Manager, Compliance and Regulatory Affairs
4 weeks ago
Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure™. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial's imaging to optimize the opportunity to demonstrate efficacy. Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world's largest and most preeminent iCRO in oncology. The Manager, Compliance and Regulatory Affairs is primarily responsible for assisting the Compliance and Regulatory Affairs Management in executing day-to-day tasks associated with managing, maintaining, and continually improving Imaging Endpoints' compliance to meet regulatory requirements. The Manager, Compliance and Regulatory Affairs is a compliance and solutions oriented individual; providing regulatory support to IE's iCRO and SMO. RESPONSIBILITIES Regulatory Affairs Provide regulatory assistance within the regulations of investigational products and quality standards, specifically: 21 CFR Part 312, 314, 50, 54,210, 211, 11, ICH E6(R2), Clinical Trials Imaging Endpoints Process Standards, GDPR, HIPAA, Risk Management, BIMO, and ISO 9001. Interface with Scientific Affairs, Operations, and Clinical departments on regulatory issues providing expertise and support as required. Develop and manage IE's regulatory intelligence program by assessing current regulatory trends in the industry and developing a process to identify, control, and maintain documents of external origin. Perform regulatory review and approval of scientific, clinical, QMS, and regulatory documents. Project specific (e.g., Imaging Manuals, Image Review Charters, Interim and Final Reports) Criteria assessments Deviations, CAPAs, and other investigations with regulatory impact Regulatory, clinical, and scientific standard operating procedures (SOPs) Business proposals, RFls, and other client facing documents Work with SA and DM to provide regulatory guidance related to data or reporting used to support product submissions or communications to regulatory agencies. Interface with Compliance and Regulatory Affairs senior management to implement regulatory strategies and plans to facilitate continuous improvement of the QMS regarding regulatory affairs initiatives. Provide regulatory support for internal audits, sponsor audits, and regulatory inspections. Interface with vendors that provide Regulatory support and Compliance related services. Interface with Sponsors/CROs with respect to regulatory strategy and study requirements. Provide Regulatory training to IE personnel related to current industry practices and interpretation of FDA guidance, regulations, and standards. Assist the Chief Compliance and Regulatory Affairs Officer in establishing and reporting quality and regulatory metrics. Compliance and Document Management Develop SOPs and controls related to regulatory requirements for GxP document management. Assist in establishing, implementing, and maintaining QA procedures and controls to develop an effective, efficient, and compliant IE QMS document change management program. Responsible for the quality of documentation created and approved to support GxP activities for IE and sponsor related projects. Perform other duties as assigned by Compliance and Regulatory Affairs senior management. Act in a supporting role to the QMS Specialist position. EDUCATION AND EXPERIENCE Bachelor's degree in pharmaceutical sciences or other related scientific disciplines. Minimum six (6) years of experience in a regulated industry with at least four (4) years of experience in pharmaceuticals and/or medical device. QMS experience. Imaging Core Lab and/or Contract Research Organization experience preferred. Knowledge and understanding of 21CFR Part 211, 21CFR Part 312, IS 9001, and Good Clinical Practices (ICH E6 GCP), Good Documentation Practices (GDP) and Good Manufacturing Practices (GMPs) preferred. Proficiency in MS Office and internet applications Past experience with electronic document management systems in life sciences industry. SKILLS Superior attention to detail, particularly in written documentation Service oriented approach, flexible, and proactive Self-driven, ability to get the job done with little supervision, can-do positive attitude Ability to excel in a team environment Ability to work in strict compliance with all procedures, rules, and regulations Ability to manage projects and deliverables with a high level of accuracy and completeness Maintain strict confidentiality of sensitive data, records, files, conversations, etc. Must be self-motivated and able to grasp new concepts quickly Excellent hands-on computer skills with thorough knowledge of Microsoft Office to include Word, Excel and Power Point IMAGING ENDPOINTS' TEAM CHARACTERISTICS Passion to Connect Imaging to the Cure™ and pursue a meaningful career by improving the lives of cancer patients through imaging Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints Integrity and high ethical standards; we always do the right thing High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day's objectives while striving to improve ourselves and IE everyday Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else PHYSICAL REQUIREMENTS While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus. Travel: Estimated10-20% travel (domestic and international)
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Manager, compliance and regulatory affairs
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Hyderabad, India Imaging Endpoints Full timeImaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (i CRO). We are passionately focused on our vision to Connect Imaging to the Cure™. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to...
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Manager, Compliance and Regulatory Affairs
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hyderabad, India Imaging Endpoints Full timeImaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure™. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We...
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Manager, Compliance and Regulatory Affairs
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hyderabad, India Imaging Endpoints Full timeImaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the Cure™. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We...
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Hyderabad, Telangana, India Imaging Endpoints Full timeRegulatory Affairs ManagerImaging Endpoints is an Imaging Technology and Imaging Clinical Research Organization (iCRO) that is passionately focused on its vision to Connect Imaging to the CureTM. The company works every day to advance imaging science, technology, and services to bring curative technologies to humankind. We are seeking a talented Regulatory...
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Hyderabad, Telangana, India Imaging Endpoints Full timeJob Title: Manager, Compliance and Regulatory AffairsImaging Endpoints is a leading Imaging Technology and Imaging Clinical Research Organization (iCRO) passionately focused on our vision to Connect Imaging to the CureTM. We are seeking a seasoned Manager, Compliance and Regulatory Affairs to join our team and contribute to our mission to customize each...
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