- Twist BioScience (South San Francisco, CA)
- …continuous improvement, technical excellence, robust software development practices, and regulatory compliance .Software Development & Implementation: Oversee the ... Sr . Director , Manufacturing Execution System (MES)...our proprietary MES technologies will ensure strict adherence to regulatory requirements, optimize complex biological manufacturing processes, and align… more
- Eisai, Inc (Phoenix, AZ)
- …approved promotional clinical trials, patient access to medication, and regulatory / compliance guidelines preferred.Experience with account planning and ... If this is your profile, we want to hear from you. The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology… more
- Merck & Co. (Rahway, NJ)
- …Guidelines, Life Science, Medical Writing, Motivation Management, Prioritization, Problem Solving, Regulatory Compliance , Regulatory Documents {+ 4 ... clinical data/medical protocol deviations in collaborations with the Clinical Director . Other responsibilities include: Collaborating cross-functionally in the development… more
- Merck & Co. (Upper Gwynedd, PA)
- …- Associate Principal Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/ Sr Principal Scientist in ... Application (BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical Process… more
- Tris Pharma (Monmouth Junction, NJ)
- …Director / Director , Procurement. Title and salary commensurate with experience. The Director / Senior Director , Procurement is responsible for multiple ... negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and regulatory … more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a key role in scaling our biologics capabilities… more
- Repligen (Waltham, MA)
- …global public company is looking for a strong, experienced, and technically sound Senior Director , Assistant Controller, who will own the Company's accounting ... reporting (ICFR) in compliance with Sarbanes-Oxley (SOX) requirements.Ensure compliance with accounting standards and regulatory requirements, including SEC… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across the Novo Nordisk US Operations, including ED&AA, IT, Ethics and Compliance , Commercial, Patient Services, CMR (Clinical, Medical, Regulatory ), Finance, ... IT teams to ensure a strong data and technology foundation Engage senior leaders to drive strategic technology transformations Physical Requirements 10-20% overnight… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Repligen (Waltham, MA)
- …role will be based in Waltham, MA and will report to the Sr . Director , Quality - Quality Network Leader, Chromatography & Proteins.ResponsibilitiesThe ... deviation support, root cause analysis, customer complaint management, hosting customer/ regulatory audits and Certificate of Quality generation at an...Director , Quality will be responsible for:Maintaining site … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with customers. Relationships This position reports into a Vice President or Sr . Director within the National Account Market Access Teams. Internally, ... Reimbursement), HEOR, Marketing, Commercial Sales, Medical Affairs, and Legal & Compliance . External relationships include Customers as outlined in the Purpose of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring, development, and ... in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations...and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of… more
- Merck & Co. (Rahway, NJ)
- …integrating state-of-the-art technology and applying rigorous scientific and ethical standards.The Senior Director has primary responsibility for the planning ... development (pre-clinical to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development,… more
- Merck & Co. (Rahway, NJ)
- …controls approach within Device Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and ... Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T)… more
- Merck & Co. (North Wales, PA)
- …execution elements (eg operational reviews, issue escalation/mitigations, presentations at Sr Management meetings, program level cross functional meetings and ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensure consistency with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing ... actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with… more
- Merck & Co. (Durham, NC)
- …Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization ... - Knowledge of lean principles, equipment design, and preventative maintenance.- Regulatory - Global regulations and compliance requirements governing… more
- Novo Nordisk Inc. (WA)
- …locally and globally. Relationships Reports to the Market Access and Public Affairs Senior Director , Policy. Other internal relationships include a dotted line ... in Plainsboro, NJ or Washington, DC. The Position The Director - US Tax, Trade, IP works on complex...other Market Access & Public Affairs teams, Medical, Legal, Compliance , Communications and other key stakeholders locally and globally.… more
- Merck & Co. (North Wales, PA)
- …role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the ... of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams,… more
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