- 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
- Envista (Brea, CA)
- …and computer literacy in Microsoft Office suite, databases and electronic document management systems Enthusiastic self-starter with excellent verbal, written, ... regulatory developments. Performs special projects at the direction of the Regulatory Affairs Management . Responsible for assembling an CE technical file.… more
- Omega Medical Imaging LLC (Sanford, FL)
- …We're seeking a proactive, experienced leader to innovate and manage our Quality Management System (QMS) and regulatory activities. In this on-site role (no ... Key Responsibilities: Lead and continuously improve Omega's QMS to ensure regulatory compliance and product excellence. Guide 510(k) submissions, CE marking, and… more
- Katalyst HealthCares and Life Sciences (Trenton, NJ)
- …global regulatory interactions with health authorities, with supervision. Facilitate document review meetings and discussions. Develop and maintain knowledge of ... development processes and post-approval requirements. Experience in developing CMC regulatory strategy. Experience in project management . Have a… more
- Wheels, LLC (Schaumburg, IL)
- …Cross-Functional Collaboration: Work with Compliance Services leadership, Sales, Account Management , and Client Services to ensure regulatory requirements ... Job Description: JOB OVERVIEW The Jurisdictional Management Analyst will collaborate with the Director on upcoming jurisdictional changes that relate to Title and… 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
- South Florida Regional Transportation Authority (Pompano Beach, FL)
- …Establish and oversee governance and policies to ensure data integrity, security, and regulatory compliance. Budget Management : Develop and manage the IT budget, ... agency's strategic goals, focusing on enhancing commuter rail operations, customer service, regulatory compliance, and issues facing IT in the public sector. Job… more
- BioSpace (San Rafael, CA)
- …Develop and maintain efficient systems for Business Development collaboration, communication, and document management (such as MS Teams, data rooms, distribution ... part of a team.7+ years experience with the biotech industry and regulatory landscape. Skills: Project Management : Planning, execution, monitoring, and control.… more
- JF Petroleum Group (Lakeland, FL)
- …in overall management of individual projects as needed. Assists in regulatory notifications and scheduling of inspections with city and state. Manages and ... Construction Project coordinators are responsible for ensuring all construction documents and regulatory forms are completed and provided to customers in a timely… more
- RHA Health Services (Wilson, NC)
- We are hiring for: Certified Alcohol and Drug Counselor / CADC Type: Regular If you are a positive and personable individual looking for a satisfying and fun ... challenges, join our team at RHA Health Services! A Certified Alcohol and Drug Counselor possesses knowledge and is able to apply substance use/abuse treatment to… more
- Chesapeake (Manheim, PA)
- …location. Perform pre-trip and post-trip safety inspections of vehicle and equipment. Document findings of inspections and ensure appropriate action is taken with ... rules and practice defensive driving techniques. Observe all company, industry, and regulatory guidelines regarding the safe operation of equipment in the delivery… more
