on customer insights, external landscape, and internal information including overall product development plans.- Proactive planning for asset milestones to account… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting ... Ensure metrics for reporting purposes are readily available for presenting at senior leadership meetings.Ensure and lead the establishment of the Quality Systems for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to meet smooth transition with other sub projects with respect to supply, product quality and stakeholder satisfactions. Responsible to communicate and escalate to ... Senior CMC Lead regarding the activity status and potential...or More Years Extensive experience in project management, process, product , and/or analytical development activities and pharmaceutical/oncology project development… more
- Merck & Co. (Rahway, NJ)
- …including the prioritization of indication filing opportunity recommendations to senior management. Develops and maintains tumor and indication expertise relevant ... prioritization discussions.Leads and/or contributes to development of the asset ( product ) level value and implementation (V&I) goals and tactical plan,… more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team ... portfolio and influence bridging strategies across the portfolio. The Biopharmaceutics Director will work with their direct reports to proactively develop and… more
- Merck & Co. (Rahway, NJ)
- …the Position The Animal Health IT Customer Master Data Management (MDM) Product Owner collaborates with stakeholders across all levels of the organization, from ... senior management to tactical execution- to understand customer master...that balances user desires with technology capabilities.Develop and maintain product materials, including training documentation, SDLC documentation, and … more
- Merck & Co. (Rahway, NJ)
- …oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, ... and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and… more
- Merck & Co. (Rahway, NJ)
- …continued R&D and drive access to life-saving medicines for patients? If so, the Director , Biologics Patent Attorney role , at our Company could be an ideal ... . - Responsibilities include but are not limited to: Working independently through product development teams to devise a patenting strategy with the goal of building… more
- Eisai, Inc (Nutley, NJ)
- …persuasive story and deliver clear and actionable recommendations to senior leadership.Continuously enhance analytics capabilities through new techniques, data ... teams across development phases from discovery through launch and initial product uptake. History of working in complex team environments with numerous/diverse… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director , Global Process Validation as part of the Technical Operations team based ... it is to deliver a best-in-class high volume marketed CAR-T product . The validation scope comprises a multi-site global manufacturing network responsible… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …whose responsibility it is to deliver a best-in-class high volume marketed CAR-T product . This effort is business critical and part of a multi-site global ... Represent MSAT at joint technical and CMC committeesPartner closely with senior leadership to achieve global alignment on all technical Carvykti scopeProvide… more
- Merck & Co. (Rahway, NJ)
- Job Description Job Title : Senior Specialist, AI Engineering We are investing in ourselves to change the way our company develops and harnesses the power of ... and unleash the potential of Artificial Intelligence. Reporting to the Director , Intelligence Automation & Hyperautomation within our Chief Technology Office, this… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Interaction & Collaboration level: Requires interaction with vendors and key senior stakeholders at Sr manager and director level in ... etc )Responsibilities Interaction & Collaboration level: Requires interaction with key senior stakeholders at director level and above cross functionally… more
