- Merck & Co. (Rahway, NJ)
- …all in accordance with US and WW regulations, company policies and standard operating procedures .The Senior Director of Clinical Supply Systems (CSS) is a key ... translating strategic priorities into integrated operational team activities.- The Senior Director of CSS will also ensure measurable and sustainable results through… more
- Merck & Co. (Rahway, NJ)
- …accordance with US and WW regulations, company policies and Standard Operating Procedures .The Associate Director , Business Insights and Analytics (BI&A), is ... performance Delivering tools and solutions for digital visualizations of KPIsThe Associate Director , BI&A, will: Execute solutions to business needs by designing and… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Director of Medical Writing will be responsible for developing and implementing ... with applicable principles of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory guidelines. About You Bachelor of Science Degree,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that ... ingredients (API), biologics, vaccine drug substances and finished products. As Director , you will support Quality audits and health authority inspections and… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... advance a culture of scientific excellence and compliance with our company's procedures for recording time, data entry, and trainings. The successful candidate will… more
- Merck & Co. (Rahway, NJ)
- Job Description Director , Combination Product Regulatory CMC - (R5)- - - This Principal Scientist position is equivalent to a Director position. Under direction ... align on new combination product regulations and requirements to ensure internal procedures and processes are compliant for the pipeline. Participate in activities… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) is the Clinical Operations lead in a country/cluster and is responsible for execution of all Clinical Trials in scope for ... GCTO country operations.Adherence to GCP, local and global policies and procedures to conduct high-quality, inspection ready studies is essential. The position is… more
- Merck & Co. (Rahway, NJ)
- …audit and assurance services.Position Overview / Function and ResponsibilityThe Associate Director :Leads a small team through financial and compliance audits and ... efficiencies.Provides technical guidance and consultation on Company Policies and Procedures /Control Issues to the client and audit staff.Position QualificationsEducation… more
- Tris Pharma (Monmouth Junction, NJ)
- …in our Monmouth Junction, NJ facility for an experienced, hands-on SR. Director / Director , Procurement. Title and salary commensurate with experience. The ... Director / Senior Director , Procurement is responsible for...and other company and regulatory agency procurement policies and procedures throughout the organization. Ensures compliance with all current… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution ... internal medical documents through Medical Review Committee according to company procedures .Identify, analyze, and share insights, KPIs, metrics, and other outcome… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. SummaryThe purpose of the Senior Director , Forecasting & Business Analytics is to lead the forecasting and financial ... impacts of those changes.Change Management - Continuously review the financial procedures and drive new processes and/or system enhancements to improve… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and ... and to ensure compliance with Eisai policies & standard operating procedures .Self-study to ensure scientific credibility of existing and new therapeutic areas… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the vision and ... in project execution and deliverables. Oversees or initiates RBQM operating procedures and standards; monitors and enforces compliance of standard procedures… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Associate Director FP&A position is an integral part of the finance team supporting ... on reasons for any variances and implications on business performance. Works with Director of FPA to streamline and improve reporting to offer management insights to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …diagnostics and devices.Experience of drug development and drug regulatory procedures .Understanding of strategic and tactical role and deliverables of Global ... Regulatory Strategy in the Drug and Device Development and Commercialization process.Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives. Experience with communicating the regulatory… more
- Merck & Co. (Rahway, NJ)
- …equipment and processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in medical device assembly ... process development activities in accordance with relevant standard operating procedures .Identify and implement process improvements by working collaboratively with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …/ Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines ... to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines.Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …projects. Play a key leadership role in support of all processes and procedures around change management. This role requires comfort and independence in leading ... complex initiatives of high dollar value from inception through to implementation and ability to handle global projects through established interactions with Japan and Europe as required.Responsibilities- Lead the Global Finance and Procurement Capability… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Responsibilities:Supports positions from Director through Vice President, as needed, and in so doing will ... decisions in responding to questions related to assigned matters, processes, and procedures as applicable. Has in-depth knowledge of company policies related to… more
- City of New York (New York, NY)
- …(OPPT) is recruiting for one (1) Administrative Staff Analyst NMI to function as Procedures Director who will: - Plan and direct the activities of procedure ... the Medicaid Assistance Program (MAP) and HomeCare Services Program (HCSP) Director , Office of Procedures . The Director of Procedures maintains frequent… more