- Merck & Co. (Rahway, NJ)
- …to lead and support facility operations, process development activities, compliance investigations/change management, authoring of GMP documentation, and lead other ... overall success of the pilot plant. The Facility Lead position reports to the Director of Operations/Head of SSO Pilot Plant and the successful candidate will be an… more
- Merck & Co. (Rahway, NJ)
- Job Description Position Description The Associate Director , Technical Operations within Global Clinical Supply (GCS) is responsible for managing all aspects of ... solid dosage forms, secondary packaging of vaccines/biologics, medical devices).Strong compliance mindset and understanding of cGMP.Demonstrated strong project leadership… more
- Merck & Co. (Rahway, NJ)
- …for manufacturing, warehouse operations, distribution, and --reporting to ensure compliance --as business strategies and requirements continue to evolve. Develops ... subject matter expertise within functional and technical teams in overall SAP solutions for Clinical and provides direction and guidance to drive ongoing configuration, enhancements, and integration effort. Service Management: Manage the total scope of IT… more
- Merck & Co. (Rahway, NJ)
- …for solution design for planning, warehouse operations, distribution, ensuring compliance with market requirements as global regulatory requirements continue to ... evolve. Develops subject matter expertise within functional and technical teams in overall CTSM solutions and provides direction and guidance to drive ongoing configuration, enhancements, and integration effort. Service Management: Manage the total scope of IT… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell...responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position… more
- Merck & Co. (Rahway, NJ)
- …monitoring in our clinical trials. Under the oversight of the Clinical Research Director (CRD) or Head of Site Management and Monitoring, the person is responsible ... execution.Escalates site performance issues to CRM and Clinical Research Director CRD.People and Resource Management:Manage CRA - career development, performance… more
- Merck & Co. (Rahway, NJ)
- …Description Position Description: Powerhouse Chief Engineer Under the direction of the Associate Director of Engineering, The Chief Engineer is responsible for ... the energy and resource sustainability efforts.Supporting special projects as directed by Associate Director of Engineering.Being the liaison between the Power… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas ... the Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business teams introducing improved systems experience, cost savings, and compliance .- Stakeholder CollaborationAdvocate for the Global HRIS and collaborate with ... respective regional leads to align and incorporate system maintenance controls.Collaborate across each functional area of HR working with COEs, HR and Business leaders to understand their specific requirements building strong relationships based on trust,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Associate Director FP&A position is an integral part of the finance ... any variances and implications on business performance. Works with Director of FP&A to streamline and improve reporting to...as well as Actuals reporting and analysis while ensuring compliance with alliance policies and procedures. Act as Alliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director , Field Medical Training will be responsible for the ... and Contingent Workers requiring therapeutic knowledge of the Daiichi Sankyo portfolio. The Associate Director , Field Medical Training will have a variety of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...as scientific symposium and medical congresses, within legal and compliance regulations.Collaborates across functions to support GMA MI&E activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …authorities. Represents DS in key interactions with Health Authorities. Ensures compliance of DS programs with regulatory requirements for diagnostics and ... devices.Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products. Provides guidance on planning, writing, review of key dossier documents for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the ... (ex: Biomarker Data, Medical Devices Data, etc.) are effectively developed in compliance with CDISC / SDTM industry standards for diverse DS Programs operating… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …by managing labeling development or approval for either the US or EU.Ensure Compliance with Core Data Sheets/Label Changes: Manages updates to Core Data Sheets for ... as well as for the review of country labeling deviations.Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the coded data, and adherence to regulatory authorities' requirements.Ensure compliance with the protocol, external/internal standards, Good Clinical Practices ... ensure all medical coding activities follow global SOPs, SOIs, and associate guidelines.Qualifications: Successful candidates will be able to meet the qualifications… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …robust publication plans for the Therapeutic Area and respective products. Mentor Associate Director Publication leads on publication planning and execution ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …matter expert in meeting or teleconferences with Health Authorities. Ensure compliance with international regulations. Ensure inspections readiness as well as ... direction and execute oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards, applicable regulatory guidelines, Policies,… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you.The Associate Director , End User Services is responsible for the end user service delivery ... the Americas. Reporting to the Americas Infrastructure Lead, the associate provides extensive, broad-based technical leadership, management experience and oversees… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you.The Associate Director , Strategic Content Development, Global Medical Affairs - Alzheimer's ... of symposia at major AD congresses and medical advisory boards, and scientific communication.The Associate Director is a key member of the NBG group responsible… more
