• Support vendor management and oversight of end-to-end safety case processing and safety reporting activities performed by the safety vendor and CROs • Review safety vendor project plans to ensure processes and procedures are documented appropriately and maintained • Provide guidance and subject matter expertise to the safety vendor and CROs for safety operational activities • Monitor safety vendor deliverables and action items to ensure compliance with timelines • Ensure on-time submission of expedited and aggregate safety reports through effective vendor management and routine review of vendor performance metrics • Conduct routine retrospective quality control of safety cases processed by the safety vendor to ensure a high quality of safety cases and safety submissions is maintained • Ensure the safety vendor’s global safety database (Argus) supports Arcus’s needs through oversight of database updates (including MedDRA and WHO Drug updates), study configurations, expedited submissions via safety gateways, and site query management • Support oversight of safety data exchange with partners in accordance with Safety Data Exchange Agreements (SDEAs)/PV agreements • Provide safety operational support and expertise to clinical trial study teams as needed, including attending Study Team Meetings and writing/reviewing Safety Management Plans with oversight from Safety Operations leadership • Collaborate with Data Management to resolve discrepancies identified between the safety and clinical databases via SAE reconciliation • Partner with Safety Quality and Compliance to ensure inspection readiness • Collaborate with Arcus partners to support SDEAs/PVAs • Assist with the preparation of internal/external audits and global regulatory inspections • Escalate safety noncompliance issues and trends to Safety Quality and Compliance and support investigations of quality issues to ensure appropriate CAPAs.

Role Description AST is seeking a part-time highly experienced FOIA and Disclosure Subject Matter Expert (SME) to support our FDA CDER client in reducing complex FOIA backlog and supporting high-priority disclosure activities. This role supports the review, analysis, redaction, and release of scientifically and regulatorily complex records in accordance with the Freedom of Information Act (FOIA), Privacy Act, Trade Secrets Act, Federal Food, Drug, and Cosmetic Act, and applicable FDA disclosure policies and procedures. The SME will provide advanced-level support for highly technical and sensitive disclosure matters involving regulatory submissions, drug approval documentation, scientific review materials, and related records requiring specialized expertise in FDA regulatory processes and disclosure determinations. - Conduct advanced FOIA disclosure reviews involving scientifically complex and high-sensitivity FDA records. - Review and process regulatory submissions and supporting documentation, including: - NDAs (New Drug Applications) - BLAs (Biologics License Applications) - ANDAs (Abbreviated New Drug Applications) - NME and non-NME approval packages - Pediatric review materials (BPCA/PREA) - Analyze records for releasability and apply appropriate exemptions under: - FOIA (5 U.S.C. § 552) - Privacy Act - Trade Secrets Act - Federal Food, Drug, and Cosmetic Act - Perform detailed redaction and quality assurance reviews on scientifically rich and highly technical records. - Support FDA Open Government and proactive disclosure initiatives. - Utilize FDA enterprise systems and repositories to retrieve, analyze, and process records. - Assist with backlog reduction initiatives through high-volume, high-accuracy case processing. - Provide technical guidance and mentorship to FOIA analysts and review staff to promote consistency and compliance in disclosure determinations. - Coordinate with FDA stakeholders, disclosure staff, and legal/policy personnel as needed to resolve complex disclosure issues. Qualifications - Minimum 10+ years of FDA FOIA/disclosure experience supporting regulatory and scientific records review. - Demonstrated expertise applying FOIA exemptions and disclosure statutes to complex scientific and regulatory records. - Strong understanding of FDA drug development lifecycle, regulatory submissions, and approval processes. - Experience processing highly technical disclosure packages involving pharmaceutical and biologic products. - Demonstrated experience conducting high-volume disclosure reviews while maintaining exceptional quality standards. - Proficiency with FDA enterprise systems and regulatory repositories. - Ability to independently manage complex disclosure matters with minimal oversight. - Bachelor's degree in biology, Bioscience, Chemistry, Nursing, Public Health, Regulatory Affairs or similar. Benefits - The company offers a comprehensive benefits program, including medical, dental, vision, life insurance, 401(k) and a range of other voluntary benefits. - Paid Time Off (PTO) is offered to regular full-time and part-time employees. Company Description Work Where it Matters Akima Secure Technologies (AST), an Akima company, is not just another federal facilities contractor. As an Alaska Native Corporation (ANC), our mission and purpose extend beyond our exciting federal projects as we support our shareholder communities in Alaska. At AST, the work you do every day makes a difference in the lives of our 15,000 Iñupiat shareholders, a group of Alaska natives from one of the most remote and harshest environments in the United States. - AST provides support and employment opportunities and contributes to the survival of a culture that has thrived above the Arctic Circle for more than 10,000 years. - AST’s capabilities provide agile, innovative, and trusted information technology solutions to achieve, maintain and advance functionality, efficiency, security, and compliance. - As an AST employee, you will be surrounded by a challenging, yet supportive work environment that is committed to innovation and diversity, two of our most important values. - You will also have access to our comprehensive benefits and competitive pay in addition to growth opportunities and excellent retirement options.

Role Description We are seeking an experienced, strategic, and execution-focused Head of Digital Operations to lead the digital infrastructure, operational systems, and technology initiatives of a fast-growing U.S.-based e-commerce company. This is a senior leadership role responsible for overseeing: - Website development projects - Digital operations - AI implementation - Automation initiatives - Cross-functional execution You will work directly with executive leadership to optimize business systems, improve operational efficiency, and ensure digital projects are delivered on time and at the highest quality. The ideal candidate combines strong operational leadership with hands-on project management experience, thrives in fast-paced environments, and is passionate about leveraging AI and automation to scale business operations. Qualifications - Minimum 5+ years of experience in Digital Operations, Project Management, or Operations Leadership. - Proven experience managing website development projects from planning through launch. - Hands-on experience with WooCommerce and/or Shopify. - Experience leading cross-functional teams and managing external contractors. - Strong project management experience using platforms such as Monday.com, ClickUp, Asana, or similar. - Experience implementing and managing business software and SaaS platforms. - Advanced English proficiency (C1 or higher) with excellent written and verbal communication skills. - Strong leadership, organizational, and problem-solving skills. - Availability to work during Pacific Standard Time (PST) business hours. Requirements - Experience with CRM and marketing automation platforms. - Experience implementing AI and workflow automation solutions. - Knowledge of conversion rate optimization (CRO), UX/UI, and customer journey optimization. - Experience with sales funnels and e-commerce growth strategies. - Background supporting health, wellness, consumer products, or e-commerce organizations. Benefits - Fully remote leadership opportunity. - Competitive monthly compensation in USD. - Direct collaboration with executive leadership. - High-impact role with significant ownership and autonomy. - Opportunity to shape the future of digital operations through AI and automation. - Long-term career growth within an innovative and fast-growing company.

• Lead and drive strategic planning processes across the company, ensuring alignment between business goals and execution. • Identify operational inefficiencies and work cross-functionally to develop and implement scalable processes. • Develop business cases, conduct market research, and lead analyses to support strategic investments and partnerships. • Act as a force multiplier for the VP of Strategy and Operations and the Chief Business Officer, translating high-level vision into tactical execution. • Own key metrics and dashboards to monitor performance and ensure data-driven decision making. • Spearhead special projects related to international expansion, sales strategy, organizational design, and process optimization. • Partner with other departments to ensure operational alignment and delivery.