- Merck & Co. (Rahway, NJ)
- …skillsEducation/ExperienceBachelor's Degree +9 years of pharmaceutical, clinical drug development , project management , and/or medical field experienceOR ... Master's Degree +6 year of pharmaceutical, clinical drug development , project management , and/or medical field experienceOR PhD/PharmD Degree +2 year of… more
- Merck & Co. (Upper Gwynedd, PA)
- …Requirement: Bachelor's Degree +1 years of pharmaceutical, clinical drug development , project management , and/or medical field experience ORMaster's ... similar (Excel, PowerPoint, Word, Outlook, etc.) Preferred: knowledge of GCP, project management , process improvement, data analytics Position Qualifications :… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CROs, collaborate and represent QCP on internal teams including Clinical Development Operations, Global Project Management , Bioanalysis, and Drug ... at project teamsPerform modeling and simulation in support of clinical development of drug candidatesMaintain exploratory modeling and simulation workflows.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …close communication with CSO project Management LeadResponsible for the Clinical Label Development process which includes creation of master label text, ... Years of related experience, including Project Management , Clinical Supply Management , and/or Pharmaceutical Development . preferredOncology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …mid-term, long-term). These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management , Global Clinical ... and aligned guidance to asset teams to enable seamless tumor-specific clinical development and strategy.Responsibilities- Accountable for developing the Global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operations clinical trial activities, ensuring adherence to timelines, budgets, project , and quality plans, and relevant ICH/GCP Guidelines Review protocols to ... tracking of milestones as per contract). Ensure the global clinical operations systems for management of company...ensure compliance and highest quality standards in all GOMA clinical operational activities. Support the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThis position is responsible for supporting project management and operational activities as part of the ... Project Management Office and Business Excellence (PMOBE) sub-function within Clinical Safety and Pharmacovigilance (CSPV). PMOBE is the strategic planning… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports Phase 2/3 clinical ... of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically...project level, and interacts with regional and global project team members, senior management , and outside… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail ... accountability for operational study level time, cost and quality deliverables.Lead the development of the clinical study plan including critical path activities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& Simulation plans from FIH to post registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design ... Quantitative Clinical Pharmacology function. The incumbent will champion model-based drug development as an active team member of clinical and development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of… more
- Novo Nordisk Inc. (WA)
- …management activities. Takes ownership to deliver upon near-term North America Clinical Development (NACD) goals, including successful delivery of studies ... strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action ... (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management of DS Safety Notification Letter… more
- Merck & Co. (North Wales, PA)
- …solid understanding of the disease area, the functions and processes relevant to drug development , and project management principles as applicable to the ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development , Ophthalmology will focus on driving strategy, development , and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Aequor (Thousand Oaks, CA)
- …delivery and create repositories for all Process Development deliverables Project reporting including appropriate risk analysis Resource management in ... Senior Project Manager - CMC Integration Project Management What you will do...stakeholders, the Sr PM will need to understand the Clinical Development Plan and strategy to enable… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … and people skillsDemonstrated leadership qualities with the ability to act as project lead in the development and implementation of projects, processes and ... hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The PositionThis… more
- Merck & Co. (Rahway, NJ)
- … management organization capabilities (eg, lean six sigma, change management , executive-level facilitation, project management , negotiations, etc.).Ensure ... roles, and responsibilities.Demonstrated knowledge and success in portfolio managementPMP Project Management Professional (PMP) or Certified Project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …high integrity and strong ethics. Track record of teamwork, innovation and project management . Ability to think critically, strategically, and independently. ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
