- Merck & Co. (Rahway, NJ)
- …Devices, Mentoring Staff, Ophthalmology, Pathophysiology, People Leadership, Physiology, Program Management , Regulatory Affairs Compliance {+ 4 more}-Preferred ... Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Practice and regulatory compliance in such arrangements. Contribute to the management of PV Regulatory Intelligence (PVRI) and dissemination across CSPV ... contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence:Contribute to the management of PV Regulatory … more
- Merck & Co. (South San Francisco, CA)
- …you passionate about leveraging cutting-edge AI/ML technologies to revolutionize drug discovery and development? The Pharmacokinetics, Dynamics, Metabolism, and ... AI/ML to support efforts in transforming the way PDMB leads the assessment of drug candidates. The successful candidate will join a dynamic Data Science team focused… more
- Genmab (NJ)
- …MS-Office Suite and Adobe Acrobat application and ability to work in electronic document management systemFor US based candidates, the proposed salary band for ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Merck & Co. (North Wales, PA)
- …and plans for developmental compounds and obtains cross-divisional senior management approval.Critically assesses drivers and barriers to reimbursement and market ... can enhance value and use of products.Implements programs to document the burden and cost of diseases, unmet medical...need, patient reported outcomes (PRO) and the value of drug therapy as outlined in the OR planning process… more
- Merck & Co. (Rahway, NJ)
- …collaborative projects and develop subject matter expertise- - Knowledge of order management , supply chain operations and document control - #MSJR ... Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address..., visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).- - Responsible for… more
- Genmab (NJ)
- …and ICH guidelines.Proficiency with writing tools such as MS Word, EndNote, document management systemsAbility to interpret and summarize tabular and graphical ... you ready to make a meaningful impact in oncology drug development and be part of a dynamic, collaborative...the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of ... the technology transfer, scale-up, and optimization of validatable biological Drug Substance (DS) / Antibody Drug Intermediate...with R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs… more
- Merck & Co. (Rahway, NJ)
- …Generate tables, listings, and graphics required for clinical trial decision-making, regulatory requests, clinical study reports, and new drug application ... biostatisticians and/or epidemiologists within BARDS, as well as stakeholders in data management , medical writing, and clinical operations to gather and document … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial monitoring and execution through RBQM activities. Accountable for the management , performance, and development, both technical and career, of direct reports, ... position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project… more
- Experis (St. Paul, MN)
- …and address and routing documents for approval in the company internal document database. Fielding requests from global regulatory associates for registrations, ... have attention to detail, critical thinking, and excellent time management skills which will align successfully in the organization....a global healthcare spin-off. Be a key contributor to regulatory affairs for medical devices and drug … more
- Pace Analytical Services (Cleveland, OH)
- …that work is completed efficiently. Use of software applications for data and document management and document generation. Proficient in Excel. #LI-RG1 ... at Pace(R) Join us as an Entry Level Chemical Regulatory Analyst, where you'll put your love of science...Obtains missing data as necessary. Use of the Content Management application for uploading SDS, PDS, and other documents… more
- Sutro Biopharma (South San Francisco, CA)
- …compliance with global (FDA, EMA, ICH) regulatory expectations for document content. Experience in oncology drug development is preferred. Responsibilities: ... in the principles of scientific writing and will work cross-functionally, advising the team on regulatory expectations for document content while maintaining… more
- Phoenix Closures, Inc (Aurora, IL)
- …Review reports, identify issues, and perform actions to correct/resolve issues in the regulatory document libraries in the ERP system. Assist in entering new ... requirements for incoming raw materials and outgoing finished products. Prepare document submissions and responses to customer regulatory requests, such as:… more
- Intertek (Cortland, NY)
- …and management throughout testing. Within policy guidelines, identify, properly document , and recommend engineering judgments. This position outline is a general ... Job Description Engineer - HVAC Safety, Regulatory Compliance, Cortland, NY Intertek, a leading provider...sample applicability. Set up and operate EUT; perform and document simple repairs on EUT as needed. Perform testing… more
- Globus Medical (Audubon, PA)
- …other Clinical Affairs personnel, as needed for IDE and PMA reporting Reviews Document Change Orders for Regulatory compliance, including drawings and labeling ... their lives as quickly as possible. Position Summary: The Regulatory Affairs Specialist assists with drafting, submitting and gaining...and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III… more
- General Dynamics Information Technology, Inc. (Frederick, MD)
- …Warfighter. The ORA provides full-service, oversight, and consultation for regulatory , clinical, non-clinical, manufacturing, data management , biostatistics, ... product technical, safety monitoring, and medical and regulatory writing support for FDA-regulated drug , biologic, medical device, and combination products. The… more
- VA Puget Sound Health Care System (Seattle, WA)
- …parenteral nutrition management , IV to PO conversions, sedation/analgesia management , and antimicrobial stewardship. Document clinical pharmacy activities in ... to Veterans, ensuring all local, VHA, DEA, and other regulatory body policies and regulations are adhered to. The...are adhered to. The incumbent will review and monitor drug therapy; provide professional advice and consultative services; educate… more
- Cedent (Boston, MA)
- …Ensure completeness and compliance of essential documents Manage regulatory document workflows and tracking systems Support eTMF management for inspection ... Thinking Attention to Detail Cross-functional Collaboration Written/Verbal Communication Time Management A key role ensuring regulatory compliance throughout… more
- Sunrise Senior Living (Oakton, VA)
- …manner. Review, read, notate, and initial the electronic health record to document and learn about pertinent information about residents. Receive medication updates ... according to times and utilizing the mobile med cart. Document and initial as medications are given and ensure...the development of the Individualized Service Plans (ISP). Risk Management and General Safety Partner with community team to… more
