- Merck & Co. (Rahway, NJ)
- …approvals and systems are in place to maintain the scientific, technical and regulatory quality of all CMC submissions, correspondence, and interactions with ... , Mentoring Staff, People Management, Pharmaceutical Management, Professional Networking, Regulatory Communications, Regulatory Compliance Audits, … more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the regulatory … more
- Insmed Incorporated (San Diego, CA)
- … of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality ... Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high ... s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs … more
- Eisai, Inc (Nutley, NJ)
- …significant clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in Clinical Quality ... industry-wide QA community, present, publish at conferences, journals on clinical quality topics.Build and manage overall relationships with regulatory bodies… more
- Eisai, Inc (Providence, RI)
- …and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance ... activities. Eisai Salary Transparency Language:The base salary range for the Director , Clinical Quality Assurance is from :195,000-256,000Under current… more
- Merck & Co. (Rahway, NJ)
- …Life Cycle deliverables and testing.Act as a liaison with respect to the Quality Management System and Compliance pillars of Global Development Quality ... Quality Assurance Systems, Quality Management, Quality Oversight, Quality Risk Management, Quality Systems Compliance {+ 5 more}-Preferred… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …center intake, Technical Complaints handling, customer care and Triage to ensure regulatory compliance Lead efforts to optimize call center workflows, implement ... internal workflow timelines and performance metrics to ensure departmental KPIs and regulatory compliance are met Lead deviation management activities, including… more
- NVA (Yuma, AZ)
- …process for medical protocols, staffing, manage associate veterinarians, assuring regulatory compliance , leadership development and provide overall medical ... Ironwood Veterinary Clinic, located in Yuma, AZ, is looking for aMedical Director / Managing Veterinarian to join our practiceIronwood Veterinary Clinic in Yuma,… more
- Merck & Co. (Rahway, NJ)
- …packaging & device development and technology teams, supply chain, operations, quality , analytical, regulatory , and project leaders. The successful candidate ... maintain strong relationships with internal stakeholders, including packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures ... cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE)...assure regulatory compliance and meet regulatory reporting timelines. Controls and assures the quality… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... pipeline impact and lead a talented group of pharmacometricians.This director will be part of a leadership team responsible...cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go… more
- Merck & Co. (Rahway, NJ)
- …drug substance and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support ... relationships with internal stakeholders, including supply chain, packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and… more
- Merck & Co. (Montgomery County, PA)
- …the Pipeline Advertisemen We are currently recruiting for several Associate Director positions within US Marketing, covering Physician (HCP), Consumer (HCC), ... collaborating across multiple stakeholders (including sales, marketing operations, Legal, Regulatory , Medicals, etc.) to drive promotional execution. This AD will… more
- Merck & Co. (North Wales, PA)
- …Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... minimum of 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development and review of regional / global policies and procedures. Ensure compliance with all Company and Regulatory requirements.Work with outsourcing ... research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure… more
- Merck & Co. (Rahway, NJ)
- …and maintain strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory , manufacturing, and Supply Chain to ... Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE the Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Data Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.- ... to database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory compliance - Ensures that Data Management Plans… more
- Insmed Incorporated (San Diego, CA)
- …with GCP, 21 CFR Part 11, and CDISC ODM StandardsData Quality & Compliance :Ensure EDC systems comply with regulatory requirements (eg, FDA, EMA, ICH-GCP) and ... technical expertise and system documentationEnsure data integrity, system reliability, and regulatory compliance across all phases of clinical developmentTeam… more
- Merck & Co. (Rahway, NJ)
- …and maintain strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory , manufacturing, and Supply Chain to ... Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate ...party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate… more
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