- Merck & Co. (Rahway, NJ)
- …laboratories and/or CROs. Apply for the necessary study permits and licenses with support of local regulatory staff within the specified study timeline.Train the ... submission to regulatory agencies.Supervise trainees and provide mentorship and support to other GCR staff . Provides scientific and technical support to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for accurate and timely processing of all business requests for project team. Support Directors through Vice President, as requested, with a strong commitment to ... and/or trainings (as assigned). GDP training, GPM&L Project Review Meeting, GPM&L Staff Meeting, GPM&L Records Management Training, etc. Prepare agenda and assist in… more
- Merck & Co. (Rahway, NJ)
- …Associate Director will collaborate with a team of engineers and technical staff to support global and site-specific projects, facilitate technology transfer, ... team and governance forumsAuthor and complete regulatory filing sections, and support response to questions and pre-approval inspections from a product development… more
- Formation Bio (New York, NY)
- …and more efficiently.About the roleWe are looking for a detail-oriented and proactive Staff Accountant to join our growing team. You'll be an integral member of ... and coordination with internal stakeholders Perform monthly bank reconciliations and support other balance sheet reconciliations Prepare and book accruals and help… more
- Merck & Co. (Rahway, NJ)
- …function, ensuring compliance with policies, financial practices, and SOX requirements. Provide support and training for legal staff and outside counsel on ... skills.This role will report directly to the Chief of Staff to the General Counsel & Executive Director, Legal...Coordinate Comet/SAP roles for the OGC and manage end-user support and role recertification processes. Collaborate with the Legal… more
- Merck & Co. (Rahway, NJ)
- …Team. Effectively manage resources to ensure appropriately skilled and high - performing staff members are assigned to support the effective execution of the ... touch points with GCTO and Research and Development (R&D) staff in the US headquarters, or in the Global...and GCTO goals, initiatives and - expectations. Participate and support the goals and objectives of the GCTO Senior… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reporting, data visualizations, external data acquisition and validation, and tools to support project portfolio across drug programs. This role is responsible for ... in line with data transfer agreements. Manage and oversee the DM programming staff and Functional Service Provider subject matter experts at the functional level to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams of functions within the TA Oncology organization. The individual may also support , or lead initiatives intended to expand the Daiichi Sankyo global development ... for coordinating resource management of the TA Oncology organization with chiefs of staff of functions within the organization. In the addition, the individual will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other vendors to ensure high quality of laboratory data deliverables to support drug development processes and global submissions. This position provides leadership ... - Establishes company-wide laboratory data management strategies and processes in support of clinical development objectives.- Accountable for lab data management… more
- Merck & Co. (Rahway, NJ)
- …manages and develops talent.Proactively identifies new opportunities and gaps to support emerging needs and addresses by reallocating and training of existing ... staff and/or external recruitment.Creates an empowering, compliant, collaborative, and...team & all programs and studies.Approved administrative budget to support GCTO team (eg, salaries & travel).Country level operational… more
- Merck & Co. (Rahway, NJ)
- …is to provide the technical leadership and laboratory capabilities in support of late-stage pipeline commercialization and post-market commercial manufacturing ... support . BDSC supports stage 1 & 2 process validation...and people management.Serve as the scientific/technical mentor for junior staff .- Provide technical guidance in the various aspects of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reports, and mentors or acts as functional manager of skip-level or ex-US staff . This position requires strong knowledge about RBQM, and related processes, policies, ... Communicates and collaborates with other function leaders during this process to support decision making and execution. Develops overall outsourcing strategy for the… more
- Merck & Co. (Rahway, NJ)
- …area scientific staff via training, coaching, and mentoring. Drive and support a self-service data science mindset in our organization. - Deliver on the ... transformation strategy. - Further, the successful candidate will provide centralized support and expertise to teams across Research Laboratories. - Our projects… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immune disorders. SummaryDeliver the development and implementation of systems and programs to support the business functions of Daiichi Sankyo (DS) in the US, EU, ... assessments. Responsible for managing and mentoring a team of junior staff , on-site and offshore consultants, providing guidance, technical feedback, and fostering… more
- Merck & Co. (Rahway, NJ)
- …is to provide the technical leadership and laboratory capabilities in support of late-stage pipeline commercialization and post-market commercial manufacturing ... support . BDSC supports stage 1 & 2 process validation...biologics commercialization, serving as the scientific/technical mentor for junior staff .-Provide technical guidance in the various aspects of Cell… more
- Eisai, Inc (Nutley, NJ)
- …supplementary applications. Essential Functions Provide global regulatory leadership in support of the global development, registration, and life-cycle management of ... the project team throughout the product lifecycle. Provide senior staff advice and guidance on regulatory issues, especially for...of the meetings with FDA, EMA, PMDA. Provide strategic support for meetings with other Health Authorities the CDE.… more
- Merck & Co. (Rahway, NJ)
- …clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible for the design and maintenance of ... statistical datasets that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is a key… more
- Eisai, Inc (Nutley, NJ)
- …profile, we want to hear from you. The Clinical Trial Assistant will support all phases of clinical study activities (feasibility, start-up, conduct and close-out) ... the direction and supervision by study Clinical Operations Lead(s). Plans, support , creates, and communicates clinical study timelines. Gathers input from… more
- Merck & Co. (Rahway, NJ)
- …analysis to impact pipeline development and set strategic direction - Mentors technical staff to develop team members scientifically and support the execution of ... and capabilities at a department level to develop institutional understanding and develop staff across the organization - - Education Minimum Requirement: - Ph.D. in… more
- Merck & Co. (Rahway, NJ)
- …GMP Compliance will report to the head of the Global Quality Compliance Support organization.- The responsibility of this position crosses all Human & Animal Health ... Programs, ICH Q10, Innovation, IS Audit, Management Process, Mentoring Staff , Pharmaceutical Regulatory Compliance, Policy Development, Process Facilitation, Process… more
