• Lead, develop and support execution of PharmSci Audit strategic plan • Work in partnership with RQA on the internal audit plan • Analyze data to support audit and inspection management, regulatory compliance, and strategic planning • Ensure that the audit, inspection management and regulatory surveillance quality systems are a competitive advantage for PharmSci • Collaborate across the PharmSci network to standardize practices • Implement strategies for performance improvement and deploy metrics to determine effectiveness • Partner with PharmSci Business Lines, RQA and PGS to develop procedures and plans for audits, inspections and regulatory information management • Support the management of audit, inspection and regulatory information systems for PharmSci • Function as a Quality System Subject Matter Expert

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Form. • Responsible for/facilitates the translation and co-ordination of translations for documents. • Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF • May support the clinical team performing Pre-Study Site Visits.

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site • review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Form. • Responsible for/facilitates the translation and co-ordination of translations for documents. • Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF • May support the clinical team performing Pre-Study Site Visits.

Job Description Special Education Elementary focuses on K12-powered virtual elementary schools with personalized learning programs, engaging courses, compassionate teachers, and a vibrant school community. Responsible for program structure and resources to maximize the special education experience for both students and learning coaches. Responsible for relationship building with families, students, and learning coaches to ensures that all students are progressing successfully through the program. Bachelor’s degree, 0-1 year of related professional experienceSpecial Education Elementary focuses on K12-powered virtual elementary schools with personalized learning programs, engaging courses, compassionate teachers, and a vibrant school community. Responsible for program structure and resources to maximize the special education experience for both students and learning coaches. Responsible for relationship building with families, students, and learning coaches to ensures that all students are progressing successfully through the program. Bachelor’s degree, 0-1 year of related professional experience Required Certificates and Licenses: Missouri Special Education Teaching Certification Required Residency Requirements: Must reside in Missouri - This position is remote and strongly prefer candidates that reside in Missouri. The Special Education Teacher is a state certified teacher responsible for delivering specific course content in an online environment. The Special Education Teacher must provide instruction, support, and guidance, manage the learning process, and focus on students’ individual needs as defined by each student’s Individualized Education Program. The Special Education Teacher works actively with students and parents to advance each student’s learning and is also responsible for the compliance documents required in serving students with special needs. K12, a Stride Company, believes in Education for ANY ONE. We provide families with an online option for a high-quality, personalized education experience. Students can thrive, find their passion, and learn in an environment that encourages discovery at their own pace. Passionate Educators are needed at the Stride K12 partner school, Missouri Digital Academy (MODA). We want you to be a part of our talented team! The mission of Missouri Digital Academy (MODA) is to provide an exemplary individualized and engaging educational experience for students by incorporating school and community/family partnerships coupled with a rigorous curriculum along with a data-driven and student-centered instructional model. Student success will be measured by valid and reliable assessment data, parent and student satisfaction, and continued institutional growth within the academic community. Join us! This is a full-time position. Ability to work independently, typically 40+ hours per week is required. Ability to maintain a professional home office without distraction during workday, typically 9-5 (or 8-4) or as defined by the school. Essential Functions: Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties. - Ensure all special education and related services are provided as determined by the IEP team by: - Communicating with parents and applicable related service staff to ensure that students with special needs are receiving the appropriate therapies - Developing compliant IEP’s, progress reports and other state specific required special education documentation - Facilitating and leading collaborative special education meetings such as annual IEP meetings - Using provided resources to ensure accommodations and modifications for students with disabilities such as assistive technology, supplemental curriculum, and accessible text - Make modifications and accommodations to Stride K12 lessons and assessments as specified by the IEP - Ensure inclusion and success of student in the general education classroom - Collect data and work samples to monitor student progress towards Individual Education Program (IEP) goals and objectives - Document all contact with parents and interventions with students - Analyze student data to prescribe remediation and enrichment as needed - Provide rich and engaging synchronous and asynchronous learning experiences for students - Commitment to personalizing learning for all students - Demonstrate a belief in all students’ ability to succeed and meet high expectations - Maintain grade book ensuring student academic integrity, makes student placement and promotion decisions, and alerts administrators to concerns about student performance and progress - Prepare students for high stakes standardized tests - Understand that a primary responsibility is to establish and maintain positive rapport with families and regularly communicates with and responds to students and learning coaches/parents in a timely manner - Support learning coaches/parents with student curricular and instructional issues, as well as basic troubleshooting in a virtual classroom environment that is in line with academy policies and procedures - Ability to travel up to 20% of the time for face-to-face professional development, student testing, and/or as required by the school. MINIMUM REQUIRED QUALIFICATIONS: - Bachelor's degree AND - Active state teaching license AND - Ability to clear required background check OTHER REQUIRED QUALIFICATIONS: - Ability to work collaboratively with other teachers to interpret and produce numeric, tabular, and graphic representations of student data, and use it to drive instructional decisions - Receptive to receiving coaching on a regular basis with administrators - Ability to embrace change and adapt to ensure excellent student outcomes - Proficient in Microsoft Excel, Outlook, Word; PowerPoint - Ability to rapidly learn and adapt to new technologies and teaching platforms - Strong written/verbal communication skills DESIRED QUALIFICATIONS: - Experience working with the proposed age group - Experience supporting adults and children in the use of technology - Experience teaching online (virtual) and/or in a brick-and-mortar environment - Experience with online learning platform Compensation & Benefits: Stride, Inc. considers a person’s education, experience, and qualifications, as well as the position’s work location, expected quality and quantity of work, required travel (if any), external market and internal value when determining a new employee’s salary level. Salaries will differ based on these factors, the position’s level and expected contribution, and the employee’s benefits elections. Offers will typically be in the bottom half of the range. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - This position is virtual Job Type Regular The above job is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. All employment is “at-will” as governed by the law of the state where the employee works. It is further understood that the “at-will” nature of employment is one aspect of employment that cannot be changed except in writing and signed by an authorized officer. If you are a job seeker with a disability and require a reasonable accommodation to apply for one of our jobs, you can request the appropriate accommodation by contacting stridecareers@k12.com. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities Stride, Inc. is an equal opportunity employer. Applicants receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status, or any other basis prohibited by federal, state, or local law. Stride, Inc. complies with all legally required affirmative action obligations. Applicants will not be discriminated against because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.