- Eisai, Inc (Nutley, NJ)
- …subjects. Excellent interpersonalandcollaborativeskills with astrong customer-centricfocusare necessary. Project management with ability toplan,organize, ... direction allowing us to meet Eisai business needs. Strong understanding of project management principles and Systems Development Life Cycle standards and… more
- Eisai, Inc (Nutley, NJ)
- …Excellent interpersonalandcollaborativeskills with astrong customer-centricfocusare necessary. Strong project management with ability toplan,organize, ... direction allowing us to meet Eisai business needs. Strong understanding of project management principles and Systems Development Life Cycle standards and… more
- Eisai, Inc (Nutley, NJ)
- …solving skills and excellent written and verbal communication skills Financial/budgetary and project management experience Travel is estimated at 20% of time, ... include: designing, implementing and evaluating the marketing plan; leading management and stakeholder reviews of plans; monitoring performance progress and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a motivated individual with a strong background in regulatory affairs and project management to support our cross-functional ... experience and the ability to manage and develop a team preferred. Project management certifications (eg, PMP, PRINCE2) preferred.Experience as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders.Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and coordination ... supports for global and US regulatory activities. The Manager RPM is responsible for supporting...The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL)… more
- Merck & Co. (Rahway, NJ)
- … compliance.-Essential Duties and Responsibilities:Program Leadership and Technical Project Management :Provide program leadership in the development, ... with a strong understanding of quality management systems and regulatory compliance.Exceptional project management skills and principled verbal… more
- Merck & Co. (Rahway, NJ)
- …to ensure appropriate and timely corrective actions are implemented (where warranted). Provides project management support of EQA. Assists in the preparation and ... with all domestic and foreign regulations and compendia governing plant operations. Strong project management skills Trained Quality Risk Management (QRM)… more
- Eisai, Inc (New York, NY)
- …solving skills and excellent written and verbal communication skills Financial/budgetary and project management experience Travel is estimated at 20% of time, ... include: designing, implementing and evaluating the marketing plan; leading management and stakeholder reviews of plans; monitoring performance progress and… more
- Merck & Co. (Rahway, NJ)
- …an international environment.Well versed in risk-based approaches to inspection preparation/ management .Excellent project management and organizational ... and training materials. Identifies industry best practices and leads knowledge management regarding important regulatory developments.Leads/co-leads and acts as… more
- Merck & Co. (Rahway, NJ)
- …relevant work experience.- Required Skills and Experience :Prior supervisory and project management experiences are necessary.Solid knowledge of statistical ... and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical, Regulatory , Statistical Programming, Data Management , and our… more
- Merck & Co. (Rahway, NJ)
- …and present ideas to senior leadershipExcellent communication, presentation, negotiation, project management , and organizational skillsExperience with leading ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… more
- Merck & Co. (Rahway, NJ)
- …and written reports to effectively communicate results of clinical trials to the project team, Company Management , regulatory agencies, or individual ... design.Strong scientific leadership in design and analysis of clinical trialsStrong project management skills. --Solid knowledge of- statistical and data… more
- Merck & Co. (Rahway, NJ)
- …the leadership level including the development of electronic submission deliverablesStrong project management skills; A program leader; Determines appropriate ... database expertise. Familiarity with statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine regulatory … more
- Merck & Co. (Rahway, NJ)
- …to manage conflicting priorities, often in time-sensitive environments, with effective project management skillsHigh degree of ethics and ability to ... and maintain digital tools to support best-in-class strategic planning and performance management across the policy function and work with the AVP, Strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services Project Management and Operational Management .Develop a strong, ... Leads and the business users to define user information needs.Provide informatics project management , SDLC Quality Model expertise, and computer system… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Work closely with study site operational staff to ensure timely and accurate updates. Project Management : Demonstrate advanced project management skills, ... discussions with internal and external cross-functional teams. Present findings and project statuses to cross-functional leadership and alliance management … more
- Merck & Co. (Rahway, NJ)
- …sampling methods, mathematical skills critical thinking, problem solving and project management .Excellent communication skills, people skills, and proficient ... the Rahway site.Integrates EHS programs into daily operations to assure regulatory compliance, continuous improvement and performance objectives are met around EHS.… more
- Merck & Co. (Rahway, NJ)
- …and maintain good working relationships across different functional areas. Solid project management skills. Excellent leadership, verbal and written ... scripts that facilitate the transfer of electronic data files into the Clinical Data Management System (CDMS). A key aspect of your role will be to collaborate with… more
- Merck & Co. (Rahway, NJ)
- …confidently and effectively in English on business and legal topics. Moreover, strong project management skills and the ability to plan and conduct complex ... America and Europe.Preferred candidates will have a strong working knowledge of regulatory and compliance laws, including the US Foreign Corruption Practices Act… more
- Merck & Co. (Rahway, NJ)
- …skillsAbility to function well both independently and collaborativelyStrong project management skillsDemonstrated interest in statistical methodology ... as companion diagnostics. The position is also responsible for supporting regulatory filing related to oncology biomarkers. -This position requires solid statistical… more
