- Owens & Minor (Indianapolis, IN)
- …+ Employee stock purchase plan + Tuition reimbursement This role reports to the VP of Clinical Regulatory Compliance and provides day to day oversight of ... clinical regulatory compliance including but not limited to FDA regulations, accreditation standards, state licensure and regulatory requirements that… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …to inspire you and empower you to shine? Join us as a Senior Manager , Integrated Clinical Trial Data Process Excellence and Delivery based remotely reporting ... IRT/eCOA implementation and management, data transfers/ingestion, centralized monitoring, and/or regulatory submission experience. + Understanding of clinical … more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …Manager , Clinical Outcome Assessment Operations will support the implementation and regulatory compliance of Clinical Outcome Assessments (COAs) in ... changes in COA submission requirements due to new regulations. + Ensure all clinical studies comply with the latest regulatory standards. **Manage Vendor… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …in more than one therapeutic area is advantageous. + Knowledge in global regulatory and compliance requirements for clinical research, including but ... and empower you to shine? Join us as a Clinical Operations Manager based remotely reporting to...Lead(s): + Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …If so, be empowered to take charge of your future at Takeda. Join us a Manager , Clinical Data Validation Engineer in our Cambridge, MA office. At Takeda, we are ... + Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations. + Ensure compliance with own Learning Curricula, corporate… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …to the best of my knowledge. **Job Description** Objective / Purpose: The Senior Manager Clinical Data Management is responsible for timely and high quality data ... of Work, maximize effectiveness and maintain budgets. The Senior Manager Clinical Data Management provides and enables...and adopts technology improvements and tools for use in clinical data management processes. + Ensure compliance … more
- CVS Health (Indianapolis, IN)
- …team of CPC's, working closely with internal and external stakeholders and ensuring compliance with regulatory requirements. The Manager develops strategies ... staff to maintain their CEUs. Assist in preparing documentation for audits, compliance reviews, and regulatory inquiries. **Required Qualifications:** Minimum 5+… more
- Lilly (Indianapolis, IN)
- …+ Understand how design elements influence the ability to deliver on new regulatory expectations (eg decentralization of clinical trials, increase racial and ... programs, trials, and/or protocols, statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, decentralized clinical… more
- Lilly (Indianapolis, IN)
- …+ Understand how design elements influence the ability to deliver on new regulatory expectations (eg decentralization of clinical trials, increase racial and ... programs, trials, and/or protocols, statistical/inferential methods, rating instruments, regulatory standards, safety assessment, investigator/site management, decentralized clinical… more
- Sumitomo Pharma (Indianapolis, IN)
- … will collaborate with cross-functional teams to ensure statistical integrity, regulatory compliance , and innovative data-driven decision-making throughout the ... highly motivated, and experienced individual for the position of **Senior** ** Manager , Biostatistics.** This role will support clinical development programs… more
- Elevance Health (Indianapolis, IN)
- …locations. The ** Compliance Director** will help lead and enhance our clinical compliance initiatives, focusing on business support and advisory functions, ... The Compliance Director will assess and mitigate compliance risks, conduct regulatory research, and collaborate...requirements to diverse audiences. + Experience working within the clinical space or as a clinician. For candidates working… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …among functions represented at the Labeling cross functional teams including clinical , safety, medical affairs, device regulatory and commercial, to ... therapies to patients worldwide. Join Takeda as the Senior Manager , Global Labeling Devices. You will be responsible for...as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub… more
- Fresenius Medical Center (Indianapolis, IN)
- …local, state and federal regulatory requirements. Oversees OSHA and regulatory compliance related issues ensuring appropriate actions taken to ensure ... required resolution. Demonstrates pride in the quality of work, regulatory compliance , and the environmental cleanliness of the facilities in the Centralized… more
- Elevance Health (Indianapolis, IN)
- …inventory and production levels, and operational and plan risk, ensures quality, and regulatory compliance . **How you will make an impact:** Primary duties may ... ** Manager II Grievance/Appeals (RN)-California** **Location** : This position...and policy changes and to ensure state and federal regulatory compliance and resolution within the … more
- ThermoFisher Scientific (Indianapolis, IN)
- …champion and pursue world class quality, promote a GXP culture and assure regulatory compliance . **Key Responsibilities:** The Site Quality Head will be ... Quality Head is responsible for leading QA Leaders in Clinical Packaging to assure compliance with cGMP's,...or Masters a plus. + Significant managerial QA / regulatory compliance experience in the pharmaceutical, chemical,… more
- Walgreens (Greenwood, IN)
- …and ensures compliance with employment laws. + Partners with Store Manager to establish expectations and goals, promote teamwork and foster a shared vision. ... of medications and drug interaction awareness. Offers preventive and clinical healthcare services, including immunizations, diagnostic testing, and patient outcome… more
- Walgreens (Greenwood, IN)
- …and federal laws/regulations allow, accountable for performing day-to-day non- clinical pharmacy operations, administrative activities; Ensures efficient pharmacy ... to customers' requests in a timely manner and answers non- clinical questions to ensure a positive customer experience. Models...efficient workflow. + At the direction of the Pharmacy Manager or pharmacist, prepares, and files reports and records… more
- Highmark Health (Indianapolis, IN)
- …are achieved. + Ensure all activities are documented and conducted in compliance with applicable business process requirements, regulatory requirements and ... over a specified panel of members that range in health status/severity and clinical needs. The incumbent assesses health management needs of the assigned member… more
- Highmark Health (Indianapolis, IN)
- …discipline. + Function in accordance with applicable state, federal laws and regulatory compliance . + Implement all care management reviews according to ... utilization management or a related field **SKILLS** + Working knowledge of pertinent regulatory and compliance guidelines and medical policies + Ability to… more
- BrightStar Care (Indianapolis, IN)
- …with auto insurance * Clean background and no criminal record * Understands regulatory compliance with state and federal regulations * Adhere to HIPAA ... Registered Nurse (RN) Case Manager Summary Are you looking for a RN...reporting of organization activities. * Assures proper maintenance of clinical records in compliance with local, state… more