Role Description Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure Otsuka’s products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing. - Anticipate and develop strategies and/or contingency plans for CMC related scenarios in the areas of biologic/small molecule drug substances, drug products, and drug-device combination products. - Determine regulatory and scientific/technical requirements for CMC and GMP related submissions and inquiries. - Represent CMC RA in project team meetings and provide regulatory guidance and perspective to the cross-functional team in conjunction with global regulatory lead(s). - Prepare, coordinate and/or review all CMC and GMP related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements. - Develop and execute regulatory strategies for post approval changes for marketed products and communicate with respective cross-functional teams. - Prepare departmental job procedures. - Experience in CPP application filing through eCATS, 510(j)(3) reporting through nextGen portals is a plus. - Interact with manufacturing and quality groups, partner organizations, regarding CMC issues. - Independently manage preparation of INDs, BLAs, CTAs, amendments, supplements, and reports within company timelines and in accordance with regulations and guidelines. - Develop and maintain collaborative relationships with other local and/or global functional units [OPCJ CMC RA, Factory, Quality, MPDD, OPDC/OPEL Tech Ops] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc. - Participate in Health Authority CMC meeting preparations, rehearsals and/or meetings. - Assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges. - Independently handle monthly meetings with global cross-functional teams for assigned products. - Be proficient in the tools and systems needed for the function including and not limited to CREDO (doc management), ORIOM (regulatory information), Trackwise, TRS Viewer, Concur (expenses), and Microsoft office tools. - Perform other duties as assigned. Qualifications - Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP and related issues. - Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug/device combination products. - Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canada. - Comprehensive understanding of the global regulatory environment. - Proactive strategic thinker. - Operationally minded (know how to prepare a high quality technical document or submission using internal systems). - Strong analytical, problem solving, organizational and negotiation skills. - Strong collaborative inter-personal, communication, presentation and meeting leading skills. - Strong ability to work in a matrix environment and across cultural lines. - Computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook). - 7 years CMC regulatory experience in the pharmaceutical industry with a history of successful investigational filings and approvals of marketing applications as the CMC Regulatory lead. - Regulatory experience in handling controlled substance applications will be a plus. Requirements - Similar knowledge of EMA, Latin America and middle-east countries will be a plus. - 3 - 5 years of hands-on pharmaceutical product development, including scale-up and technology transfer to manufacturing and/or manufacturing experience is highly desirable. - As a CMC reviewer (assessor) with FDA or EMA is highly desirable. Educational Qualifications - Bachelors in Pharmaceutical Sciences or Chemistry or Pharm.D., Masters and Ph.D. preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology or Biology. - RAC certification a plus. Competencies - Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. - Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. - Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. - Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. - Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals. - Empowered Development - Play an active role in professional development as a business imperative. Benefits - Comprehensive medical, dental, vision, prescription drug coverage. - Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance. - Tuition reimbursement, student loan assistance. - A generous 401(k) match. - Flexible time off, paid holidays, and paid leave programs. - Other company provided benefits.

Role Description The Compliance Analyst supports the Compliance Team to establish and maintain industry best practices and provide regulatory compliance support to our business units. Responsible for receiving, reviewing, logging, and dispatching consumer complaints received from the Departments of Insurance and other regulatory agencies. Work closely with business units to ensure timely and compliant responses to the consumers and regulatory agencies and accurate record keeping. Supports the organizational goal of delivering legendary service by providing timely and actionable reporting related to the nature and drivers of regulated consumer complaints. - Maintains responsibility for receiving, reviewing, logging and dispatching consumer complaints received from the Departments of Insurance and other regulatory agencies. - Responsible for timely uploading of complaint responses to the applicable regulatory agencies. - Serves as a centralized point of contact for the business units and enterprise leadership for regulated complaint related inquiries. - Assists business with drafting and compliant completion of complaint responses. - Maintains key reports and other metrics of complaint management. - Helps to determine the need for new and revised business policies & procedures for complaint management. - Aids the business in building/documenting policy and procedures; assists in implementation. - Proactively drives and supports the delivery of appropriate training and communication related to complaint management. Qualifications - Bachelors Equivalent combination of education and experience. - 4-6 years Compliance, business, insurance, risk management and/or audit. Required. - Verbal and written communication skills at all levels across the organization. - Interacts effectively at different levels and with different audiences, both internal and external to the company. - Solid research and analytical skills. - Ability to analyze and interpret federal and state regulatory documentation. - Knowledge of insurance products, laws and services preferred. - Solid organizational skills. - Teamwork/alliance Building: Builds and maintains successful relationships within the company and with external contacts. - Self-Management: Takes responsibility for decisions and actions. Manages own work. - Proficiency with Microsoft Office software, including Outlook, Word, PowerPoint, Excel and Access required. - Ability and desire to learn other technology. Requirements - Occasional travel to off-site business meetings or conferences. Benefits - Health coverage for medical, dental, vision. - 401(K) saving plans with company match AND Pension. - Tuition assistance. - Floating holidays and PTO for community volunteer programs. - Paid parental leave. - Wellness programs. - Employee discounts (membership, insurance, travel, entertainment, services and more!).

Role Description The Team Lead, Grievance and Appeals oversees the day-to-day performance of grievance and appeals specialists, while ensuring all regulatory, compliance and HIPAA guidelines are met for Medicaid, Medicare and the Massachusetts Market. - Supervise staff for quality review, performance feedback, disciplinary issues and merit/bonus appraisal review - Meet all monthly, annual and semi-annual reporting deadlines - Work with Regulatory Compliance Officers to ensure that requests are resolved within timelines and tracked for reporting - Monitor Medicaid and Medicare processes to ensure that all regulatory requirements are followed - Work with support departments and compliance officers to ensure policies and procedures are current - Establish an audit process - Evaluate operations and identify process improvement needs - Identify irregular trends with grievances and appeals; work with other areas as appropriate to identify root causes and appropriate steps for resolution - Responsible for staffing, ensuring that open positions are filled, and evaluate future staffing needs - Review validation reports to ensure that grievances and appeals are accurate - Develop and monitor workflows for Grievance and Appeals Department that ensures maximum level of productivity - Monitor member-facing departments to ensure that grievances and appeals are resolved and reported to the Grievance and Appeals Department - Conduct audits and provide feedback to all areas that submit grievances and appeals - Facilitate timely resolution of member and provider issues - Ensure that Grievance and Appeals Specialists are available to respond to incoming calls - Coordinate incoming information and disseminate to staff to ensure accuracy of communication to internal and external customers - Create, review, revise and enforce company and departmental policies and procedures - Act as the contact point for CareSource on operational issues to all regulatory bodies in existing and future lines of business - Actively interact with IT department for immediate problem resolution and for coordination of data transmissions - Proactively keep the management team apprised of the team’s performance, projects and issues - Provide support to the Service Center during high call volume or other support as needed - Develop, deliver or coordinate the delivery of grievance and appeals training to other areas as needed - Perform any other job related instructions, as requested Qualifications - Associates Degree or equivalent years of relevant work experience required - Minimum of three (3) years of customer service experience in an HMO or related industry - Previous supervisory/leadership experience preferred Requirements - Basic computer skills including Microsoft Word, Excel and PowerPoint - Basic experience with ACD systems - Basic experience with Call Management Systems - Communication skills - Prior supervisory skills - Ability to work independently and within a team environment - Attention to detail - Familiarity of the healthcare field and knowledge of Medicaid - Critical listening and thinking skills - Training/teaching skills - Strategic management skills - Negotiation skills/experience - Proper grammar usage - Technical writing skills - Time management skills - Proper phone etiquette - Customer service oriented - Decision making/problem solving skills - Strong language skills - Ability to write comprehensive statements using proper grammar and sentence structure Benefits - Compensation Range: $62,700.00 - $100,400.00 - In addition to base compensation, you may qualify for a bonus tied to company and individual performance - Substantial and comprehensive total rewards package Working Conditions - General office environment; may be required to sit or stand for extended periods of time Licensure and Certification - None Company Description This job description is not all inclusive. CareSource reserves the right to amend this job description at any time. CareSource is an Equal Opportunity Employer. We are dedicated to fostering an environment of belonging that welcomes and supports individuals of all backgrounds.

Role Description As a member of the GRC staff at Runway, you will contribute to our governance, risk management, and compliance programs during a pivotal time in both our company's growth and the broader AI industry. This role combines traditional information security compliance with the unique challenges of ensuring safe and responsible AI system development. You will play a crucial role in ensuring our AI systems are developed and deployed responsibly, helping us maintain trust with customers, regulators, and the public while advancing the frontiers of artificial intelligence. What you’ll do - Design and implement a comprehensive GRC framework that addresses both traditional security controls and novel AI safety considerations. - Lead engagements with external auditors and assessors to obtain and maintain critical security certifications (SOC 2, ISO 27001/27701/42001, FedRAMP, etc.). - Own and help fulfill GDPR data subject requests, including access (DSARs) and erasure/deletion requests that involve coordinating with Legal, Support, and engineering on data sourcing and response workflows. - Review and redline the security and data protection terms of customer and vendor contracts (TOMs, DPAs, MSAs) in partnership with Legal. - Partner with AI research teams to develop and implement appropriate safeguards and controls for machine learning systems. - Create and maintain security policies, standards, and procedures that balance innovation with appropriate risk management. - Maintain AI governance documentation and internal AI usage guidelines, monitoring changes from model and AI tool providers (e.g., retention and data-use terms) and reconciling them into company policy. - Develop and oversee security awareness and training programs across the organization. - Drive continuous improvement of security controls and risk management processes. - Serve as a key advisor to leadership on security, privacy, and AI safety matters. - Manage relationships with customers, auditors, and other external stakeholders. Qualifications - 7+ years of experience in information security, risk management, or compliance roles. - Deep understanding of security frameworks and standards (NIST, ISO 27001, SOC 2). - Hands-on experience running SOC 2 Type II and ISO 27001 audits. - Experience building compliance programs in fast-paced technology environments. - Strong knowledge of privacy regulations and requirements (GDPR, CCPA) including operational experience handling data subject access and deletion requests. - Experience completing customer security questionnaires and supporting Sales on security due diligence. - Excellent communication skills with ability to effectively engage technical and non-technical stakeholders. - Experience with cloud security and modern development practices. - Understanding of machine learning concepts and AI development workflows. Preferred Qualifications - Experience in AI/ML company or research organization. - Experience with AI safety and ethics frameworks. - Background in implementing automated security controls. Benefits Runway strives to recruit and retain exceptional talent from diverse backgrounds while ensuring pay equity for our team. Our salary ranges are based on competitive market rates for our size, stage and industry, and salary is just one part of the overall compensation package we provide. There are many factors that go into salary determinations, including relevant experience, skill level and qualifications assessed during the interview process, and maintaining internal equity with peers on the team. The range shared below is a general expectation for the function as posted, but we are also open to considering candidates who may be more or less experienced than outlined in the job description. In this case, we will communicate any updates in the expected salary range. Lastly, the provided range is the expected salary for candidates in the U.S. Outside of those regions, there may be a change in the range, which again, will be communicated to candidates. Working at Runway Great things come from great teams. We’d love to hear from you. We’re committed to creating a space where our employees can bring their full selves to work and have equal opportunity to succeed. So regardless of race, gender identity or expression, sexual orientation, religion, origin, ability, age, veteran status, if joining this mission speaks to you, we encourage you to apply. Company Description - Universal World Simulator - GWM-1 - Gen-4.5 - General World Models - Robotics SDK - Conversational Real-time Agents - Runway Studios We're excited to be recognized as a best place to work: - Crain's - InHerSight - BuiltIn NYC - INC