Cristcot

Role Description The Medical Science Liaison will develop and maintain professional relationships with external healthcare practitioners to provide comprehensive medical and scientific support for the therapeutic area of ulcerative colitis. Midwest Territory: Illinois, Wisconsin, Minnesota, Iowa, Nebraska, Tennessee Primary Relationships - Collaborate closely with Medical Affairs, Clinical Development, Market Access, and Commercial within Cristcot. - Develop and maintain relationships with healthcare practitioners and opinion leaders outside Cristcot. Primary Job Responsibilities - Engage in scientific exchanges around product information, disease education, and research ideas/activities with physicians and ancillary healthcare professionals. - Work cross-functionally with Research & Development and Commercial colleagues to coordinate responses to customers' scientific and medical needs. - Accountable for the accurate and timely documentation of all activities. - Identify Medical Experts, consultants, investigators, and healthcare professionals. - Ensure timely, effective, and appropriate communication of current and emerging medical and scientific information. - Present data on Cristcot products to HCPs including physicians, academic institutions, researchers, and allied health care professionals. - Engage with HCPs to bring back critical customer insights and feedback. - Conduct scientific exchanges related to Cristcot’s products at Centers of Excellence and Academic Medical Centers. - Demonstrate high scientific knowledge and competency of Cristcot therapeutic disease states, products, and competitor data. - Support research and development programs as requested by R&D, Clinical Operations, and Medical Affairs Departments. - Provide medical and scientific support to payers, commercial managed markets, and related health care organizations. - Deliver and implement effective product and disease-state training and mentoring to internal colleagues. - Identify, develop, and maintain credible relationships with key medical, pharmacy, and health outcomes influencers. - Provide timely, fair balanced, objective, scientific and evidence-based medical information to health care customers. - Full support and execution of Medical Affairs plans aligned with overall company goals and asset strategy. Qualifications - An advanced degree in the life sciences field (PharmD, PhD, MD, and NP/PA) or relevant field medical experience. - Gastroenterology and ulcerative colitis experience strongly preferred. - A minimum of 5 years of experience as MSL required, unless candidate has strong related experience. - Other Pharmaceutical experience – Medical Information, Medical Strategy, Clinical management/trial experience and 2 years clinical or research experience (non-pharma) is preferred. - Effective presentation skills and advanced proficiency in interpersonal skills (listening, probing, persuasiveness, negotiation). - Knowledge of the PhRMA code of conduct, the Sunshine Act, HIPAA regulations, Promotional Regulations, and all applicable laws and regulations. - Able to quickly understand and dialogue on subjects relevant to Cristcot’s areas of interest. - Up to 70% domestic travel; some of which will be overnight in nature. - Applicants must already reside in, or be able to work within, the territory.

• Coordinating commercial workflows, maintaining operational documentation, supporting communications and training logistics, and assisting with financial tracking activities • Supporting the day-to-day execution of commercial initiatives, operational projects, and cross-functional activities to ensure efficient business operations • Coordinating meetings, launch activities, workflows, timelines, and deliverables while providing administrative and operational support to the commercial team • Schedule, coordinate and support execution of commercial initiatives, meetings, launch activities, and ongoing operational projects • Assist with management of commercial workflows, calendars, timelines, and cross-functional deliverables • Support training logistics, distribution lists, and commercial communications • Maintain commercial documentation including contracts, vendor records, pricing files, presentations, and SOPs • Draft, format, maintain, and update commercial SOPs, work instructions, templates, and operational documentation to support scalable business processes • Ensure consistency, accuracy, and professional formatting across commercial presentations, reports, policies, and internal/external documents • Track purchase orders, invoices, expense reports, and budget-related activities in partnership with Finance • Strong technical writing and document formatting capabilities with attention to detail and consistency • Ability to create clear, professional, and compliant operational documentation • Develop and edit PowerPoint presentations for internal and external use

• Hire, develop, and lead a team of Territory Business Managers (TBMs), driving performance above target through structured coaching and development • Coach team members on consultative selling, account management, and territory planning to meet or exceed goals • Develop and execute a regional sales strategy aligned with national objectives, focusing on high-value opportunities and target accounts • Monitor and drive performance metrics including TRx, NRx, market share, and HCP engagement using CRM and analytics tools • Provide regional insights on payer dynamics, customer needs, and competitive landscape to inform broader commercial strategy • Foster a culture of accountability, setting clear expectations and managing performance effectively • Adapt regional strategies based on market changes including competition, access challenges, and payer dynamics • Lead cross-functional collaboration with Marketing, Medical Affairs, Market Access, and Commercial Operations • Support adoption of digital and AI-enabled tools to enhance field effectiveness and customer engagement • Build and maintain strong relationships with key customers, accounts, and healthcare stakeholders • Ensure compliance with all regulatory, legal, and company policies • Manage regional budgets and allocate resources effectively to maximize return on investment

• Support Cristcot in its growth by leading the manufacturing operations of drug-device combination products. • Manage contract manufacturers (CMOs) to ensure reliable, compliant, and cost-effective production of device components and finished combination products. • Oversee production schedules, equipment readiness, resource allocation, and line performance metrics. • Ensure compliance with GMP, FDA, ISO, and company quality standards in all device-related operations. • Work closely with Manufacturing, Quality, Regulatory Affairs, and Supply Chain teams to support product development, validations, launches and commercial product supply. • Support technology transfer of device and combination product processes from development to manufacturing. • Ensure timely delivery of devices for clinical trials and commercial products. • Lead relationships with external manufacturing partners, ensuring adherence to quality, delivery, and cost objectives. • Monitor supplier performance and conduct regular business and technical reviews. • Drive process improvements, Lean Manufacturing initiatives, and troubleshooting for device assembly and packaging. • Lead validation efforts (equipment, process, packaging, and cleaning), ensuring compliance with regulatory standards. • Ensure accurate and complete documentation including batch records, deviation reports, CAPAs, and change controls. • Support audits and inspections by regulatory authorities and partners.

Role Description The Senior Administrative Associate plays a critical role in supporting the day-to-day administrative operations of a growing biotech organization. This position provides cross-functional administrative support across HR, Finance, and IT while serving as a key operational partner to ensure internal processes run smoothly. This role also serves as a backup to the CEO’s Executive Assistant, providing occasional executive support and ensuring continuity of administrative operations when needed. The ideal candidate is highly organized, proactive, and thrives in a dynamic, fast-paced biotech environment. Primary Job Responsibilities - Provide comprehensive cross-functional administrative support across Human Resources, Finance, IT, and administrative operations. - Coordinate meetings and projects, manage documentation and records, assist with onboarding, expense tracking, invoice processing, interview logistics, and office operations. - Perform executive backup tasks such as scheduling, travel, and event planning. - Contribute to improving administrative processes and workflows by tracking timelines and following up on deliverables. Activities of the Senior Administrative Associate - Cross-Functional Administrative Support: - Provide administrative support across core business functions including Human Resources, Finance, and IT. - Coordinate internal meetings, cross-functional projects, and department logistics. - Maintain organized documentation, records, and internal resources. - Assist with preparation of presentations, reports, and internal communications. - HR Administration: - Support HR initiatives including onboarding logistics, employee engagement activities, and internal events. - Assist with scheduling interviews and coordinating candidate logistics as needed. - Maintain confidential employee records and assist with HR documentation. - Help coordinate company-wide meetings, training sessions, and HR programs. - Finance Administration: - Assist with expense tracking, invoice processing, and vendor coordination. - Support preparation and organization of financial documentation and reports. - Coordinate meetings related to budgeting, forecasting, and financial planning cycles. - IT & Office Operations Support: - Assist with employee onboarding logistics including equipment coordination and system access. - Help coordinate IT requests, vendor support, and internal technology needs. - Support office operations including supplies, vendor coordination, and workspace logistics. - Executive Office Backup Support: - Serve as backup to the CEO’s Executive Assistant during absences or high-demand periods. - Assist with scheduling meetings, coordinating travel arrangements, and preparing executive materials when needed. - Support planning and logistics for executive leadership meetings and company events. - Process & Operational Support: - Help improve administrative processes and workflows across departments. - Track project timelines, meeting follow-ups, and cross-functional deliverables. - Act as a reliable administrative partner across the organization. Qualifications - High school diploma; Bachelor’s degree preferred. - 2-5 years of administrative or operations experience, preferably in biotech, pharmaceutical, healthcare, or a high-growth environment. - Experience supporting multiple departments or executives simultaneously. - Strong organizational and time management skills with exceptional attention to detail. - Excellent communication and interpersonal skills. - Ability to handle sensitive and confidential information with discretion. - Proficiency in Microsoft Office (Excel, PowerPoint, Outlook) and collaboration tools (Teams, Zoom). - Highly organized and detail-oriented. - Strong multitasking and prioritization skills. - Proactive and resourceful problem solver. - Collaborative and service-oriented mindset. - Ability to operate in a fast-paced, evolving environment.

• Lead the development and execution of the commercial operations strategy aligned with corporate and commercial objectives. • Build and operationalize launch readiness plans to support the company’s first and future product launches. • Partner with Commercial leadership to support annual brand planning, strategic planning, and long-range commercial forecasting. • Ensure operational readiness across sales, marketing, market access, patient services, and analytics functions. • Establish scalable infrastructure, processes, governance, and KPIs to support commercial growth. • Design and optimize field force infrastructure including territory alignment, targeting, call planning, deployment strategy, and performance management. • Lead incentive compensation design and administration while ensuring compliance and alignment with business objectives. • Oversee CRM systems, commercial platforms, dashboards, and reporting tools to support field execution and customer engagement. • Develop sales enablement capabilities and operational processes to maximize field effectiveness and customer experience. • Build and lead commercial analytics capabilities including forecasting, market research, competitive intelligence, and performance reporting. • Establish executive dashboards and reporting processes to support data-driven decision making. • Oversee implementation and optimization of commercial systems and technologies, including CRM, data warehouses, analytics platforms, and digital engagement tools. • Ensure strong data governance, operational efficiency, and business continuity across commercial systems and processes. • Serve as a strategic partner to the Chief Commercial Officer and Commercial Leadership Team.

• Lead the strategic planning, implementation, and management of all information technology systems and infrastructure. • Interface with executives and SMEs across the organization. • Work with outside vendors and partners to scope and implement platforms, technologies, and services. • Develop and execute the company’s IT strategy aligned with business objectives and administrative priorities. • Build, lead, and mentor a high-performing internal IT team. • Develop strategy and identify use cases for standalone AI tools. • Oversee day-to-day IT operations, ensuring reliable delivery of services across all business functions. • Lead IT systems readiness for product launch. • Ensure all systems meet regulatory requirements and maintain audit/inspection readiness. • Oversee IT infrastructure and implement robust cybersecurity frameworks. • Manage relationships with IT vendors and oversee outsourced partners.

• Lead and manage the Quality department, including hiring, training, and performance management • Ensure compliance with cGMP, FDA, EMA, ISO 13485 and other global regulatory requirements • Oversee quality systems including CAPA, deviations, change control, and document management • Function as the primary quality interface with CDMOs and testing labs. • Drive inspection readiness and lead internal audits • Review and approve batch records, SOPs, change controls, methods, specifications, protocols and reports, and quality-related documentation • Collaborate with cross-functional teams to support product development and commercialization • Manage supplier quality and oversee vendor qualification processes • Identify and implement continuous improvement initiatives within the quality system • Monitor key quality metrics and report trends to senior leadership • Ensure proper investigation and resolution of quality issues and complaints

• Generate financial reports and dashboards to analyze key performance indicators (KPIs) and financial metrics to provide insights into business performance • Prepare comprehensive financial reports, highlighting key financial insights and trends • Assist in the preparation of presentations and reports for executive leadership and board meetings • Ensure the accuracy and integrity of financial data for reporting purposes • Assist in the implementation of FP&A software tools • Assist in the development, maintenance, and management of annual budgets, working closely with department leaders to establish financial goals and targets • Prepare scenario planning for 3 statement financial models • Contribute to the forecasting process by providing accurate and timely financial projections • Conduct detailed expense and headcount variance analysis to assess budget versus actual performance • Prepare presentations outlining and explaining reasonings for variances • Monitor and analyze expenses, identifying opportunities for cost control and efficiency - improvements • Support department leaders in managing budgets and achieving financial targets • Own and update financial models and ROI analysis to support decision-making • Assist in evaluating the financial impact of strategic initiatives and business strategies • Own special projects and ad hoc analysis as directed by senior management • Provide financial support for strategic initiatives and operational improvements

• Manage the lifecycle of controlled documents including SOPs, work instructions, policies, and templates. • Administer and optimize the electronic document management system (eDMS) on an ongoing basis, as needed. • Ensure proper version control, archival, retrieval, and distribution of documents • Establish and maintain document control procedures aligned with GxP requirements • Ensure all documentation complies with FDA, EMA, ISO 13485, and ICH guidelines (e.g., 21 CFR Part 11, 210, 211, 820) • Support internal and external audits, inspections, and regulatory submissions • Maintain audit-ready documentation and ensure inspection readiness at all times • Partner with QA to enforce document control policies and best practices • Develop and implement scalable document control processes to support company growth • Identify gaps and drive continuous improvement initiatives • Lead implementation or upgrades of document management systems • Work closely with Quality, Regulatory, Clinical, CMC, Medical Device, Commercial, and Manufacturing teams • Train employees on document control procedures and systems • Serve as the subject matter expert (SME) for document control across the organization • Hire, mentor, and manage document control staff as the organization grows • Establish performance metrics and ensure high-quality output