- Legend Biotech USA, Inc. (Raritan, NJ)
- …Strong financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management : Ability to identify, assess, and mitigate ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (Rahway, NJ)
- …recurrence. Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End ... Job DescriptionAssociate Director , Business System Labeling Management Required...Data Management , Employee Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance… more
- Merck & Co. (Rahway, NJ)
- …regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program presentations ... Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T)… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... and fusion proteins. Within Mixed Modality, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requires skills in working in a fast-paced environment, continuous improvement, change management , and risk management . Experience working and managing ... research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM ( Risk Based Quality Monitoring) sets the vision… more
- Merck & Co. (Rahway, NJ)
- …extensive experience in design controls, device transfer, control strategies device risk management , and design verification testing to develop value-added ... with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project Management… more
- Merck & Co. (Rahway, NJ)
- …launch planning tool, ensuring adherence to timelines, budgets, and resource allocation. Risk Management : Identify potential risks and interdependencies across ... Job DescriptionAssociate Director , Launch Strategy and OperationsLocation: North Wales (Upper Gwynedd), PennsylvaniaDivision: Human Health US (HH-US)Therapeutic… more
- Merck & Co. (Rahway, NJ)
- … Process, Managing Engineering Teams, Operational Metrics, Performance Monitoring, Project Management , Research Databases, Risk Management , Status Reporting, ... Driving License:Hazardous Material(s):Required Skills:Budget Development, Business, Clinical Supply Chain Management , Clinical Trial Management , Compliance … more
- Merck & Co. (Rahway, NJ)
- …Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management , Regulatory CMC, ... Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is… more
- Merck & Co. (Rahway, NJ)
- …, Project Portfolio Management (PPM), Publications Management , Regulatory Compliance , Risk Management , Sourcing and Procurement, Strategic Planning ... program(s) ( ie Bulk Drug Product).- - Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within… more
- Merck & Co. (Rahway, NJ)
- …talent Development.-The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including ... The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering… more
- Merck & Co. (Rahway, NJ)
- …excellence in Compliance , Supply, Continuous Improvement, and Cost Management .--The Associate Director , External Manufacturing Operations will also assist ... goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).-… more
- Merck & Co. (Rahway, NJ)
- … Management , Pharmaceutical Process Development, Process Scale Up, Program Risk Management , Project Planning, Protein Characterization {+ 2 more}-Preferred ... pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research… 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 ... Auditor (CIA), Certified Management Accountant (CMA), Certified Fraud Examiner (CFE).Experience with Sarbanes-Oxley compliance .Big 4 Audit experience.Requisition… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management , and compliance in vendor agreements. Ability to ... bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic… more
- Merck & Co. (Rahway, NJ)
- …to Schedule and Budget for Deliverables, Leadership of Teams, Vendor Management , And Demonstrated Communication With Senior LeadersAPI Small Molecule Manufacturing ... and Potent Compound Handling ExperienceProcess Safety Management , Emergency Management , And Incident InvestigationsFacilitating Process Hazard Analysis and… more
- Bristol-Myers Squibb Company (New Brunswick, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary The Director , Quality Risk Management will drive consistent Global ... BMS network. This position will report into the Senior Director , Risk Management . Key Responsibilities:...with at least 3 years in risk management leadership position. Expertise in GMP compliance ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …forecasting to identify market trends, leading a high-performing team while ensuring compliance with legal standards. The Director will drive informed ... in? Are you ready to experiment with us? The Position The Director , Market Intelligence and Portfolio Insights will leverage Competitive Intelligence methodologies… more
- CLS-Group (Iselin, NJ)
- …integration of security architecture across various initiatives, with a focus on scalability, compliance , and risk management . Define, monitor, and enforce ... This position requires deep expertise in security architecture, a strong understanding of risk management , and the ability to influence and guide key decisions… more
- Aquestive Therapeutics (Warren, NJ)
- Job Summary: We are seeking a highly experienced and strategic Director of Advertising, Promotional & Labeling to lead regulatory review of promotional and labeling ... in the Medical, Legal, and Regulatory (MLR) Review Committee, ensure compliance with FDA regulations, and partner closely with Commercial, Legal, and… more
