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Requisition: ES Title: Director of Operations - Proposals and Submissions FLSA status: Exempt Hiring Salary: Commensurate with education and experience. Department: Office of Research & Sponsored Programs (ORSP) Division: Division of Academic Affairs Open Date: 09/16/2025 Open Until Filled: Yes Educational and Experience Requirement: Bachelor's degree in a related field. Five years full-time professional experience at an educational institution or related experience. Preference will be given to candidates with either a Certified Research Administrator (CRA ), or Certified Pre-Award Research Administrator (CPRA ) certificate. Experience and demonstrated success in managing staff and resources preferred. Additional education may be considered in lieu of experience. Nature & Purpose of Position: Performs as the Director of Submissions and Awards for the Office of Research and Sponsored Programs (ORSP) in all phases of departmental operations. Provides control of grants management and budget development in terms of sponsor requirements. Develops, implements, and trains university faculty and staff on standard operational policies to ensure fiscal accountability and operational excellence. Creates synergy, tools, resources, and seamless processes among the Submissions and Awards unit, the Research and Proposal Development unit, and the Office of Research Administration to curate a top-tier experience for campus researchers. Primary Responsibilities: Directs day-to-day operations of proposal submissions and award staff. Responsible for organizing, planning, and evaluating personnel, work assignments, supervision, training, and technical direction of staff. Maintains an on-line platform for grant development, and routing, submissions, and awards. Develops strategies and processes to optimize operations for the department. Develops, documents, and implements internal control procedures and standard operating procedures (SOPs) to ensure fiscal, regulatory, confidentiality, and security accountability. Coordinates and oversees the development of all grants from notification through submission. Develops and coordinates training on SOPs for university faculty and staff. Gives presentations and provides training to staff and faculty of the university. Develops financial and grants submission policies and procedures in accordance with national research administration standards. Develops and tracks proposals for institutional reporting. Performs other related duties as assigned. Other Specifications: Requires exceptional interpersonal skills to work with Faculty, Deans, Senior Administration, Sponsors and other key contacts. Demonstrates knowledge and understanding of research administration information systems. Requires exceptional written and oral communication skills along with attention to detail and strong organizational and time-management skills. Interprets and applies complex directives, policies, regulations, statues, and procedures. This position may be designated as a Campus Security Authority (CSA). Full Time Part Time: Full Time Quicklink: EEO Statement: Sam Houston State University is an Equal Employment Opportunity Employer and Smoke/Drug-Free Workplace. All qualified applicants will receive consideration for employment without regard to race, creed, ancestry, marital status, citizenship, color, national origin, sex, religion, age, disability, or protected veteran status. The University takes seriously the initiative to ensure equal opportunity in the workforce and to comply with Title VII as interpreted by the U.S. Supreme Court. Sam Houston State University is an "at will" employer. Employees with a contract will have additional terms and conditions. Security-sensitive positions at SHSU require background checks in accordance with Education Code 51.215. Annual Security and Fire Safety Report

The Center for Elders' Independence is a PACE (Program of All-Inclusive Care for the elderly) organization (PO) that uses an interdisciplinary team approach for care planning and implementing purposeful high quality, affordable, and integrated health care services to the elderly. Our elderly meet PACE requirements as prescribed by CMS and are referred to as participants. Our PO includes Adult Day Health Centers and primary care clinics, promoting participant autonomy, quality of life and the ability for individuals to live in their communities THE POS I TION : The Director of Regulatory Affairs will develop and execute healthcare policy analysis and s trategic oversight of CEI's regulatory strategy to ensure compliance with federal and California PACE requirements ( Centers for Medicare & Medicaid Services (CMS) and California Department of Health Care Services (DHCS) ). This D irector provides strategic guidance, supports compliance program management, and serves as the primary liaison with government agencies, particularly CMS and DHCS . This leader will manage regulatory submissions, guide cross functional teams through complex healthcare policy and regulatory matters, and support audits, inspections, and ongoing regulatory reporting. The role requires deep experience with healthcare policy , PACE federal and state regulatory frameworks, strong project and stakeholder management skills, and proven leadership in healthcare regulatory/compliance environments . DUTIES AND RESPONSIBILITIES: Regulatory Affairs : Develop and implement regulatory strategies that support CEI's PACE program growth and ongoing compliance with CMS and DHCS requirements. Act as the primary point of contact for CMS and state agencies , which involves managing relationships, responding to inquiries, and representing the PACE organization during audits or investigations . Lead preparation, submission, tracking, and maintenance of PACE applications, amendments, notices, and other regulatory filings to CMS and DHCS. Partner with legal counsel, external compliance consultants, and the Compliance Officer to coordinate filings, audits, and regulatory responses. Policy I nterpretation and S trategy: Monitor, interpret and communicate new federal and state regulations, policy changes, and guidance documents to determine their impact on PACE operations. Assess operational impact and develop and communicate a regulatory strategy to senior leadership to implement required changes. Compliance P rogram M anagement : Implement and m onitor effective compliance program elements . C reat e policies and procedures, ensur e annual risk assessments are performed, and manag e an annual auditing plan s . Risk A ssessment and M itigation: Identify and assess potential compliance risks and develop strategies to mitigate them. This includes resolving any instances of non-compliance and implementing corrective action plans. Conduct regulatory risk assessments; identify, escalate, and mitigate regulatory risks in collaboration with the General Counsel, Compliance Officer, and operational leaders. Review marketing and promotional materials for regulatory compliance. Oversee annual compliance reviews, audits, testing, and monitoring of internal controls related to PACE operations and regulatory filings. Process Improvement: Design, enhance, and maintain compliance workflows, systems, and internal controls to support efficient regulatory operations . Represent CEI on multidisciplinary continuous improvement projects and ensure regulatory perspectives are integrated into organizational strategy Training and E ducation: Draft, update, and maintain policies, procedures, and guidance documents; provide regulatory education across departments. Create and deliver training programs to ensure all staff and contractors understand and comply with regulatory requirements. This fosters a culture of compliance throughout the organization. QUALIFICATIONS : Deep, working knowledge of healthcare policy, PACE federal and state regulatory frameworks, including CMS and DHCS requirements. 15+ years of progressive experience in healthcare policy analysis, regulatory affairs, compliance, and PACE operations - including direct experience working with or responding to CMS and/or DHCS. Master's degree in Healthcare Administration, Regulatory Affairs, Public Health, Juris Doctorate, or a related field (or equivalent experience). Proven ability to lead cross-functional teams and manage enterprise-level regulatory programs. Training leader, facilitator and mentor on Kaizen, A3 and data collection processes. Strong written and verbal The above job description is intended to communicate the general function of the mentioned position and by no means shall be considered an exhaustive or complete outline of the specific tasks and functions that will be required. CEI reserves the right to change job descriptions, site assignments, and or work hours as required by the needs of the program. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management. Center for Elders' Independence is a PACE (Program of All- Inclusive Care for the Elderly) organization that uses an interdisciplinary team approach to care planning and care implementation for the purpose of providing high quality, affordable, integrated health care services to the elderly, including an Adult Day Health Center, and promoting autonomy, quality of life and the ability of individuals to live in their communities. Unlike other healthcare plans, CEI is not a "fee-for-service" plan. It is a "capitation" healthcare plan. CEI is paid a set amount for each person enrolled in our program, whether or not that individual seeks care. We are a growing company that offers stability and continues to thrive.

SUMMARY The Administrator is responsible for the overall daily management and operation of the clinic. The Administrator reports directly to first line regional operational management which may be an Area Director, Regional Director, or Vice President of Operations, depending on the region/demographics. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties and tasks may be assigned. GROWTH Develop and implement processes for program growth in accordance with Company goals. Plan/coordinate patient scheduling to assure timely acceptance of patients and effective staffing levels. Implement clinical and operational processes to improve patient health and minimize hospitalizations and missed treatments. Achieve financial targets to include budget, labor costs, supply costs and expenditures. OUTCOMES Review all incident reports; make recommendations and take action relative to incidents as appropriate; report at monthly QAPI meeting. Promote quality management program through education and involvement of staff and patients in outcomes as well as overall responsibility to achieve corporate goals for quality. Leads QAPI meetings and quality improvement committees. Coordinate the functions of all departments and develop standards and methods of measuring patient care services, including a chronological record of services provided to patients as required by the ESRD Network Coordinating Council and Medicare. Work with staff to maintain chronological, thorough, and appropriate documentation in the patient record of all treatments, activities, and communication with the patient, physician and other healthcare professionals. Achieve program's target goals for patient outcomes in accordance with quality patient care and Company goals. OPERATIONAL READINESS Knowledge of and remain current with federal, state, local laws and regulations, including health care professionals practice act requirements. Assure that the clinic is in compliance with all applicable federal, state, and local laws and regulations and receives continuing certification from all statutory and regulatory agencies. Develop, implement and follow up necessary Corrective Action Plans for internal and external surveys. May assume Charge Nurse's responsibilities as needed. Responsible for duties listed in Registered Supervising Nurse job description and nursing services policy # C-AD-0110 or must designate Registered Nurse meeting these qualifications. May fulfill responsibility of facility CEO as delegated by Governing Body. Conduct and/or participate in both formal and informal meetings with the governing body, Regional Director, Medical Director and the staff. Assure that appropriate staff meetings, in-service education meetings, and team patient care planning meetings are held monthly. Assure that Quality Assessment & Performance Improvement Program is current at all times. Establish, maintain, and submit all required records and reports concerning staff, patients, and the operational affairs of the center. Plan, coordinate, and approve effective and efficient staffing to meet patient needs and regulations. Oversee the maintenance of equipment and supplies to meet current laws and regulations. OPERATIONAL READINESS (cont.) Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly. Supervise the maintenance of equipment, building areas occupied by the center and other property belonging to the center. Know and understand the water treatment and mechanisms of the equipment of the facility. Assist, when necessary, with disinfection of equipment and supplies including bicarbonate delivery systems and dialysis machines. PARTNERSHIPS Monitor all contractual agreements; update as needed with corporate oversight. Maintain collaborative working relationship with Medical Director and physicians. Establish and maintain a positive relationship with area hospitals, agencies, vendors and the community. Actively promote GUEST customer service standards; develop effective relationships at all levels of the organization. Respond effectively to inquiries or complaints. STAFF DEVELOPMENT/ RETENTION Ensure all staff meet required qualifications for position held and perform duties within limitations established by and in accordance with company policy/procedures, health care professionals practice acts, applicable state and federal laws and regulations. Recruit, train, develop, and supervise all personnel. Maintain effective personnel management and employee relations, including evaluating the performance of all personnel; approving and submitting all hours worked and counseling and disciplining employees. Uphold management goals of corporation by leading staff in team concepts and promoting a team effort. Effectively communicates expectations; accepts accountability and holds others accountable for performance. Qualifications/Requirements: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Requirements include: Demonstrated ability to function in a leadership position and to perform in new and emergent situations with sound judgment. Demonstrated analytical and problem-solving skills are required. Strong time management and organizational skills required. 1 year previous dialysis management experience preferred. Demonstrated working knowledge of the English language and ability to communicate verbally and in writing. Must have basic computer skills, including Microsoft Office (Word, Excel, Outlook); proficiency in all USRC clinical applications required within 90 days of hire. Must meet applicable, specific state requirements. (See addendum for Administrator. Additionally, if the nursing requirements listed below are not met, an individual may be placed in the Administrator role without them; however, in the absence of these qualifications, there must be a designated Registered Supervising Nurse at the clinic who does possess these qualifications: Must be full-time employee of the Company and available to clinic staff during time clinic is open. Current RN license in applicable state. License must be maintained as current and in good standing. 18 months as an RN with 6 months experience in nursing care of a patient with kidney failure. CPR certification required within 90 days of hire. Confirmation of ability to distinguish all primary colors. Must meet any practice requirement(s) for the applicable state. (See addendum for Registered Supervising Nurse) All Full Time employees are eligible for the following benefits: Medical / Pharmacy Dental Vision Voluntary benefits 401k with employer match Virtual Care Life Insurance Voluntary Benefits PTO All Part Time employees are eligible for the following benefits: 401k with employer match PTO

The Associate Dean for Portfolio Planning & Evaluation provides strategic, data-informed leadership for the planning, evaluation, and continuous improvement of academic programs within an assigned portfolio. Reporting to the Senior Associate Dean, this role serves as the portfolio's chief architect of programmatic relevance, quality assurance, and long-term sustainability, guiding the lifecycle of academic programs. The Associate Dean ensures academic offerings are aligned with institutional strategy, workforce demand, and learner success metrics through the oversight of strategic planning, program review, resource allocation, and performance evaluation. The role also provides direction and supervision to Assistant Deans, Portfolio Directors, Portfolio Managers, and Teaching & Learning Faculty to ensure forward-looking, high-functioning operations and consistent academic standards. Success in this position is measured by the ability to drive programmatic excellence, lead effective planning cycles, cultivate high-performing teams and ensure the ongoing relevance and quality of learning experiences across the portfolio, while remaining responsive to an evolving educational and workforce landscape. Key Duties and Responsibilities: Lead the strategic planning and evaluation of assigned academic programs, in the Marketing, Management, and Health Care Administration department, ensuring alignment with institutional priorities and evolving market needs. Use data, labor market intelligence, and institutional strategy to identify growth opportunities and enhancements for long-term impact. Direct the academic program review process, use data and stakeholder input to conduct evidence-based assessment of program viability, identify improvement opportunities, and ensure compliance with accreditation and learner success standards. Make informed recommendations on program lifecycle decisions (e.g., launch, revision, suspension, or sunset) to the Senior Associate Dean based on strategic fit and performance metrics. Oversee the implementation of quality assurance processes, including curriculum reviews, faculty evaluations, and learner experience assessments. Collaborate with the Senior Associate Dean to elevate quality standards and inform operational priorities. Allocate full-time faculty and staff resources strategically across the portfolio to meet academic needs, balance workloads, and support institutional growth. Supervise and mentor Assistant Deans, Portfolio Directors, Teaching & Learning Faculty, and Portfolio Managers to ensure coordinated execution and continuous leadership development in the design and delivery of programs. Interpret and act upon student success data (e.g., persistence, retention, graduation rates) to implement academic interventions and drive improvements in learner outcomes. Collaborate with curriculum and academic operations units to guide program design, course development, and delivery innovations that enhance teaching and learning. Advocate for innovations that improve engagement and learner outcomes. Support accreditation, compliance, and institutional effectiveness initiatives by ensuring data integrity and adherence to internal and external standards. Perform other duties as assigned by the Senior Associate Dean, including supporting the Senior Associate Dean on cross-portfolio initiatives and special academic projects that strengthen program performance or stakeholder engagement. Competencies: Strategic academic planning and evaluation Program lifecycle management. Leadership and staff supervision Academic quality assurance and improvement Data-driven decision making Faculty development and mentorship Stakeholder engagement and collaboration Skills: Academic program review and analysis Data interpretation and visualization Supervisory and team development skills Strategic resource planning and allocation Curriculum and instructional planning Communication and report writing Change management and systems thinking. Key Collaborators: Senior Associate Dean: To align strategic planning and resource allocation decisions with broader academic operations and institutional priorities. Assistant Deans and Portfolio Directors: To guide implementation of planning and evaluation efforts and ensure coordinated execution across academic units. Portfolio Managers and Teaching & Learning Faculty: To provide oversight, coaching, and clarity around academic expectations, evaluation standards, and learner experience goals. Curriculum Governance Committees: To review and approve program revisions, new program proposals, and sunset recommendations. Center for Institutional Effectiveness and Analytics: To interpret student success metrics and translate insights into actionable academic improvements. Faculty Affairs & Scheduling Team (FAST) and Human Resources: To support full-time faculty staffing plans, development needs, and performance improvement strategies. External Stakeholders (e.g., accreditation bodies, industry advisory boards): To ensure programs meet workforce needs and maintain compliance with professional and regulatory expectations. Minimum Education & Experience Requirements: Education: Doctorate in Business, Business Administration, or Management from a Business School or College at an accredited institution; in a portfolio-related discipline is highly preferred. Experience: Demonstrated ability to get things done. Minimum of 5 years of academic leadership experience in higher education, including program management and faculty leadership. Preferred Education & Experience Requirements: Education: Same as required Experience: Demonstrated experience collaborating with external partners such as industry, professional associations, or community organizations. Work environment and physical demands: Work is typically performed in an office or a hybrid academic setting. Must be able to analyze large sets of data, manage competing academic priorities, and collaborate across a distributed leadership structure. Residence in or relocation to the Maryland/Washington, D.C./Northern Virginia metro area is required. All submissions should include a cover letter and resume. The University of Maryland Global Campus (UMGC) is an equal opportunity employer and complies with all applicable federal and state laws regarding nondiscrimination. UMGC is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, ancestry, political affiliation or veteran status in employment, educational programs and activities, and admissions. Workplace Accommodations: The University of Maryland Global Campus Global Campus (UMGC) is committed to creating and maintaining a welcoming and inclusive working environment for people of all abilities. UMGC is dedicated to the principle that no qualified individual with a disability shall, based on disability, be excluded from participation in or be denied the benefits of the services, programs, or activities of the University, or be subjected to discrimination. For information about UMGC's Reasonable Workplace Accommodation Policy or to request an accommodation, applicants/candidates can contact Employee Accommodations via email at . Benefits Package Highlights: Generous Time Off: Enjoy 22 days of paid vacation, 15 days of sick leave, 3 personal days, and 15 paid holidays (16 during general election years). For part-time employees, time off rates will be prorated based on the number of hours worked. Comprehensive Health Coverage: Access to health care, medical with vision, dental, and prescription plans for both individuals and families, effective from the 1st of the month following your hire date. Insurance Options: Term Life Insurance, Accidental Death and Dismemberment Insurance, and Long-Term Disability (LTD) Insurance. Part-time employees working less than 0.5 FTE are not eligible for LTD. Flexible Spending Accounts: Available for medical and dependent care expenses. Retirement Plans: Choose between the Optional Retirement Program (ORP) or the Maryland State Retirement and Pension System (MSRPS). Supplemental Retirement Plans: include 401(k), 403(b), 457(b), and various Roth options. The university does not provide matching funds. Tuition Remission: Immediate availability for Regular Exempt Staff. Spouses and dependent children are eligible for undergraduate tuition remission after two years of service. NOTE: For part-time employees (at least 50 percent of the time), tuition remission benefits are prorated.

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: The primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of multiple projects within Daiichi Sankyo's Oncology Late-Stage Development Portfolio. The individual will play a key role in making Precision Medicine a reality for patients who are likely to benefit from our therapeutics. Responsibilities: Acts as CDx representative to the Global Project Team (GPT) for any projects that definitively require a CDx for drug registration or for any project with CDPs containing multiple registrational clinical trials and are extensively exploring the predictive nature of potential CDx assays.Leads CDx project teams for the diagnostic, in full alignment with Global Project Teams (GPT) covering all areas from CDx assay development through CDx approval and launch. Creates the CDx development strategy, including partner evaluation and selection for a registrational phase project.Manages CDx development activities and deliverables in collaboration with diagnostic partner across all clinical trials within the project, including the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx submission strategies.May represent DS in various Health Authority interactions for the drug trials or for approval of CDx.Keeps abreast of regulatory and policy updates in the external environment and understands the competitive landscape.Proactively shifts CDx strategy to account for external shifts. Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs, and in support of pre-launch, launch and LCM activities as necessary. Direct line management responsibility including developing and mentoring of Managers, Associate Directors and Directors. May serve on CDx department extended leadership team. Qualifications: (What are the minimum requirements for the position?) Education: PhD, MD or PharmD - minimum of 12 years' experience or MS - minimum of 15 years of experience or BS/BA - minimum of 19 years of experience required Experience: Demonstrated track record of success working on multidisciplinary, international pharmaceutical development teams Experience with CDx regulatory submissions to the FDA and other health authorities globally. At least 4 years of companion diagnostic development experience within a pharmaceutical company. At least 2 years of experience managing direct reports. Competencies: Ability to lead in a highly collaborative global environment with stakeholders from multiple functional areas Strong strategic leadership skills with an ability to define, prioritize and balance team responsibilities in accordance with business and team needs Strong interpersonal and verbal and written communication skills with the ability to effectively communicate within project teams, both internal teams and alliance partner teams, and with all levels of management, including senior management, across various functions and locations Broad knowledge and understanding of established and new assay technologies.Ability to strategically think about how to incorporate new technologies into the drug development process. Knowledge of drug development process and an understanding of how diagnostic development can shape drug development and commercialization. Ability to navigate evolving CDx-relevant regulatory guidelines and provide guidance and mentorship to junior CDx members. Ability to influence without authority within the organization. Ability to inspire and to lead direct reports. Travel: Domestic and international may be required: 15% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Salary Range: $230,175.00 - $383,625.00Download Our Benefits Summary PDF

Category:: Full-time Staff Subscribe:: Department:: Academic Affairs - Health Locations:: Lowell, MA Posted:: Oct 23, 2024 Closes:: Nov 6, 2025 - 11:59 PM EST Type:: Full-time Position ID:: 182380 About Middlesex Community College: Middlesex Community College (MCC), established in 1970, provides access to affordable education to prepare individuals for success and lifelong learning. We promote academic excellence, provide workforce development opportunities, and empower all learners to become productive and socially responsible members of our local and global communities. The College provides a broad range of services that are essential to attract, reward, and retain talented faculty and staff. The MCC community promotes a work environment where our employees feel supported and empowered to best serve our student population. We are proud to offer our classes on both the Bedford and Lowell campuses, as well as a robust online course offering. MCC is committed to transforming lives as we educate, challenge, and support all students as evident in our strategic plan . Job Description: Title: Director of Practical Nurse Education Unit: Non-Unit Professional ( NUP ) Department: Nursing Reports to: Senior Director of Nurse Education Date: October 28, 2024 (Reopened September 25, 2025) General Summary: The Director of Practical Nurse Education is a 12-month position, responsible for serving as administrator of record for the Practical Nursing program. The Director of Practical Nurse Education collaborates with the Senior Director of Nurse Education in establishing, maintaining, and monitoring current and sound educational practices. The Director or Practical Nurse Education provides strategic leadership for the Practical Nursing Program and serves as the administrative representative to state and federal regulatory authorities, accrediting bodies, and to pertinent professional nursing associations. The Director is responsible to students, faculty, and college administration for the safe and lawful operations of the Practical Nursing program. This includes management of the Practical Nursing Program budget, related grant budgets, maintenance and development of the Program Advisory Board meetings, and maintenance of program accreditations. This essential role encompasses collaborating with all nursing program faculty, support staff, the Senior Director of Nursing Education, and the Dean of Health to ensure continuous Practical Nursing Program improvement and alignment with the ADN program. The position requires an equity-minded, creative, and knowledgeable individual with a positive approach to program management, and a with a mindset that supports the college's strategic initiatives. The Director of Practical Nurse Education is expected to exhibit initiative, enthusiasm, and teamwork in accomplishing the responsibilities of the position. The individual who serves in this position must be committed to equity, diversity, excellence, student engagement, and success. Duties and Responsibilities: Provide academic leadership and administrative direction to the Practical Nursing Program by: Serving as the Nurse Administrator/Administrator of Record in accordance with the Massachusetts Board of Registration in Nursing and accreditation requirements for Practical Nursing Program. Overseeing planning, implementation, and evaluation of all aspects of the educational programs, including curriculum development and the nursing program systematic evaluation plan. Coordinating searches for full-time faculty and staff positions for the Practical Nursing Programs. Orienting, mentor and evaluate full-time and part-time faculty in their areas of responsibility according to the MCCC contract for Practical Nursing Program. Recruiting, interview and hire full-time and part-time faculty for Practical Nursing Programs. Preparing schedules and payroll for adjunct faculty for submission to the Dean of Health for the Practical Nursing Program. Planning and managing the budget to ensure the acquisition of necessary equipment and supplies for classrooms, laboratories and other instructional settings. Determine priorities for budgetary expenditures based on department needs; monitor budget. Developing schedules for all classes offered in the Practical Nursing Program. Preparing reports as needed for regulatory agencies, the College, and to support Nursing program initiatives and to assess the effectiveness of initiatives. Ensuring compliance with all required state regulations and accreditation criteria. Promoting and maintain responsive community relations, including a Nursing Department Advisory Board that meets at least 2 times per year. Resolving student issues as they relate to the Practical Nursing Program. Developing and renew articulation agreements with area high schools, ADN programs, and four-year institutions as appropriate. Encouraging and structure innovative professional development activities. Providing leadership and direction to faculty in development of initiatives and activities that promote positive program outcomes. Providing guidance and leadership to faculty on the use of alternative pedagogy to enhance student learning. This includes the promotion of instructional applications of technology, web-based enhancements, and e-learning. Developing and implement grants and support faculty in developing and implementing grants. Working in collaboration with relevant areas of the college to ensure that all students in the Nursing program receive appropriate academic advising. Working in collaboration with coordinators of the Nursing Program options. Participating in relevant committees of the College. Collaborate with the Senior Director of Nurse Education and Dean of Health to: Develop, implement, and assess Practical Nursing Department goals. Ensure that goals align with the institution's mission and values and support the college's strategic directions including student success initiatives. Provide leadership in grant activities for the Nursing Department. Assist with data collection, analysis and reporting. Assess programmatic needs through the program review process and oversee the assessment of institutional, departmental and course student learning outcomes. Develop and improve departmental curriculum which includes the development, revision, implementation and/or removal of courses. Maintain current knowledge of trends and practices in the field through peer association, attendance at seminars, study, and review of literature. Other duties as needed or assigned. Requirements: Maintains compliance with of Massachusetts Board of Regulations in Nursing 244 CMR 6.04(2)(a); Holds a Massachusetts Registered Nurse license in good standing Possesses an earned graduate degree in nursing Possesses a minimum of five years full-time nursing experience with at least three years full-time experience, or its equivalent, in nursing education in either: a nursing education program designed to prepare a graduate to practice as a Licensed Practical Nurse or a Registered Nurse; or a post-licensure graduate nursing education program Develops and maintains competence appropriate to administrative responsibilities including, but not limited to: orientation and mentoring to the administrator role; knowledge of M.G.L. c. 112, 74 through 81C and 244 CMR Participates in professional development in nursing education such as certification, continuing education Develops knowledge of nursing and college administration Experience working as a Practical Nurse and/or clear understanding of Practical Nursing scope of practice Maintains a commitment to the mission and philosophy of the college with an understanding and respect for the goals of college activities. Leadership, planning, management, and supervisory skills. Strong organizational skills. Ability to recognize college-wide priorities and work cooperatively and collaboratively to support their accomplishment. Financial management skills. Ability to market programs and ideas; to communicate effectively both verbally and in writing; to establish positive public relations, and to work collaboratively with people to set and achieve common goals. Knowledge of curriculum development, including theory and practice. Knowledge of nursing education and program assessment. Understanding of the need to incorporate technology into the many aspects of the college. Experience with equity-minded work and/or understanding of individuals of diverse identities such as race, ethnicity, socioeconomic level, sexual orientation, veterans, and individuals with different academic preparation levels and varying physical and learning abilities. Preferred Qualifications: Understanding of and commitment to the role of the community college in higher education. Knowledge of cultural competency skills framework. Bilingual skills a plus. Additional Information: Salary Range: $105,000 - $115,000; actual salary commensurate with academic background and experience. Employees of Middlesex Community College are considered employees of the Commonwealth of Massachusetts and receive benefits, which include: . click apply for full job details

Associate Vice President, Division of Sponsored Programs Administration Job ID: 278110 Location: Augusta University Full/Part Time: Full Time Regular/Temporary: Job Summary The Associate Vice President, Division of Sponsored Programs Administration will report directly to the Senior Vice President for Research and be an integral and vital part of the university's leadership team. The Associate Vice President will be responsible for providing positive leadership, support, and strategic direction for all sponsored programs administration activities. The Division of Sponsored Programs Administration and the Augusta University Research Institute serves as the central unit to coordinate and support Augusta University's internal and external sponsored projects. The Division has four units: Pre-Award, Contracts, Operations, and Post-Award. The Division aims to identify, support, and advance opportunities for research, training, teaching, and scholarly activities by managing the entire lifecycle of sponsored projects- from proposal and grant development and submission, to contract preparation, award management, and project close out management. The DSPA seeks to advance extramural support programs for the institution by providing administrative, informational, and logistical assistance to faculty and staff, while ensuring compliance with pertinent policies and regulations of the institution, extramural sponsors, and federal oversight agencies. This position is considered an administrative officer and serves at the pleasure of the president. Responsibilities Administrative & Financial Functions - 50% Oversees daily administration of the Division of Sponsored Programs Administration, oversight of all Sponsored Program activities, development of effective administrative compliance procedures, assurance of proper resource allocation, identifying funding sources, funding acquisition, regulatory compliance, recordkeeping, and systems for all grants and awards. As Executive Director for AURI, the incumbent will develop, oversee, and manage the AURI accounts, expenses, and budgets ensuring that the following: Preparation and completion of quarterly reports and annual summaries. Preparation of annual budget and planned development Investment opportunities. Provision of support for annual external audit processes. Management and oversight for all expenses, investments, and acquisitions. Oversee the complete life-cycle of sponsored programs administration including but not limited to: Pre-award responsibilities for coordination, review and approval of documents requiring institutional/administrative approval. All regulatory and compliance office requirements as required by law, policy, or agreement/grant/contract have been met Award receipt and account establishment, expense monitoring, re-budgeting Account Closeout activities Development of reports to ensure compliance with requirements of sponsors, local, state, or federal sponsors/agencies Effort reporting. Development and negotiation of AU's federal Facilities and Administrative Cost Rate Agreement. Maintains and expands research/contract opportunities and provides on-going support for the development of grants and contract opportunities. Management & Leadership - 25% Provide leadership, direction, and management of all staff and activities within the Division of Sponsored Programs Administration ensuring that all contractual and financial obligations are managed and compliant with institutional, state, and federal regulations. Responsible for the overall direction and effective management of the Division of Sponsored, Programs Administration including, hiring, training, supporting, developing and supervising personnel. Allocate workload to maximize Division effectiveness Facilitate professional growth of staff by accurately assessing learning needs, styles, and barriers to learning and coordinating learning opportunities for staff. Provide opportunities for ongoing professional development for self and staff while maintaining a collegial working environment. Work collaboratively with internal and external constituents such as vice presidents, deans, faculty, etc. in the development and implementation of AU goals and objectives Participate in AU committees and meetings . Represent AU at local, state, and national meetings pertaining to sponsored projects . Policy Development & Strategic Planning - 20% Serve as a resource for AU investigators and leaders ensuring that they have the information needed to effectively and compliantly obtain, manage, and close grants and contracts. Work collaboratively with the University's Office of Legal Affairs to ensure efficient, effective, and compliant contract review and approval processes, and appropriate delegation where appropriate. Develop policies and procedures for process improvements and metrics for reporting improvements in all aspects of Division of Sponsored Programs Administration activities and programs. Understand and disseminate information pertaining to local, state, and federal regulations as they relate to sponsored program administration. Create and implement an approved strategic plan to leverage the existing infrastructure while identifying opportunities for further growth and expansion of research programs at AU. Develop institutional policies to be consistent with USG, state. and federal guidelines. Other - 5% Other duties as assigned Required Qualifications Educational Requirements Master's degree or equivalent Preferred Qualifications Doctorate degree A Certified Public Accountant (CPA) license and a Law degree are also preferred. (It is noted the incumbent will NOT be functioning as an attorney or paralegal.) The ideal candidate will have 10+ years combined experience in financial management, sponsored programs administration, contract negotiations, and research program administration. Shift/Salary/Benefits This position is fiscal year based and works year-round. The intended work commitment or full-time equivalent (FTE) for this position is 1.0 and considered full-time. Salary and compensation is commensurate with education, experience, and achievements. The salary is subject to availability of funds. Comprehensive benefits include medical, dental, vision, 13 paid holidays, vacation leave, sick leave, generous retirement plans, tuition waiver, wellness options, and much more! Also, our full-time employees who have been employed with us successfully for more than 6 months can be considered for the Tuition Assistance Program. Rank and salary are determined at the time of hire and are based on a variety of factors including but not limited to experience, education, credentials, specialty, training, etc. while also considering internal equity and market data. Advancement through the faculty ranks at Augusta University is only through the annual Promotion and Tenure process in which faculty may apply if eligible (typically five-year increments). For more information on ranks, please review the Augusta University Promotion and Tenure Website: About Us Augusta University is Georgia's innovation center for education and health care, training the next generation of innovators, leaders, and healthcare providers in classrooms and clinics on four campuses in Augusta and locations across the state. More than 10,500 students choose Augusta for educational opportunities at the center of Georgia's cybersecurity hub and experiential learning that blends arts and application, humanities, and the health sciences. Augusta is home to Georgia's only public academic health center, where groundbreaking research is creating a healthier, more prosperous Georgia, and world-class clinicians are bringing the medicine of tomorrow to patient care today. Our mission and values make Augusta University an institution like no other. The University System of Georgia is comprised of our 26 institutions of higher education and learning as well as the System Office. Our USG Statement of Core Values are Integrity, Excellence, Accountability, and Respect. These values serve as the foundation for all that we do as an organization, and each USG community member is responsible for demonstrating and upholding these standards. More details on the USG Statement of Core Values and Code of Conduct are available in USG Board Policy 8.2.18.1.2 and can be found online at Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found online at . Location Augusta University - Our Health Sciences Campus: th Street, Augusta, GA 30912 Our Summerville Campus: 2500 Walton Way, Augusta, GA 30904 Conditions of Employment All selected candidates are required to successfully pass a Background Check review prior to starting with Augusta University. If applicable for the specific position based on the duties: the candidate will also need to have a credit check completed for Positions of Trust and/or approved departmental Purchase Card usage. Motor vehicle reports are required for positions that are required to drive an Augusta University vehicle. . click apply for full job details

Reporting to the Co-President, plans, organizes, and directs the campus operations in accordance with all applicable regulatory/governmental/accreditation standards within the proprietary education sector. Provides leadership in the interpretation, coordination, and administration of the policies and procedures on student enrollments, financial aid, student aid, student retention, career services and placements, educational/support staff and personnel administration. Oversees, directs and manages the Campus operations, budget and performance objectives personally or through subordinate managers to ensure the campus meets University goals. Serves as a member of the University Leadership Council for strategic planning, fiscal management, resource development, community relations, and policy setting. Assists in the development of operational and capital budgets and prepares reports on campus services, enrollments, placements, and training budgets, staffing, and other activities as required. Essential Functions & Responsibilities: Oversees and directs the development and administration of the campus annual plan. Coordinates the development of the annual campus budget; supervises expenditures and maintains fiscal control. Oversees the development and execution of campus-based strategic initiatives for co-curricular services, staff development, and facilities. Ensures campus delivers appropriate academic and co-curricular support services fostering student success. Provides administrative leadership to carry out the effective and efficient operations of the campus. Implements policies and practices which reflect the integrity of the institution and fosters public trust. Collaborates with other University leaders in pursuit of the University's goals and objectives. Serves on planning and policy-making committees. Manages the selection, evaluation, development and assignment of administrative associates. Meets or exceeds University standards for student satisfaction, retention, completion, and placement rates. Ensures campus achieves all budgeted profit and loss metrics. Collaborates with, and ensures campus associates collaborate with, Shared Services and University Administration in effectively achieving campus outcomes. Ensures the Fire, Safety and Emergency Plan is maintained, kept up to date and administered efficiently for the campus. Ensures the campus facility is functionally and aesthetically maintained. Initiates external partnerships and collaborations that serve the community and involves the community with the campus. Represents the University externally to media, regulatory agencies, funding agencies, and the general public as appropriate. Participates in professional development and organizations in order to maintain an understanding of current ideas, research and practices. Attends meetings, workshops and seminars to enrich personal growth, knowledge and leadership skills. Maintains professional appearance for position and serves as a role model, leader and mentor to the campus community. Adheres to University policies and procedures and provides leadership to all associates through guidance and example. Conducts job responsibilities in accordance with the standards set out in the University's Code of Ethical Conduct, Compliance Agreement, Sexual Harassment Policy or any of its policies and procedures, applicable federal and states laws, and applicable professional standards. Performs other job duties as assigned. Minimum & Preferred Qualifications: Required: Bachelor's degree in education, administration, business management, student affairs, or related field required. Preferred: Master's degree in education, administration, business management, student affairs, or related field strongly preferred. Terminal degree with major study in education, administration, business management, student affairs, or related field preferred. Experience & Skills: Required: A minimum of three years in a senior administrative level position within appropriate/equivalent industry concerned with academic and career development administration, practices and services, fiscal and operations management/experience. Experience with MS Office. Knowledge of state, federal and local laws/regulations relating to programs, governmental compliance and other regulatory standards such as Title IV, WASC, and other accreditation standards. Passion for the development of future healthcare professionals. Passion for developing associates and colleagues and supporting their professional growth. Competency in financial management, leadership in an interdisciplinary environment, and systems thinking. Ability to thrive in leading a highly ethnic and culturally diverse student and associate community. Ability to use effective communication skills, both oral and written, including complex proposals and presentations, and effective listening skills. Ability to speak before public groups, committees and meetings. Ability to manage projects and people, participate in and facilitate group meetings. Ability to effectively use interpersonal skills, follow through with duties, provide attention to detail, and demonstrate the ability to motivate others. Ability to use creative facilitation and conflict resolution skills to resolve difficult and sensitive issues. Ability to understand and implement shared governance, teambuilding and collaborative decision-making process within and across division/department lines. Excellent analytical and organizational skills. Ability to self-direct, self-pace, multi-task and function well under pressure of deadlines and conflicting priorities. Ability to work with individuals at all levels of the organization. Ability to exercise good judgment. Willingness to work a flexible schedule. Ability to travel/drive locally on a weekly, daily and/or on an as needed basis. Do you want a career that allows you to make a difference in other people's lives? Discover what it means to truly believe in the work that you do at American Career College. For more than 40 years American Career College has had the privilege of educating students seeking careers in healthcare-guiding them through their transformational journey from student to caregiver. Our associates are united behind that purpose and share a deep commitment to our values of teamwork, collegiality, transparency, and a student-centric approach to all we do. This focus creates an aligned, nimble, and consensus-driven culture that is solution-oriented and supports our associates' professional growth. American Career College is proud to be an equal opportunity employer. We embrace diversity and are dedicated to creating an inclusive environment for all associates. Campus: ACC Richardson Campus Function: Executive Leadership

Position Title: Assistant Controller and Director of Financial Reporting Position Summary: The Assistant Controller and Director of Financial Reporting will be responsible for preparing all of the College's various internal and external financial statements, appropriate analysis of changes and trends and footnote disclosures in accordance with generally accepted accounting principles. This includes acting as a key source of financial reporting expertise and knowledge pertaining to the College's consolidation methods. This position is also responsible for research and analysis as it pertains to reviewing, analyzing, concluding and documenting the accounting treatment for non-routine transactions. This position will also oversee the staff maintaining general ledger accounts and the opening and closing of general ledger periods on a monthly and annual basis. Essential Duties and Responsibilities : Manage the preparation and distribution of the monthly, quarterly, and annual consolidated internal and external financial statements (balance sheet, statement of operations, statement of cash flows, statement of changes in capitalization) as well as those of the College's subsidiaries, ensuring their accuracy and conformity with generally accepted accounting principles (GAAP). Manage preparation of the quarterly and annual consolidated financial statements and footnote disclosures ensuring inclusion of all relevant and necessary disclosures, non-routine transactions, subsequent events, etc. completely, accurately, and on-time. Ensure that adequate supporting documentation is obtained. Prepare financial statements and monthly budget allocations, and comparison of actual revenues and expenditures to budget projections, including explanations of budget variances.Acts in conjunction with the Controller, and/or as a liaison to Investment Operations and Institutional Advancement to record gifts and administer insurance contracts.Collaborate with other employees within Business and Financial Affairs and other departments to obtain necessary information to prepare the College's consolidated financial statement disclosures. Maintain a footnote support binder and tie in all numbers and other relevant information to supporting documentation. Ensure financial statements and footnotes are reviewed by Vice President for Business and Financial Affairs and Treasurer and obtain internal certifications of the review. Maintain details of related party transactions and non-GAAP amounts. Prepare the annual financial statements for the College's two (2) 403b plans completely, accurately and on-time ensuring DOL deadlines are met. Collaborate with other College employees as appropriate, to obtain necessary information to update benefit plan footnote disclosures. Analyze and ensure the accuracy and adequacy of all accounting estimates including but not limited to allowance for doubtful accounts, depreciation, and asset retirement obligation. Evaluate and document key determinants / assumptions used to derive these estimates. Coordinate the gathering of auditor-requested workpapers, supporting analyses, and supporting documentation pertaining to the consolidated financial statements and footnote disclosures.Manage the annual external audit process and various other audits to include 403(b), single audit, grantor and insurance audits.Ensure compliance with all SEC, FASB, and eventual IFRS rules and regulations.Prepare reports required by regulatory agencies. Implement cash draw down procedures for federal, state, and private grants in accordance with published regulations. This includes timely preparation and filing of federal SF 425 reports and preparation of property reports;Perform analyses of various balance sheet and other general ledger accounts to ensure that account balances are recorded at proper amounts. Notes where corrections are needed, and makes corrections on a timely basis;Record monthly activities of College's various investment managers;Analyze general ledger to determine funding requirements of various construction and other projects, for review by CFO and Sr Vice President for Business and Financial Affairs, Treasurer. Required Qualifications: Bachelor's degree in Accounting with eight plus years of related and progressive financial managerial experience is required.This position requires comprehensive knowledge of financial accounting and reporting for private colleges. The work calls for strong management abilities and outstanding interpersonal skills to work with a diverse group of people, organizations, etc. Excellent analytical skills, problem solving abilities, and strategic thinking are essential.Excellent oral communication skills are required when presenting information and responding to questions from students, parents, employees, and the general public in one-on-one or group situations. Incumbent must be able to write business correspondence and procedure manuals plus compose memos, letters, and emails. Also, must be able to read, analyze, and interpret documents such as financial statements/documents, governmental regulations, professional journals, and procedural manuals. Good proofreading skills are essential.Intermediate level computer skills are required using the Microsoft Office Suite (Word, Excel, PowerPoint) and/or WordPerfect. Ability to type memos, business correspondence and prepare such things such as mail merges, flyers, spreadsheets, forms, and use formulas for computations is essential.This position requires that the incumbent understand the College's administrative computing system in such a way that productivity and efficiency can be maximized Preferred Qualifications: Education beyond an undergraduate degree preferred Certifications, Licenses, Restrictions : CPA is preferred. Physical Demands: While performing the duties of this job, the employee is regularly required to: walk, talk, and hear. The employee is frequently required to: use of hands for computers and to movie items, and reach with hands and arms. Employee is occasionally required to: stand, stoop or kneel or crouch or crawl, and lift and/or move up to 10 pounds. No special vision requirements beyond regular sight with the ability to adjust focus are necessary for performance of this position. Shift: Days % Travel Required: 1% - 25% Full Time/Part Time: Full-time Work Location/Schedule This position is eligible for a hybrid work arrangement. FLSA: Exempt Number of Vacancies: 1 Posting Number: SC0775P Posting Open Date: 04/16/2025 Open Until Filled: No EEO Statement: Spelman College is an EEO/Minority/Female/Disabled/Veteran/Title IX Employer and we participate in E-Verify. We are a smoke-free campus.

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: This role is an integral member of the Daiichi Sankyo (DS) Global Regulatory Intelligence & Policy, Center of Excellence (GRIP CoE), and is responsible for leading US regulatory intelligence acquisition, analysis, communication, and knowledge management, as well as leading US regulatory advocacy and policy activities for assigned issue sets. The role will work closely with the Vice President, Head of North America Regulatory Affairs, other regional Regulatory Intelligence & Policy (RIP) Leads, and cross functional stakeholders, and will conduct analyses and targeted advocacy via a global lens that ensures US intelligence and policy activities are globally coordinated and globally aligned to achieve maximum impact for patients and Daiichi Sankyo business. Additionally, this role will be responsible for the management and continuous improvement of the GRIP CoE Hub designed to provide global access to critical RIP information and resources. Intelligence: The US RIP lead will: 1) Lead the acquisition, analysis, communication, and knowledge management of US regulatory intelligence (RI); 2) Interpret, analyze, and apply US regulatory intelligence to inform strategic decisions of asset teams and leadership, as well as to inform the development of DS policy positions; 3) Lead the strategic development and implementation of an assigned project portfolio (including the development of technology enabled systems, tools, processes, and key performance indicators) for identifying, analysing, and leveraging changes, trends, and other developments in the regulatory landscape, through a global lens, across all key markets where DS operates. The US RIP lead will leverage a wide variety of diverse internal and external sources, databases and networks, to interpret regulatory information into actionable insights that relate to DS's portfolio of development and marketed assets, and synthesize and communicate these findings to relevant cross-functional stakeholders, to help inform future DS regulatory/development strategies, activities and ways of working. Policy/Advocacy: The US RPI Lead will lead DS regulatory policy and advocacy activities for an assigned portfolio of policy topics. For assigned US issue sets, this role will be responsible for maintaining and efficiently and effectively communicating the current pulse of the issue, developing the DS US position, contributing to the development of Global Regulatory Affairs positions (and potentially serving as both the US and Global GRIP Lead on assigned topics), leading public commenting and other advocacy on assigned topics to ensure that DS has a voice in defining and shaping new or proposed FDA regulatory opportunities/changes/requirements (policy, regulations, guidance, pilots, workshops, etc.), and for preparing DS teams to efficiently navigate these changes to seize opportunities and to mitigate risk. Policy/advocacy activities will include but are not limited to partnering with regulators, interacting and influencing trade associations and other key external stakeholders, securing and executing opportunities to present and publish externally, briefing senior leaders, regulatory affairs teams, and other relevant functions, as well as contributing to the development and execution of assigned global regulatory policy activities. US Focus but with Global Lens/Mindset: While the core responsibilities are US focused, the US Lead will routinely engage with other regional leads and global subject matter experts in regulatory and other DS partner functions to ensure intelligence is analyzed via a global lens and that DS policy development considers the global environment and implications to maximize the impact of intelligence analysis and policy shaping activities. The US Lead may also serve as the global policy lead for specific assigned issues and will contribute to the GRIP CoE's global deliverables. The US Lead will also have a key role in cross-region mentoring and development activities. Stakeholder Engagement: The role will engage internal/external stakeholders from across functions on key regulatory topics, particularly related to biologics/oncology, including coordinating GRIP CoE activities with RA-CMC, R&D & corporate affairs as needed. Responsibilities: Regulatory Intelligence (RI) - Lead the monitoring, collection, synthesis, analysis, communication, archiving, and retrieval of key regulatory intelligence in a systematic manner for the US region, (and for a limited number of global issue sets driven by US FDA regulatory policy). - Transform regulatory information into actionable insights specific to Daiichi Sankyo, that will facilitate the rapid and efficient development and approval of Daiichi Sankyo medicines. - Contribute US regulatory intelligence content and perspective into deliverables (e.g., Quarterly GRIP Insight Reports, Ad Hoc GRIP CoE Alerts Notes; Quarterly Global SOP Committee Updates; and other fora as assigned). - Deliver insightful, proactive (e.g., from routine monitoring of priority issues) and responsive RI and analysis (e.g., in response to internal asset team and GRA Leadership queries), both through a global lens. - Leverage RI analyses to inform strategic decisions at both asset and above asset levels (e.g., using external/internal precedence, case studies, statements from regulators, etc.). - Leverage regulatory intelligence to inform the development and successful execution of Daiichi Sankyo regulatory policy goals. - Develop and maintain strong collaborative networks/relationships with cross-functional subject matter experts (SMEs) and Daiichi Sankyo partner functions that generate, analyze, and consume intelligence. - Leverage and maintain expert proficiency in the use of internal and commercial third-party RI tools, and mentor others to use. - Lead the development, implementation, maintenance, and continuous improvement of assigned elements of GRIP infrastructure (e.g., systems, tools, and processes) that enhance the efficiency and impact of the GRIP deliverables and team. - Contribute to the efficient global operation and continuous improvement of the GRIP CoE (e.g., key performance indicators, team meetings, mentoring, representing the GRIP CoE on cross-functional GRA and intel projects, vendor interactions). - Regulatory Policy Prioritization: - Identify and establish a focused set of US Regulatory Policy priorities for external engagement that are aligned with DS functions and leadership, and will have maximum positive impact on patients and accelerating the delivery of the DS portfolio. Horizon scan for emerging US regulatory policy topics; adjust priorities as needed. - Lead DS regulatory policy and advocacy activities for assigned portfolio of policy topics. For assigned issue sets: - Monitoring Communication: Efficiently and effectively monitor communicate the current pulse of priority issues to Daiichi Sankyo stakeholders via a global lens that includes global context and implications (e.g., briefings to senior leaders, including in advance of trade association interactions). Prepare Daiichi Sankyo teams to efficiently navigate policy/regulatory changes to seize opportunities and to mitigate risk. - Position Development: Develop US regulatory policy/position papers, in partnership with Daiichi Sankyo subject matter experts, ensuring alignment with key stakeholders internally to ensure a unified voice for subsequent Daiichi Sankyo advocacy. Lead or contribute to development and finalization of DS Global Positions. Potentially serve as both US Global GRIP policy lead on assigned topics. - Advocacy: Develop and execute strategic advocacy plans to achieve policy-shaping objectives for key policy topics, and grow the positive reputation of DS. Position paper messaging to drive policy shaping initiatives across multiple channels. Leverage and partner with Daiichi Sankyo cross-functional leaders and subject matter experts (e.g., from across RD, Safety, Tech/Supply and Commercial) to engage externally and increase the impact of DS advocacy. Engage with key external stakeholders including regulators and trade associations to advance and secure the adoption of the Daiichi Sankyo perspective on priority issues. Lead public commenting and other advocacy to ensure that Daiichi Sankyo has a voice in defining and shaping new or proposed FDA regulatory opportunities / changes /requirements (policy, regulations, guidance, pilots, workshops, etc.). Secure and execute opportunities for GRIP as well as other Daiichi Sankyo GRA and cross-functional leaders and subject matter experts to present and publish externally with regulators and/or other influential organizations. Reports back key insights to the GRA Leadership Team and other relevant stakeholders to inform strategic decisions. Tracks impact of advocacy efforts and applies learnings to continuously refine policy messaging and tactics to increase the impact and likelihood of success . click apply for full job details

Description: Job Title: Associate Director / Director, Study Trial Master File (TMF) Location: Bala Cynwyd, PA Travel: Approximately 10% (domestic/international) Reports to: Chief Development Officer (initially) The Company: Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality. We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC. Our company's strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team's know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Position Summary We are seeking an experienced and detail-oriented Associate Director or Director to lead all aspects of Trial Master File (TMF) management for a single, global clinical trial. This TMF Owner will be fully accountable for the completeness, accuracy, quality, and regulatory compliance of the TMF for a global study, ensuring it remains inspection-ready throughout the study lifecycle. This is a hands-on leadership role that requires deep expertise in TMF operations, global regulatory standards, and cross-functional collaboration. The successful candidate will be a strong leader with excellent communication and collaboration skills, preferably with 10-15 years' experience in managing clinical TMFs across the US and EU, and significant vendor management experience. This role will require a minimum of 2 days a week of onsite presence (or more as business needs require) in our Bala Cynwyd, PA corporate office. Job Responsibilities TMF Oversight & Compliance Serve as the TMF lead for a global clinical trial, fully accountable for the accuracy, consistency, completeness, and regulatory compliance of the Trial Master File from study start-up through final archival Develop, update, and deliver TMF processes, procedures, and training in alignment with industry best practices and evolving regulatory requirements. Lead the TMF plan and build study eTMF and ensure completeness accordingly Ensure TMF documentation is consistent with specifications, internal SOPs, and applicable regulatory guidelines (ICH GCP, FDA, EMA, and other country-specific requirements). Maintain TMF inspection- and submission-readiness throughout the trial lifecycle, monitoring quality and implementing corrective actions when necessary. Act as the primary point of contact for all TMF-related activities, queries, and decisions for the trial. Stay current with regulatory changes and industry best practices, translating them into actionable process improvements. Process Management & Quality Control Conduct ongoing quality control reviews of TMF content to ensure accuracy, timeliness, and compliance. Establish and monitor TMF performance metrics, monitoring them, and proactively identifying and addressing documentation gaps. Report on metrics, highlighting risks, driving remediation, and presenting continuous improvement strategies to senior leadership. Drive continuous improvement in TMF operations, including CAPAs and lessons learned. Travel domestically and internationally ( 10%) for vendor oversight, study team meetings, audits, or inspections. Cross-Functional Collaboration Work closely with clinical operations, regulatory affairs, quality assurance, and other internal stakeholders to support timely and accurate documentation filing. Lead TMF-related communications with study teams, ensuring alignment on responsibilities, timelines, and expectations. Support inspection readiness activities, including internal reviews, mock inspections, and audit preparation. Manage and build strong partnerships with external vendors, CROs, and internal stakeholders to ensure consistent TMF standards, timely document flow, and adherence to project milestones. Manage third-party TMF vendor(s) involved in the trial, ensuring adherence to quality standards, timelines, and deliverables. Serve as the business owner of the eTMF system for the study, including oversight of configuration, access controls, and change management. Oversee records management for the trial, including off-site storage and archival, ensuring compliant chain-of-custody practices. Inspection Readiness & Regulatory Support Ensure the TMF is prepared for regulatory inspection at any point during the trial. Lead TMF reviews and remediation efforts in preparation for audits or inspections. Assist with audit response and CAPA development as needed. Other responsibilities Perform related duties as necessary or as assigned Requirements: Qualifications Minimum of 15+ years of relevant industry experience with a Bachelor's degree, or 10+ years with a postgraduate degree. Experience managing TMF for global clinical trials including direct vendor oversight Proven, hands-on experience with electronic TMF (eTMF) systems (e.g., Veeva Vault) and related clinical documentation platforms. Deep expertise in global regulatory requirements (e.g., ICH-GCP, FDA, EMA) and well-versed in industry best practices for Trial Master File (TMF) operations. Strong, practical knowledge of the DIA TMF Reference Model and its application within operational settings. Broad understanding of end-to-end clinical trial operations and processes, with direct involvement in inspection readiness and compliance activities. Exceptional communication skills-able to clearly convey complex information to diverse stakeholders and foster collaboration across cross-functional teams. Highly skilled in project management, with the ability to oversee multiple concurrent initiatives, establish priorities, and consistently meet critical deadlines. Recognized for strategic problem-solving, organizational acumen, and meticulous attention to detail in a fast-paced environment. Ability and willingness to work onsite at least two days per week, while maintaining strong collaboration in a hybrid work model. Benefits: Larimar Therapeutics offers all employees a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy. We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live. Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes. PI91f15ea60e7d-1581

POSITION SUMMARY The Assistant Director of International Student Programs plays a key role in supporting the Office of International Student Affairs (OISA) by fostering student success, belonging, and intercultural engagement. The Assistant Director develops creative, student-centered programming that addresses cultural adjustment, immigration compliance, and other unique needs of our global student body. The OISA supports approximately 350 degree-seeking international students and 60 alumni throughout their post-completion practical training authorization, and the College also hosts around 20 Exchange Visitors annually. This position leads several signature programs, including the Fischlowitz Travel Fellowship, Friends of International Students (which links students with a community host), a Cultural Attaché outreach program, the Gallery of Flags, and MOSAIC Magazine. They maintain the OISA s website and facilitate a creative social media presence for the office. They advise the International Student Organization, which coordinates two large student-led events: Food Bazaar and Cultural Evening. They broadly encourage student leadership by building partnerships and collaborative initiatives that advance Grinnell s international diversity and inclusion goals. The Assistant Director serves as a Designated School Official (DSO). They offer F-1 student advising on enrollment, travel, status maintenance, and employment eligibility. They vet and issue initial immigration documents, offer travel endorsements, and process SEVIS updates. This role also includes service on various campus committees as assigned, and regular engagement with colleagues in the Division of Student Affairs and related campus partners to ensure holistic support for international students. Key Responsibilities Office of International Student Affairs Staff Member (40%) Provide professional, culturally sensitive advising for international students, ensuring privacy, appropriate referrals, and student success. Coordinate OISA communications, including a weekly e-newsletter, social media presence, and relevant campus outreach. Manage annual programming (logistics, scheduling, supplies, reservations) and collaborate with Student Affairs and other relevant campus partners. Represent the OISA on campus committees and participate in professional development networks (e.g., NAFSA, ACM/GLCA). Student Programming and Belonging (40%) Lead signature programs including the Fischlowitz Travel Fellowship, Cultural Attaché Program, Friends of International Students, and MOSAIC magazine. Advise the International Student Organization (ISO) and help to support their major events like Food Bazaar and Cultural Evening. Develop creative programming and intercultural initiatives with campus and community partners. Coordinate activities for international students who remain on campus during break and vacation periods. Designated School Official & Regulatory Support (20%) Serve as a DSO for F-1 students, advising on enrollment, travel, employment eligibility, and maintaining visa status. Facilitate I-20 vetting and issuance, travel endorsements, and SEVIS compliance via the GrinnImmigration Portal (Terra Dotta ISS). Ensure compliance with record retention and assist with resources for non-resident tax obligations via Sprintax Returns. Stay current on federal regulations and institutional policies impacting F-1 visa holders. ABOUT GRINNELL COLLEGE Grinnell College is a top-ranking private liberal arts institution that values diversity, equity, inclusion, intellectual freedom, and social responsibility. We seek candidates that align with these values and have the ability and desire to advance our values and belonging within our community and the communities we engage in. Ideal candidates will be prepared to collaborate and contribute to the mission and values of the college across all constituencies.

The Portfolio Director is a key academic and strategic leader within the Global Academic and Learning Enterprise (GALE) at UMGC. Responsible for setting the vision, direction, and priorities for a portfolio of learning experiences within a specific disciplinary and industry domain, the Portfolio Director ensures alignment to workforce trends, employer needs, and academic innovation. This role curates a full spectrum of learning experiences-including degrees, certificates, micro-credentials, and workforce-based programs-and works in collaboration with cross-functional university teams to optimize learner outcomes, enhance access, and ensure career relevance. Positioned at the intersection of education and industry, the Portfolio Director is charged with ensuring high-quality, stackable, market-responsive learning experiences that support UMGC's commitment to serving diverse, global learners throughout their lifelong learning journey. Success in this role is defined by the ability to lead a high-performing, data-informed portfolio that delivers stackable, market-relevant learning experiences; cultivates meaningful collaboration across academic and operational units; and drives measurable improvements in learner access, engagement, and outcomes. Duties and Responsibilities: Establishes and leads the intellectual and strategic direction and priorities for the Finance and Economics portfolio of learning experiences, maintaining strong awareness of and alignment to required and emergent employer/industry knowledge, skills, abilities, and dispositions. Identifies and ensures stackability of the skills-based learning experiences in the portfolio, deliberately mapping pathways including non-credit, micro-credential, professional, and workforce development experiences through academic courses, certificates, and degrees. Develops relationships with industry and community partners, including employers, professional organizations, certification bodies, and other universities and community colleges to ensure curriculum alignment and emerging relevance. Remains connected to and conversant in national discussions about the post-secondary education landscape, learner outcomes, workforce needs, and educational innovations specifically in the disciplines and industries germane to their portfolio of learning experiences. Identifies new technologies, theories, and approaches within the Finance and Economics fields/disciplines to enhance learner preparation for the workforce and the quality of the learning experience. Innovates and collaborates with university stakeholders on ways to validate and credential diverse forms of prior learning and contributes to new credentialing models. Works with Product Management to evolve the portfolio based on labor market and learner demand, ensuring stackable, scalable, and timely offerings. Collaborates with departments and offices across the global university to deliver a best-in-class learner experience, including surrounding the learner in support from both academic and nonacademic vantage points, enhancing learner engagement, and resolving learner issues and grievances, leading to higher levels of learner success. Working collaboratively across the university, optimizes the quality and performance of learning experiences through collaborative, data-driven activities and initiatives to ensure a high-quality portfolio of learning experiences, including measures of learner satisfaction, engagement, learning, and the learner experience as drivers of learner success, persistence, retention, and completion. Monitors and assesses portfolio performance through data and analytics, identifying opportunities for improvement and innovation. Uses market and audience research for Product Management to assess portfolio performance in terms of the national post-secondary and employer markets and identify appropriate learning experiences to start, stop, and continue. With the support and collaboration of Student Affairs, identifies appropriate academic support services. With the support and collaboration of the Office of Community Engagement and Opportunity and other teams across the institution, monitors learner satisfaction, engagement, learning, success, persistence, retention, and completion by learner demographic groups with an explicit focus on eliminating achievement gaps and improving outcomes for learners from historically marginalized communities. Collaborates with key stakeholders (Integrative Learning Design (ILD) and the Center for Institutional Effectiveness (CIE in the use of assignment-, course-, faculty-, and program-level data to identify and initiate targeted and deliberate improvements to both the design and delivery of learning experiences. Partners with ILD to plan and convene Product Design Summits through which product vision, strategic direction, and alignment with employer/industry knowledge, skills, abilities, and dispositions are defined. Approves appropriate, industry leading SMEs to develop learning and curriculum content and collaborates with ILD in the revision of learning experiences, including course and program content, selection of learning resources, and design of learning assessments. Facilitates a global community of faculty, ensuring faculty are optimally prepared and supported to facilitate the learning experiences for which they are hired, to include maintaining fidelity to the curriculum while adding richness and value to the learning experience through the specific and deliberate inclusion of their applied, industry experiences Partners with the Faculty Affairs and Scheduling Team (FAST) to monitor teaching performance, provide coaching support, ensure alignment with instructional standards, and ensures that adjunct faculty provide a learning experience that meets learner needs, to include identifying and effectively addressing individual learner needs and issues, connecting learners with appropriate academic and social-emotional support services, and delivering personalized, timely, and substantive feedback and responses to learner assessments and questions. Convenes portfolio team meetings, maintains communications infrastructure (e.g., Program Hub, Course Announcements, SharePoint), and fosters a connected community of practice to ensure all faculty are abreast of changes in courses, program, and other learner experiences. Serves as national and international university spokesperson and point person for highly effective learner experience practices that result in learner acquisition of the skills and areas of study in their portfolio. May be required to teach, facilitate seminars, contribute to content and learning object development and curation, serve on committees, contribute to institutional initiatives, and perform other job-related duties as assigned. Competencies: Strategic academic leadership and cross-functional collaboration Deep knowledge of current and emerging workforce and education trends Understanding of the higher education landscape and its regulatory environment Data-informed decision-making and continuous improvement orientation Inclusive mindset and ability to build community across diverse and distributed teams and stakeholders Deep understanding of adult, online education best practices and emerging trends Excellent communication and stakeholder engagement skills Relentlessly curious about new ways to assess, certify, and credential learners and KSADs regardless of their origin Seeks out diverse perspectives and experiences of colleagues throughout the institution Willing and able to challenge the status quo Skills: Portfolio strategy and lifecycle management Learning pathway development Industry and labor market analysis Stakeholder relationship building (internal and external) Use of analytics platforms, dashboards, and qualitative data to monitor learner and faculty performance Key Collaborators: Vice President and Dean (Academic School): To align portfolio vision with school strategy, institutional goals, and performance expectations. Integrative Learning Design (ILD): To co-develop and revise high-quality, technology-enhanced learning experiences. Academic Administration: To ensure operational effectiveness, policy alignment, and strategic planning across academic units. Academic Pathways: To coordinate stackable learning experiences, optimize opportunities for credit for prior learning, and support seamless learner progression across credentials. Registrar: To align program and course structures with credit articulations and records processes. Portfolio Directors: To promote collaboration, share insights, and align interdisciplinary or cross-portfolio initiatives as a collegial community of practice. Global Collegiate Faculty: To ensure instructional alignment, course fidelity, and learner engagement across modalities and geographies. Partnerships/Corporate Learning Solutions: To co-create and customize pathways and programs in response to partner needs and evolving workforce trends. Product Management: To analyze labor market trends, assess program performance relative to market, and guide portfolio decisions. Faculty Affairs and Scheduling Team: To ensure faculty development, teaching quality, and instructional effectiveness across the portfolio . click apply for full job details