- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Summary As Translational Strategy Leader, you will define and lead cross- project translational strategy and guide research across immunology related projects in ... as well as external research, (2) determine the implications for cross- project strategy, and (3) coordinate pre-clinical/clinical research plans to progress the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …plus Must understand the entire development process through engineering program and project management, conceptual design , detailed design , prototyping, ... Position Summary:The Project Manager (Finishing Line Equipment) is responsible for...appropriately within the team and expected designed timelines. The Project Manager will ensure timelines are met, budgets are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global regulatory requirements while incorporating flexibility and simplicity in the design of clinical labels.Role Responsibilities- Manage end to end label ... key performance metrics and collaborates with internal stakeholders and vendors to address project challenges as needed.- Serve as SME for Prisym 360 label phrase… more
- Eisai, Inc (Nutley, NJ)
- … project teams on statistical requirements and opportunities to improve study design and project outcomes.Knowledge of FDA and EMA regulations, ICH ... team and cross-functional partners to ensure the timely achievement of project deliverables and adherence to established timelines.Responsibilities include, but are… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for the marketed products. This position is responsible for the design and implementation of a statistical analysis plan (SAP), reporting pharmacoepidemiologic ... clinical safety team, this position provides feedback on the clinical trial design , and statistical analysis plan, and proposes more complex data analysis. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position leads very complex studies or entire drug project in study design , data analysis and interpretation of results ... and other documents with minimal supervision. This position interacts with global project teams and global Health Authorities, as well as contract research… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of this position are to create the model-based drug development plan, design , conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support ... Phase 2/3 studies, represent function on study and project teams, and participate in and contribute to regulatory...and participates in KOL and regulatory interactions at a project level, and interacts with regional and global … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regional entities are reflected into strategy and plans.- The GTL ensures global project team's responsibility for the identification and design of a sound, ... the engine of development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance. In this key… more
- Catalent (Philadelphia, PA)
- …refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label ... phrase library we can design single panel, booklet labels or our unique Peel-ID...placement of new contracts. Intake, assess, and action all project timelines submitted for traditional clinical packaging contracts.Maintain Master… more
- Merck & Co. (North Wales, PA)
- …of quantitative leadership in the innovation and application of research design and statistical analysis methods fundamental to effective pharmaceutical R&D.- The ... reports to effectively communicate results of safety evaluations to the project teamsMentor and guide junior staff in functional activities.Skills Education and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with technology suppliers and third-party contractors. Provide guidance to the capital project engineering function through design and installation of automation ... is directly responsible for leading the Engineering team in the successful design , construction, and commissioning of facility systems, as well as all process… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …level. Responsible for clinical program planning and execution (from study design , operational planning, start-up, conduct, reporting, and close out) including ... components of a large-scale global clinical program using strong clinical project and program management, leadership, decision-making ability, people management, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to make a difference? The Position Use medical and clinical expertise in design , implementation and monitoring of clinical studies (from Phase 1 to 4) in a ... medical & scientific input to regional evidence generation plan-ning and project strategic documents, including NNI Evidence Generation Plans and Product Development… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …resources. Serve as leader and prime advocate for your Risk Assessment, design , manage, support and direct risk assessment team. Manage stakeholders, create schedule ... required in technical discipline: Engineering, science or similar field. Pharmaceutical/Life Sciences project management professional plus a minimum of 1 year of … more
- Merck & Co. (Rahway, NJ)
- …pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, ... guidelines in the application of predictive model-based approaches in the design of development plans and study designAbility to influence regulatory strategies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Sankyo products. This position contributes to or independently leads the design , preparation and analysis of epidemiologic studies, including real-word evidence ... independently carries out various functions (eg, literature reviews, study design , preparation of data for statistical analysis to obtain...input from upper management that impacts more than one project team at a time. This position will also… more
- Insmed Incorporated (Bridgewater, NJ)
- …input into the drug development plan, researches and leads the statistical design , analysis, and reporting of clinical trials, and interacts with global regulatory ... teams.Lead or contribute to statistical innovation activities including innovative design , advanced analytics, data visualization and template development. Independently… more
- BioAgilytix (Durham, NC)
- …of supplies for laboratory needs and forecast future needs based on projected project needsMay serve as principal investigator on a projectMay prepare and submit ... deviationsManage project timelines/schedulingManage budget and revenue for projectsCommunicate with clientTrain analysts/junior scientistsDevelop assay… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and be able to provide essential specialist guidance and direction to project teams, senior leaders, and other colleagues to ensure optimal management of ... within CSPV and other functions and a wide range of cross-functional project teams on behalf of epidemiology group. Oversee all safety related epidemiological… more
- Lundbeck (San Diego, CA)
- …diseases. In this role, the successful candidate will be responsible for leading project teams to design and synthesize first-in-class small molecules and ... chemistry efforts on one or more projects, working with multi-disciplinary project teams in developing innovative, high-quality small molecule therapeutics Supervise… more