• Serve as the Director of Wellness, EAP and Wellbeing Solutions for APM (US) • Own the strategy, design, performance and growth of a differentiated wellbeing and Employee Assistance Program (EAP) portfolio • Set the vision and roadmap for integrated wellbeing experiences and partner ecosystems • Partner with cross-functional stakeholders across clinical, operations, product/digital, analytics, and go-to-market teams to deliver measurable outcomes for members and clients • Define and evolve the US wellbeing and EAP strategy, including portfolio vision, positioning, multi-year roadmap, and investment priorities aligned to client needs and market trends • Translate customer, member and partner insights into an integrated solution across digital applications, clinical programs, and partner offerings • Lead market and competitive intelligence efforts to inform differentiation, partner strategy, pricing/value story, and prioritization of new capabilities • Establish outcomes framework and KPI definitions to guide decisions and measure performance • Lead cross-functional planning and execution across clinical, operations, digital/product, and service teams to deliver roadmap initiatives on time and at expected quality • Develop and execute the go-to-market/business development strategy for Assure Programs USA in partnership with global and local leadership and channel partners • Own the wellbeing/EAP value proposition and solution narrative; partner with Sales and Marketing on messaging, enablement, and competitive positioning

Title: Director of CMC Location: US-Lawndale Hybrid Job Description: Overview The Director of CMC is responsible for day-to-day leadership and execution of Critical Innovations’ Chemistry, Manufacturing, and Controls (CMC) activities, with primary oversight over analytical development, CMC strategy, and CMC program management. This position plays a key role in ensuring that the Company’s drug-led products meet internal scientific standards and applicable regulatory requirements. The Director of CMC leads the development, optimization, qualification, and transfer of analytical methods; oversees CMC documentation and regulatory-support activities; and provides cross-functional coordination to ensure alignment between other departmental partners. This position does not oversee formulation or process development but collaborates closely with those teams to ensure analytical readiness, CMC coherence, and timely development support. The ideal candidate possesses strong analytical chemistry/scientific expertise, excellent technical writing capabilities, a proven track record in CMC or analytical development for pharmaceuticals and/or combination products, and a deep familiarity with CMC regulatory expectations (e.g., 21 CFR Parts 210/211, 21 CFR Part 4, ICH Q8–Q11). The Director of CMC must be able to work independently, manage multiple projects, and operate effectively in a lean organization with extensive interaction with external contract research organizations (CROs) and cross-functional internal teams. This position is designated as a full-time on-site role and is expected to be performed primarily at the Company’s assigned work location. Any work-from-home, hybrid, telecommuting, or other flexible work arrangement is available only if approved under applicable Company policies and business needs, and may be modified, suspended, or discontinued by the Company at any time, consistent with applicable law. Reports to: VP of Research Duties and Responsibilities: The responsibilities of the Director of CMC typically include: Analytical Development Oversight - Oversee development, optimization, qualification, and transfer of analytical methods for drug substance and drug product testing. - Develop and manage analytical method lifecycle activities, including aging studies, purity and potency assays, impurity profiling, and device-related analytical evaluations (e.g., extractables/ leachables, dose delivery assessments). - Oversee outsourced analytical work, including method development, sample coordination, submission, review, and interpretation of test reports. - Ensure analytical documentation meets internal and regulatory standards, including method development reports, validation protocols, and method transfer packages. CMC Strategy - Support the Vice President of Research in establishing the Company’s end-to-end CMC development and regulatory strategy. - Define analytical acceptance criteria and control strategies aligned with Critical Quality Attributes (CQAs), product requirements, and clinical needs. - Contribute to risk assessments related to analytical methods, stability, and drug–device compatibility. - Ensure that analytical development aligns with combination-product requirements, including interactions between drug and device materials. CMC Program Management - Manage CMC timelines, milestones, deliverables, and cross-functional coordination. - Track and communicate progress on analytical development, stability studies, and CMC regulatory activities. - Coordinate CMC activities with other departments. - Support planning and execution of CMC-related activities at CROs and Contract Development and Manufacturing Organizations (CDMOs). Regulatory Support - Draft, review, and contribute to CMC sections of regulatory submissions (e.g., IND Module 3), method descriptions, stability summaries, analytical justification narratives, and combination-product integration sections. - Contribute to development of CMC regulatory strategy. - Provide analytical and CMC subject-matter expertise during regulatory interactions. - Oversee the maintenance of accurate documentation for analytical methods, test results, and CMC records in compliance with quality system requirements. Cross-Functional Collaboration - Collaborate with engineering and quality/regulatory to ensure analytical and CMC readiness for combination-product development. - Support process and formulation development teams by providing analytical insight, specifications, and method support needed for process work. - Participate in Management Review activities as requested. Compliance and Documentation - Perform and document all work in accordance with ISO 13485:2016, FDA’s Quality Management System Regulation (21 CFR Part 820), cGMP (21 CFR Parts 210 and 211), combination-product requirements (21 CFR Part 4), GLP, and internal Quality procedures. - Oversee maintenance of analytical-related records within product history files and Design History File components relevant to the drug constituent part. Skills and Experience: - Excellent written and oral communication skills. - Strong analytical and problem-solving abilities related to pharmaceutical analysis. - Track record of experience in direct management of key activities related to CMC development and strategy. - Experience with CMC activities for combination products preferred. - Extensive experience in analytical method development, optimization, and troubleshooting to support small- and large-molecule characterization. - Proven track record in analytical method development, optimization, and troubleshooting. - Experience leading a team of other scientists. - Demonstrated leadership for outsourced analytical work at CROs/CDMOs. - Proficiency in generating and reviewing CMC documentation for regulatory submissions. - Ability to work cross-functionally with scientific, engineering, and regulatory personnel. - Strong organization and time-management skills, with the ability to manage multiple concurrent tasks. - Proficiency with Microsoft Office Suite. Education and Training: - PhD or MS in analytical chemistry, pharmaceutical sciences, chemical engineering, or a related scientific discipline. - 7+ years of experience in CMC or analytical development for pharmaceuticals and/or combination products preferred. - Experience supporting IND or equivalent regulatory submissions preferred. - Experience working within ISO 13485 and FDA-regulated environments preferred. Critical Innovations is an Affirmative Action/Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veterans' status, or any other characteristic protected by law. To conform to U.S. Government Department of Defense regulations, you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State. Benefits: - 401(k) Safe Harbor Plan - Healthcare Insurance: Medical, Dental and Vision - Other Insurance: Life Insurance and Long-Term Disability (LTD) Insurance - Time Off: Paid Time Off (PTO), Paid Sick Leave, Paid Holidays, and Paid Bereavement Leave - Tuition Reimbursement Program - Performance Bonus - Incentive Unit Plan - Flexible Schedule - Lunches, Snacks, Events Schedule: Monday to Friday Salary: $140,000 -180,000 per year Privacy Policy | Critical Innovations

Lead and inspire a team of fundraisers to secure significant philanthropic support, develop donor strategies, and implement innovative approaches for relationship management, all while achieving ambitious revenue targets and cultivating major donor...

ATSU - Director Admissions and Enrollment Engagement (hybrid) Hybrid Remote • Kirksville, MO Description A.T. Still University (ATSU) is seeking a full-time, exempt Director- Admissions and Enrollment Engagement on the Kirksville, Missouri campus. The Director – Admissions Enrollment Engagement is a member of the admission leadership team responsible for the development and implementation of admission policies, processes, and recruitment planning. Specifically this leadership role is responsible for recommending, developing, and implementation of comprehensive recruitment communications to attract and engage prospective and current students and manage the Customer Relationship Management system by working closely with the Admissions team, Enrollment Services team, Information Technology Services, Communications and Marketing team and academic partners to optimize recruitment and retention efforts and enhance ATSU’s print and digital presence. This position reports to Assistant Vice Chancellor - Admissions and is Telecommute. Duties & Responsibilities - Responsible for Interview Day packets and presentations, recruitment slide decks, program information sheets, recruitment videos, admissions internal and external webpages ensuring compliance for required consume, disclosures, Admission Agreements, AMP Checklist, and other recruitment/retention tools/materials to ensure compliance proper style, professionalism, adhere to ATSU Style Guide and information accuracy. - Responsible for updates to the Admission sections of the ATSU University Catalog and ATSU Student Handbook. - Develop and maintain content calendars and editorial plans. - Responsible for annual review and configuration of the CRM platform including review and update of all journeys/campaigns and annual review and updates of Admissions/Enrollment Services Communication Plan in collaboration with the Admissions/Enrollment Services Leadership Team. - In partnership with Assistant Vice Chancellor-Admissions, Senior Director-Online Admissions, Assistant Vice Chancellor-Enrollment Services, and ITS, set CRM goals for maximum system utilization each application cycle. - Develop and implement workflows within the CRM to automate communications with prospective students identifying data and fields required for most efficient and maximum system operation. - In partnership with ITS, provide CRM training and support to admission team members. - Work closely with ATSU compliance stakeholders. - Assist ATSU in meeting student consumer disclosure requirements. - Develop and maintain Admissions’ Operating Procedures and training manuals working closely with both Admissions and Enrollment Services leadership team members to understand regulatory requirements and best practices. - Serve as a liaison with academic program partners, ITS, and system vendors. - Serve as member of ATSU team to test numerous software upgrades/updates and monitor system integrations. - Collaborate with ATSU’s Communication and Marketing department (C&M) to understand ATSU Branding and Style Guide applying ATSU standards to all communications. This ensures consistent messaging and visual identity across all communications. - Collaborate with content providers and C&M to create and develop new communications monitoring ATSU’s utilization of all 10 stages of the Admissions Lifecyle including lead nurturing, application nurturing, and pre matriculant nurturing. - Responsible for application setup, processing, and data analytics for all ATSU residential programs. - Coordinate all application, form, and process changes. - Analyze communication performance for impact on recruiting outcomes, make recommendations to adjust strategies, track and report CRM metrics, and provide reports as requested. - Attend orientations and special events establishing Admissions departmental visibility and Student Affairs representation. - Attend national conferences staying up to date on recruitment and higher education admission industry trends, including use of Artificial Intelligence (AI), and higher education compliance providing recommendations for system improvements and compliance updates as required. Requirements Education & Experience - Master's degree required. - Three to six years experience required. Background in higher education with experience preferred. - Knowledge of ATSU, academic programs, and higher education administration. - Supervision and team development preferred. - Experience with project management. - Prior experience in an academic department, admissions, financial aid, or registrar's office is helpful. - Experience implementing and maintaining policies and procedures in accordance with industry best practices, regulatory and higher education compliance. - Experience implementing and maintaining policies and procedures in accordance with industry best practices, regulatory and higher education compliance. Interested candidates should submit the following application materials: A cover letter detailing qualifications and interest in the position, resume, three references, and college transcripts. Incomplete applications will not be considered. ATSU offers a comprehensive benefits package including medical, dental, and vision coverages, among more. If eligible, employee-elected benefits would begin the first of the month following hire date. For more information, please visit: atsu.edu/employment/benefits. A.T. Still University (ATSU) does not discriminate on the basis of race, color, religion, ethnicity, national origin, sex (including pregnancy), sexual orientation, age, disability, or veteran status in admission or access to, or treatment or employment in its programs and activities.