- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on ... management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in their… more
- Merck & Co. (Rahway, NJ)
- …for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong ... excellence in Compliance, Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in… more
- Merck & Co. (Rahway, NJ)
- …will report directly to the Chief of Staff to the General Counsel & Executive Director , Legal Operations , Innovation & Technology and will be based in Rahway, ... Job DescriptionThe Legal Operations , Innovation & Technology team's responsibilities include financial...operational effectiveness.We are seeking a dynamic and experienced Associate Director of Outside Counsel and Vendor Management to join… 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 pivotal role in managing the technical interface between our company and our External Partners (EP) for Active Pharmaceutical Ingredients (API) and intermediates. You will be responsible for providing process support, resolving production issues, evaluating… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high ... process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans, promotes data governance, and engages stakeholders to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary:The Associate Director , Oncology Value & Market Dynamics Training Manager is responsible for ... to access for patients across our portfolio of products. The Associate Director will develop, in partnership with other key stakeholders, innovative solutions for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management ... Operations for the Data Validation and Reporting function by...this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations , Pharmacovigilance, handling and processing of raw data and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across and effective alignment within (eg with translational research, clinical operations , clinical development, medical affairs CSPV and other internal groups) and ... outside of Daiichi Sankyo (eg clinical trial sites, CROs, collaboration partners); Supports effective direct communication with clinical sites in collaboration with clinical development staff.Consults with KEE's for advice on complex patient safety issues.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations , Regulatory Affairs CMC, and Clinical Development to collate the ... Initiatives in close collaboration with RD colleagues.Drive discussions with Clinical Operations and the scientific SMEs, prepare and Coordinate responses to queries… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …or other external process steps where appropriate.Ensure and execute smooth operations and technical support of the relevant HRIS Module(s) including technical ... process and annual cycle management, documentation, testing, training and support materials for end-users, handling of queries, troubleshooting, and quality control.Lead or support consulting and implementation projects in the area of SuccessFactors,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …cultures.. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position has advanced ... Leadership, Direction, and Strategy:In collaboration with Clinical Development and Clinical Operations as well as other BDM functions, sets the vision, direction,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: ... Provides the strategic direction to Biostatistics Data Management & Data Ops for EDC, edit checks, data quality listings, SAP, Data Management plan; Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …may be conducted or coordinated in partnership with members of the RD Operations organization or with the functional excellence teams of functions within the TA ... of the TA Leadership team and in partnership with members of the RD Operations organization or with the functional excellence teams of functions within the TA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liaisons to ensure successful implementation ... of CDx and data collection Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally For late-stage programs, executes the Diagnostic development strategy for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …10 or More Years Functional experience in Project Management, Business Operations , Finance, or related area required- Demonstrated success in program/project ... management, stakeholder engagement required- Demonstrated people leadership skills required- Experience working within global, cross-cultural environment. Japan business a plus; Bilingual a plus preferred TravelAbility to travel up to 20% Business meetings… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …work environment. This pivotal position will report directly to the Senior Director of Operations .Key Responsibilities Champion and lead the employee engagement ... Legend Biotech is seeking a Employee Engagement Manager as part of the Technical Operations team based in Raritan, NJ. Role OverviewJoin our dynamic team at Legend… more
- Merck & Co. (Rahway, NJ)
- …drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a strong, ... to strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing a team of pharmacometricians with diverse… more
- Merck & Co. (Rahway, NJ)
- …our company's mission of helping to improve and save lives.-Reporting to a Director of the Team, the Associate Director supports the implementation and ... maintenance of the Program.- The Associate Director has experience with pharmaceutical industry compliance programs, is comfortable working cross-functionally with… more
- Merck & Co. (Rahway, NJ)
- …are seeking a highly skilled and motivated Associate Principal Scientist/Associate Director with expertise in conducting outcome researching using real world data, ... informatics, health informatics, clinical informatics, epidemiology, health economics, biometrics, operations research, engineering, computer science or similar fields. Skills… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting to the Executive Director , RIIM , this role will be accountable to ensure a holistic Regulatory centric D ata M anagement ( R DM) capability ... c ross functional Leaders is critical. Th e Senior Director should have strong managerial experience, a high-level strategic...in local SOPs- - Data Centric Business System Owner Operations : Lead the regulatory data governance and standards team,… more
