Regulatory Affairs Specialist

SUMMARY

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 CureTM. 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 Regulatory Affairs Specialist / Regulatory Affairs Specialist II / Senior Regulatory Affairs Specialist is primarily responsible for assisting Compliance and Regulatory Affairs department management (e.g., Lead Regulatory Affairs Specialist, Director of Compliance and Regulatory Affairs) in executing day-to-day tasks associated with managing, maintaining and continually improving Imaging Endpoints’ regulatory systems to meet regulatory requirements. This Regulatory Affairs Specialist / Regulatory Affairs Specialist II / Senior Regulatory Affairs Specialist is a compliance and solutions oriented individual, facilitating timely and compliant document management decision making and providing regulatory support. This individual is instrumental in achieving business and stakeholder needs with respect to document management principles and practices.

REGULATORY AFFAIRS SPECIALIST

Regulatory Affairs Specialist coordinates and prioritizes work activities as delegated by Compliance and Regulatory Affairs Management. The RA Specialist reports results and updates to Compliance and Regulatory Affairs Management. Work with Compliance and Regulatory Affairs Management to develop robust processes and procedures. Prepare metrics and reporting to Compliance and Regulatory Affairs Management. The Regulatory Affairs Specialist adheres to QMS processes and procedures and provides training as necessary. Perform regulatory review and approval of Scientific, Clinical, QMS, and Regulatory documents. Reviews Project specific documentation (e.g., Image Review Charters, RPMPs, Interim and Final Reports). Performs regulatory review of Business proposals, RFIs, and other client facing documents. Understands and applies Imaging criteria assessments to support regulatory document reviews. Assists Compliance and Regulatory Affairs Management in coordination of work-related activities. Provide regulatory assistance within the regulations of investigational products and quality standards, including but not limited to 21 CFR Part 312, 314, 50, 54, 211, ICH E6(R2), Clinical Trials Imaging Endpoints Process Standards, GDPR, International GCP regulations, HIPAA, Risk Management, BIMO, and ISO 9001/13485. Interface with Scientific Affairs, Operations, and Clinical departments on regulatory issues, providing expertise and support as required. Assists in the development and management of IE’s Regulatory Intelligence Program. Assess current regulatory GCP trends in the industry and developing a process to identify, control, and maintain documents of external origin. Completes deviations, CAPAs, and other investigations with regulatory impact. Assists with creating and revising Regulatory, Clinical, and Scientific Standard Operating Procedures (SOPs). 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. Provide Regulatory training to IE personnel related to current industry practices and interpretation of FDA guidance, regulations, and standards. Assists the Compliance and Regulatory Affairs department in establishing and reporting quality and regulatory metrics. Develop SOPs and controls related to regulatory requirements as needed. 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.

EDUCATION AND EXPERIENCE

Bachelor’s degree a pharmaceutical sciences or other related scientific discipline. Minimum three (3) years of experience in a regulated industry with at least two (2) years of experience in pharmaceuticals and/or medical device, or equivalent. QMS experience. Imaging Core Lab and/or Contract Research Organization experience preferred. Knowledge and understanding of 21CFR Part 211, 21CFR Part 312, ISO 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 preferred

REGULATORY AFFAIRS SPECIALIST II

Regulatory Affairs Specialist coordinates and prioritizes work activities as delegated by Compliance and Regulatory Affairs Management. The RA Specialist reports results and updates to Compliance and Regulatory Affairs Management. Work with Compliance and Regulatory Affairs Management to develop robust processes and procedures. Prepare metrics and reporting to Compliance and Regulatory Affairs Management. The Regulatory Affairs Specialist adheres to QMS processes and procedures and provides training as necessary. Perform regulatory review and approval of Scientific, Clinical, QMS, and Regulatory documents. Reviews Project specific documentation (e.g., Image Review Charters, RPMPs, Interim and Final Reports). Performs regulatory review of Business proposals, RFIs, and other client facing documents. Understands and applies Imaging criteria assessments to support regulatory document reviews. Assists Compliance and Regulatory Affairs Management in coordination of work-related activities. Provide regulatory assistance within the regulations of investigational products and quality standards, including but not limited to 21 CFR Part 312, 314, 50, 54, 211, ICH E6(R2), Clinical Trials Imaging Endpoints Process Standards, GDPR, International GCP regulations, HIPAA, Risk Management, BIMO, and ISO 9001/13485. Interface with Scientific Affairs, Operations, and Clinical departments on regulatory issues, providing expertise and support as required. Assists in the development and management of IE’s Regulatory Intelligence Program. Assess current regulatory GCP trends in the industry and developing a process to identify, control, and maintain documents of external origin. Completes deviations, CAPAs, and other investigations with regulatory impact. Assists with creating and revising Regulatory, Clinical, and Scientific Standard Operating Procedures (SOPs). 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. Provide Regulatory training to IE personnel related to current industry practices and interpretation of FDA guidance, regulations, and standards. Assists the Compliance and Regulatory Affairs department in establishing and reporting quality and regulatory metrics. Develop SOPs and controls related to regulatory requirements as needed. 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.

EDUCATION AND EXPERIENCE

Bachelor’s degree a pharmaceutical sciences or other related scientific discipline. Minimum three (3) years of experience in a regulated industry with at least three (3) years of experience in pharmaceuticals and/or medical device, or equivalent. QMS experience. Imaging Core Lab and/or Contract Research Organization experience preferred. Knowledge and understanding of 21CFR Part 211, 21CFR Part 312, ISO 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 preferred

SENIOR REGULATORY AFFAIRS SPECIALIST

Regulatory Affairs Specialist coordinates and prioritizes work activities as delegated by Compliance and Regulatory Affairs Management. The RA Specialist reports results and updates to Compliance and Regulatory Affairs Management. Work with Compliance and Regulatory Affairs Management to develop robust processes and procedures. Prepare metrics and reporting to Compliance and Regulatory Affairs Management. The Regulatory Affairs Specialist adheres to QMS processes and procedures and provides training as necessary. Perform regulatory review and approval of Scientific, Clinical, QMS, and Regulatory documents. Reviews Project specific documentation (e.g., Image Review Charters, RPMPs, Interim and Final Reports). Performs regulatory review of Business proposals, RFIs, and other client facing documents. Understands and applies Imaging criteria assessments to support regulatory document reviews. Assists Compliance and Regulatory Affairs Management in coordination of work-related activities. Provide regulatory assistance within the regulations of investigational products and quality standards, including but not limited to 21 CFR Part 312, 314, 50, 54, 211, ICH E6(R2), Clinical Trials Imaging Endpoints Process Standards, GDPR, International GCP regulations, HIPAA, Risk Management, BIMO, and ISO 9001/13485. Interface with Scientific Affairs, Operations, and Clinical departments on regulatory issues, providing expertise and support as required. Assists in the development and management of IE’s Regulatory Intelligence Program. Assess current regulatory GCP trends in the industry and developing a process to identify, control, and maintain documents of external origin. Completes deviations, CAPAs, and other investigations with regulatory impact. Assists with creating and revising Regulatory, Clinical, and Scientific Standard Operating Procedures (SOPs). 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. Provide Regulatory training to IE personnel related to current industry practices and interpretation of FDA guidance, regulations, and standards. Assists the Compliance and Regulatory Affairs department in establishing and reporting quality and regulatory metrics. Develop SOPs and controls related to regulatory requirements as needed. 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.

EDUCATION AND EXPERIENCE

Bachelor’s degree a pharmaceutical sciences or other related scientific discipline. Minimum four (4) years of experience in a regulated industry with at least three (3) years of experience in pharmaceuticals and/or medical device, or equivalent. QMS experience. Imaging Core Lab and/or Contract Research Organization experience preferred. Knowledge and understanding of 21CFR Part 211, 21CFR Part 312, ISO 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 preferred

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 CureTM 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 and high ethical standards; we always do the right thing 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 REQUIREMENT

Estimated 5 – 10% travel (Domestic and International) #J-18808-Ljbffr Imperatrix Datum Solutions Corporation