- 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)
- …who are passionate about driving impactful changes. Position Overview: As the Associate Director of Launch Strategy and Operations , you will lead the enterprise ... Job DescriptionAssociate Director , Launch Strategy and OperationsLocation: North Wales (Upper Gwynedd), PennsylvaniaDivision: Human Health US (HH-US)Therapeutic… 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)
- …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)
- …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)
- …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)
- …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)
- …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)
- …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
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Associate Director , Clinical Programming must have expertise in addressing technical challenges in the ... skills in SAS systems and application development and experience. The Associate Director must be a highly specialized individual contributor or functional manager… 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
- 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 ... discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations / data management or related area. 5+ years of experience in GCP… more
- Merck & Co. (Rahway, NJ)
- …to identify opportunities for improvement and tackle challenges, balancing effective operations with transformative initiatives.- The Associate Director , Quality ... As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in support of our QMS Purchasing… 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)
- …that enables our customers to adapt Industrial Hygiene requirements into daily operations .Being a change agent to ensure all changes to standards, guidelines, ... systems and tools achieve the desired outcome.Partner with regional and site EHS personnel to implement effective Industrial Hygiene programs through communication tools, training, and project plans.Evaluate, monitor and communicate the effectiveness of… more
