- Insmed Incorporated (Bridgewater, NJ)
- …ensure compliance with company policies and regulatory requirements on safety data reporting, collection, surveillance activities and documentation and that ... lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. He/She will be accountable for the day-to-day direction to Medical… more
- Insmed Incorporated (Bridgewater, NJ)
- …lists.OverviewThe Senior Director, Toxicology is a key member of the nonclinical safety team, reporting to the Executive Director, Head of Toxicology and Molecular ... you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies,… more
- Insmed Incorporated (Bridgewater, NJ)
- …national standards, regulations, and guidelines in partnership with Drug Safety and Pharmacovigilance (DSPV) representative . ResponsibilitiesAdditional ... QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities… more
- Catalent (St. Petersburg, FL)
- …customer service, with the highest integrity, focused on quality and compliance with partnership with Catalent St. Petersburg's customers and internal organizations. ... This position serves as a representative for their clients within the Catalent St. Petersburg...documentsProvides feedback to the appropriate department (ie regarding the compliance and adequacy of the documents reviewed as it… more
- Catalent (St. Petersburg, FL)
- …environment within the manufacturing area by overseeing and ensuring compliance with current Good Manufacturing Practices and Standard Operating Procedures ... the QA Specialists. The role is responsible for actively identifying compliance enhancements/improvements and leading project to deliver solutions. Furthermore, this… more
- Insmed Incorporated (Bridgewater, NJ)
- …Millennials™ lists.OverviewThe Director, Toxicology, is a key member of the nonclinical safety team, reporting to the Executive Director, Head of Toxicology and ... you will represent toxicology at cross-functional project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide ... and Payer), Brand Marketing, Training, Market Access, Trade, Legal, Compliance , Finance, HEOR, and Market Research. The position has...and patient access Customer Support Acts as a key representative of Novo Nordisk, on behalf of Patient Support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … compliance with requirements/regulations Act as a Novo Nordisk representative in interactions with Health Authority Inspector(s) at clinical trial sites ... directed by management to check principles of assuring patient safety , data integrity and regulatory compliance are...assuring patient safety , data integrity and regulatory compliance are sufficient Monitor and escalate GxP compliance… more
- Catalent (St. Petersburg, FL)
- …customer service, with the highest integrity, focused on quality and compliance with partnership with Catalent St. Petersburg's customers and internal organizations. ... This position serves as a representative for their clients within the Catalent St. Petersburg...meetings to provide Quality Assurance input with respect to compliance to cGMP requirements. Reviews and approves technical documents,… more
- Ann Graves CDC at The Hockaday School (Dallas, TX)
- …supervisor in compliance with Federal and State Laws. Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this ... as a whole. Essential Functions: Supervise and ensure the safety and wellbeing of the children Remain aware of...direct threat or significant risk to the health and safety of themselves or other employees. This job description… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stakeholders in the data area including functional representatives, corporate representative , IT, privacy, legal, compliance , IT security, etc.Responsibilities- ... business stakeholders from multiple functions, domain experts in privacy, security, and compliance and technology and IT owners from the digital transformation unit,… more
- Insmed Incorporated (Bridgewater, NJ)
- …master data management practices, as well as implementing and monitoring DSCSA compliance initiatives. This is a non-supervisory position This role oversees vendors ... and/or contractorsResponsibilitiesAdditional representative responsibilities will include, but not necessarily be limited to, the following: Strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design and development, execution within budget and timelines, quality and compliance . Relationships This position reports to the Corporate Vice President (CVP) ... and by enabling judgement-based decision and agility Is responsible for assuring compliance with the Novo Nordisk Quality system for Clinical Operations deliverables… more
- Aequor (Thousand Oaks, CA)
- …sections including the Summary of Clinical Efficacy, Summary of Clinical Safety , Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, ... Table of All Studies, briefing documents, and safety narratives Write other regulatory submission documents (eg, RTQs,...and regulatory submission strategy Act as a functional area representative and lead on product teams Assist with the… more
- Insmed Incorporated (Bridgewater, NJ)
- …working in a fast-paced, high energy, entrepreneurial environment.ResponsibilitiesAdditional representative responsibilities will include, but not necessarily be ... associated amendments and Special Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or safety issuesScientific, Program related: Integrated Study Team (IST) representative or IST leader on study team; Responsible before senior management for ... quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, Develops biomarker strategy in collaboration… more
- Perrigo (Eau Claire, WI)
- …the Role Quality Control Activities- Supports the Business Unit as the Food Safety /Quality representative at the Business Unit Weekly and Daily Operational ... Overview The Quality Assurance Engineer is the key Quality representative at the Business Unit Weekly and Daily Operational...correlate to the HACCP plans. Works with the Food Safety Specialist and cross functional HACCP teams to annually… more
- Telecare Corporation (Mccleary, WA)
- …necessary disciplinary action within the Nursing Department* Implements the safety program and actively participates in reducing Workers Compensation* Establishes ... of the fiscal budget* Ensures that the nursing department is in compliance with all related state, federal and local licensing regulations and requirements*… more
- Sutter Health (San Francisco, CA)
- …and facilitate financial stewardship and clinical excellence/care.Serve as a pharmacy representative for regulatory compliance surveys for inquiries dealing ... coordinators, and other members of the care team.*Reviews medication profile to ensure safety and proper use of medications. Alert to actual or potential medication… more
- Perrigo (Eau Claire, WI)
- …you. Description Overview The Associate Quality Engineer is the key Quality representative at the Business Unit Operational Reviews (DOR). This position is ... program in the quest for zero defect. Support activities to achieve compliance with Quality Management System (QMS) requirements and other applicable instructions… more
