Cook Group

Role Description The Senior Medical Science Liaison (MSL) serves as a field-based scientific and clinical expert, supporting the company’s cell therapy portfolio. The Senior MSL builds trusted relationships with healthcare professionals (HCPs), key opinion leaders (KOLs), investigators, academic experts, and institutions, providing fair and balanced scientific exchange and gathering insights to inform the company’s medical strategy. The Senior MSL also supports the development and execution of the company’s medical education program for its cell therapy portfolio. In this role, the Senior MSL plays a critical part in education, evidence generation support, and HCP relationship management that facilitate the successful adoption and appropriate use of complex biotherapeutics. - Develop, maintain, and strengthen scientific relationships with HCPs, KOLs, and healthcare centers. - Provide accurate, timely, and audience-appropriate scientific and medical information related to the company’s cell therapy products, pipeline, and relevant disease states. - Serve as Scientific SME in the assigned therapeutic areas as well as the company’s therapeutic product. - Capture, synthesize, and internally communicate field insights on clinical practice trends, unmet needs, competitive intelligence, and evolving scientific data to inform scientific and commercial strategy. - Actively contribute to the setup and operationalization of the Medical Affairs function from a pre-approval regulatory environment to a commercial product portfolio. - Contribute field insights to inform Medical Affairs strategy and plans, Scientific engagement approaches, and insight-generation processes, including SOPSs and tools. - Partner cross-functionally to provide medical and scientific input. - Support medical review, scientific materials, and internal education as needed. - Support clinical trial activities, investigator-initiated research (IIRs), and real-world evidence initiatives. - Contribute to medical congress planning, execution, and follow-up. - Develop and deliver approved scientific presentations (e.g., disease state education, product mechanism, clinical data) to HCPs, treatment centers, and internal stakeholders via in-person and virtual interactions. - Represent the company at international, national, and regional medical conferences, engaging in scientific exchange and supporting activities such as poster or abstract submissions or presentations. - Review and support Investigator Sponsored Trial (IST) proposals, Early Access Program requests, and associated scientific documentation per internal governance processes. - Provide scientific support to Authorized Treatment Centers and internal partners, ensuring alignment with medical and procedural guidance. - Exemplify Cook MyoSite Core Values. - Maintain regular and punctual attendance. - Must maintain company quality and safety standards. - This position requires an ongoing commitment to upgrading knowledge, job skills, and abilities in addition to competency related to all duties and responsibilities listed above. - Ability to work in collaborative and independent work situations and environments with minimal supervision. - Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability. - Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals. - Trainability. - Must have effective verbal, written, and interpersonal skills. - Able to prioritize and operate proactively. - Must demonstrate critical thinking and proven problem-solving skills. - Strong interpersonal skills resulting in exceptional rapport with people. Proven success in initiating, promoting, and maintaining strong interpersonal relations. - Must be able to multitask. Qualifications - Advanced scientific or medical degree (PhD, MD, DO, PharmD or equivalent) in life sciences, biomedical engineering, immunology, cell biology, or a related field. - 5 years of Medical Science Liaison or Medical Affairs experience in pharmaceutical, biotechnology, or life sciences industry. - Experience applying Medical Affairs principles, including compliance and scientific exchange, in a field-based role. - Experience working cross-functionally within a matrixed organization (e.g., collaboration with Clinical, Commercial, Regulatory). - Experience engaging with healthcare professionals (HCPs) and presenting scientific or clinical data. - Proficient knowledge of Microsoft Office software and other general office equipment. - Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing. Preferred Qualifications - Experience in early-stage, startup, or high-growth organizations. - Prior involvement in building or scaling Medical Affairs processes or teams. - Exposure to clinical development, medical strategy, or launch preparation. - Previous leadership, mentoring, or project ownership experience. - Experience with relevant indications (bladder health and cell therapy). - Experience working with Key Opinion Leaders (KOLs) and industry leaders. - Experience supporting specialty pharmacy-distributed products. - Strong understanding of the clinical and regulatory landscape of cell therapies. - Hands-on experience engaging KOLs, HCPs, payors, and academic institutions. Physical Requirements - Remote / Field Based: General office or home office setting. - Ability to conduct and hear ordinary conversation and telephone communication. - Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required. - Ability to work under specific time constraints. - Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time. - Visual and manual acuity for working with computers and equipment.

Overview This is a REMOTE position. The Regulatory Affairs Specialist 2 responsibilities are narrowly focused to a specific country and/or region in which the Specialist has proficient language skills (reading/writing/speaking). This position requires the ability to speak, read and write in business level region specific language for purposes of communicating with regulatory authorities and international local Cook offices or distributors. The Regulatory Affairs Specialist II assists in development of regulatory strategies, obtains and maintains approvals, and serves as a communication liaison between the Cook manufacturer and the Cook International Local Office / Cook Distributor. Responsibilities - Communicate and interface directly with regulatory authorities to ensure product approvals are achieved in a timely manner, if needed.- Communicate Country/region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assist with the regulatory strategies.- Obtain and maintain product approval, and serve as a communication liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor.- Plan and prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific countries/regions.- Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.- Perform translation activities.- Provide support to currently marketed products as necessary including input on change requests, etc.- Collaborate with Regulatory Scientific Affairs on all high risk devices and new technologies.- Collaborate with the Clinical Functional Unit on projects requiring the collection of clinical data.- Provide support to currently marketed products as necessary including input on change requests, etc.- Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements. Qualifications - Bachelor’s degree in a life science (preferably biology or chemistry), engineering, or other related field (such as law); or experience of such kind and amount as to provide a comparable background.- Proficient in reading, writing and speaking region specific language(s). Physical Requirements: - Works under general office environment conditions.- Utilizes close visual acuity for working with computers and equipment.- Frequently required to sit, stand, walk, and communicate.- Requires occasional early morning or late evening teleconferences.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The CCS Product Data Intern supports the Custom Cell Solutions (CCS) business unit by learning CCS product offerings and ensuring complete, accurate, and current product data within Cook MyoSite’s Laboratory Information Management System (LIMS). The intern collaborates with cross-functional stakeholders to understand and improve the flow of product information through LIMS, ERP, and related systems, ultimately helping to optimize sales, inventory, and ordering processes. - Practical understanding of autologous and allogeneic cell-based product lines and associated regulatory considerations - Hands-on experience navigating and maintaining data in a GMP-compliant LIMS environment - Exposure to enterprise resource planning (ERP) and inventory management systems used in biotech manufacturing and distribution - Insight into product lifecycle management within a regenerative medicine company, from development through commercial order fulfillment - Skill development in data analysis, root-cause investigation, process documentation, and continuous improvement methodologies - Enhanced professional communication through participation in cross-functional product and operations meetings - Rapidly learn CCS product portfolio, including SKU structure, product IDs, and lot numbering conventions - Perform data entry, validation, and periodic reconciliation of CCS product information within the LIMS; ensure consistency with ERP master data - Assist in creating/maintaining product specification sheets, BOMs, and change-control documentation under guidance of Product Operations team - Attend weekly CCS product, demand-planning, and inventory meetings; capture minutes and track action items - Partner with Supply Chain and Commercial teams to map current sales-order and inventory workflows; identify pain points and propose improvement opportunities - Support small process-improvement or documentation projects (e.g., SOP updates, dashboard creation) as assigned - Prepare summary presentations and status reports for CCS leadership; communicate progress, risks, and recommendations - Perform other duties or special projects in support of the CCS business unit as needed - Maintain regular and punctual attendance - Must maintain company quality and safety standards - Ability to work in collaborative and independent work situations and environments with minimal supervision - Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability - Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals - Trainability - Must have effective verbal, written and interpersonal skills - Must maintain a high level of confidentiality - Must maintain a high level of professionalism, business acumen, and excellent customer service skills Qualifications - Actively pursuing a Bachelor’s or Master’s degree in one of the following (or related) fields: - Life Sciences (Biology, Biochemistry, Biotechnology) - Biomedical / Chemical Engineering - Supply Chain Management / Industrial Engineering - Business Analytics / Information Systems - Coursework or prior internship in cell biology, biotechnology manufacturing, supply chain, or data management - Familiarity with LIMS, ERP, or inventory management software (e.g., SAP, Oracle, LabVantage, LabWare) - Proficiency with Microsoft Excel (pivot tables, look-ups) and basic data-analysis or visualization tools (e.g., Power BI, Tableau) - Experience working in a regulated environment (GxP, ISO, or similar) is a plus - Proficient knowledge of Microsoft Office software, and other general office equipment Requirements - Ability to conduct and hear ordinary conversation and telephone communication - Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required - Ability to work under specific time constraints - Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time - Visual and manual acuity for working with computers and equipment - Must be able to lift/push/pull up to 50 pounds on a regular basis - Must be capable of performing PPE gowning procedures to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on occasion - Potential limited exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II Company Description At Cook MyoSite, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace. This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.

Overview Director, Business, Latin America Responsibilities Develop, communicate and lead the vision, business strategy, and plans for in-direct markets in Latin America, in alignment with overall company priorities. Lead, manage, mentor, and develop high-performing teams across diverse geographies. Build partnerships and work in collaboration with other U.S. based leaders within the Division, Functions and Operational Units to implement the Channel business strategy and ensure alignment in market priorities, programs and processes. Maintain a general knowledge of core divisions products/ procedures and applicable competitor products. Work closely with finance and other internal stakeholders to manage the P&L for the global channel business. Collaborate closely with business managers to implement the strategy for sales, marketing, clinical and business resources with distributors. Develop key market relationships and facilitate appropriate corporate involvement to identify key business opportunities and best practices to support the channel. Lead change initiatives and continuously evaluate through setting and monitoring KPIs and listening to feedback from customers, internal functions and operating units. Qualifications - Bachelor’s degree in Business, Marketing, or closely-related field. - Ten (10) years of progressive experience in Medical Device business leadership for Latin America. - Additional experience must include: - Managing teams based in Latin America - Responsibility for multiple medical device product lines in the Latin America Market - Entering new markets, managing distributor transitions, and launching new products in competitive environments - Driving sales growth and optimizing distributor relationships - Up to 75% domestic/international travel required. - May work remotely. - Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.) Employer: Cook Medical LLC, 1025 West Acuff Road, Bloomington, IN 47404 Apply online at https://www.cookmedical.com/careers/

Overview Sr. Regulatory Affairs Operation Specialist (Data Integrity) Responsibilities Support the governance and review of Regulatory Affairs data integrity while supporting digital transformation projects, including standardization of all regulatory affairs data, processes and procedures globally. Assist with on-boarding and integration of a new regulatory information management system support alignment of regulatory with the clinical and marketing functions utilizing the platform. Support the implementation, launch and maintenance of new systems and processes. Work across multiple functional projects to understand data usage and implications for data integrity. Identify various sources of data and oversee the extractions of source data to ensure integrity. Identify data mapping rules, ensure data quality and timelines. Assist in designing, planning, and managing the data migration process. Work with other subject matter experts and project teams to identify, define, collate, document, and communicate data requirements. Participate in data migration plans including migration risk, milestones, quality, and business sign-off details. Lead various teams to clean, transform, match, and populate migration templates to ensure data integrity. Plan, manage and QC the completion of the migration templates. Manage assigned risks and monitor potential impacts as part of the data migration plan. Develop and govern best practice, processes, and standards for the digital transformation process. Perform source system data analysis to manage source to target data mapping. Test static data and transaction data from one core system to another. Perform data migration audit, reconciliation, and exception reporting. Provide Statistical reports of data moved, transformed, cleansed, and loaded. Manage cross-program data assurance for physical data items in source and target systems. Qualifications 1. Bachelor's of Science degree in Regulatory Affairs or relevant scientific or life science field and two (2) years of experience in Regulatory Operations. Will accept a Master’s Degree in Regulatory Affairs or relevant scientific or life science field in lieu of the Bachelor’s degree and two (2) years of Regulatory Operations experience. 2. Additional experience must include: - managing and publishing regulatory submissions for investigational or marketed products to global regulatory authorities in Veeva Vault RIM. - configuration and vault loader functionality in Veeva Vault RIM. - industry standards, regulations, guidelines related to regulatory submissions for medical devices and their application to Veeva Vault RIM constraints or configurations. - evaluating modifications in the Veeva Vault data model and their effects on regulatory data integrity and accuracy. - developing and implementing data remediation strategies within Veeva Vault RIM to enhance regulatory operational efficiency. - multiple cloud-based RIMS systems (such as Veeva) in Regulatory and Regulatory Content Management and source Product Management systems (Oracle PLM, Windchill, SAP, etc.) 3. May work remotely. 4. Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position. Employer: Cook Incorporated, 750 Daniels Way, Bloomington, IN 47404 Apply online at https://www.cookmedical.com/careers/

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Operational Excellence intern will support OEO activities associated with strategic planning, business process management, and process improvement projects. - Learn aspects of the three business concepts supported by the OEO, including Business Process Management, Continuous Improvement, and Strategic Planning. - Organize process mapping sessions. - Map business processes in MS Visio using BPMN. - Assist in capturing, organizing, and managing established process metrics or key performance indicators. - Support the creation of strategic planning infrastructure and management. - Assist with ongoing maintenance of OEO SharePoint (intranet) sites. - Support data collection and data reporting for departments across the organization. - Support the implementation of continuous improvement activities and process redesign across the organization. - Support the execution of the Strategic Planning Communication Plan. - Work collaboratively with other team members and complete ad hoc requests as assigned. - Exemplify Cook MyoSite Core Values. - Maintain regular and punctual attendance. - Must maintain company quality and safety standards. - Ability to work in collaborative and independent work situations and environments with minimal supervision. - Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability. - Demonstrate trainability (ability to develop knowledge, skills, and abilities). - Must have effective verbal, written, and interpersonal skills. - Must possess excellent organizational skills and the ability to follow complex processes, procedures, and systems. - Demonstrate critical thinking and ability to execute goals set by the organization and mentor. - Must be dependable and detail-oriented. - Must maintain a high level of professionalism and business acumen. - Experience with HTML editing preferred. - Knowledge of continuous improvement/lean and six sigma preferred. Qualifications - Junior or Senior undergraduate students majoring in Business (Operations Management focus preferred), Engineering (Industrial or Bio preferred), Biology/Life Sciences (with interest in industry), or a related field. - Proficient knowledge of Microsoft Office software and other general office equipment. - Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing. Requirements - Ability to conduct and hear ordinary conversation and telephone communication. - Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required. - Ability to work under specific time constraints. - Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time. - Visual and manual acuity for working with computers and equipment. Benefits - Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy, and HIPAA regulations. - At Cook MyoSite, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. - Cook MyoSite is proud to be an equal opportunity workplace.

Role Description We have an exciting opportunity for an experienced health economics and value professional who wants to directly lead, shape and grow Cook Medical’s global value-based healthcare and health economic agenda, working closely with Global Health Economics leadership to drive change and adoption company-wide. As part of our expanding Health Economics team, this role will focus on market access by shaping projects and creating user-friendly health economic models and value tools, in partnership with commercial and functional teams. This role will collaborate with and advise peers and internal stakeholders on clinical/health economic studies, and identification and development of new business opportunities. The successful candidate will: - Demonstrate strong communication, collaboration, and project management skills. - Have an analytical mindset and data-based approach to create clear concise value tools, translating value claims into quantitative/health-economic models. - Enjoy being challenged by finding the value story behind the existing data and is comfortable challenging the status quo to drive new processes forward. - Thrive working autonomously, be confident in making decisions to ensure timely project progression and focus on producing key impactful deliverables to support health economic and value conversations. Possess these capabilities: - Produce insightful visualizations of large data sets. - Translate complex technical and clinical data in an easily digestible and interesting manner. - Lead change at all levels. - Responsible for managing market access programs, projects and creation of user-friendly health economic models and value tools, with a deployment to external customers while partnering with relevant teams, in alignment with Division and specialty goals, priorities and overall company strategy and vision. - Collaborate with, advise and influence peers and company stakeholders on clinical/health economic studies, and identify and contribute to the development of new business opportunities. Qualifications - Minimum 7 years relevant experience, including health economics, market access, and/or reimbursement. - Prior experience and deep knowledge in health economic modelling and creating value messaging and support tools. - Demonstrated ability to work effectively autonomously as well as in teams. - Broad project management skills with experience prioritizing and managing large/complex and simultaneous projects to completion. - Excellent communication skills (writing and verbal) with strong ability to communicate complex concepts in a simple and engaging manner. - Prior experience presenting to leadership and external audiences. - Demonstrated ability to create structure within ambiguity. - Demonstrated strong relationship building skills. - Proficient in Microsoft Office with advanced Excel skills in modelling and analysis. Requirements - Advanced graduate degree (Ph. D. or master’s degree) in health economics or related field. - Health economics, market access, and/or reimbursement experience in Medical Device or pharmaceutical industry. - Demonstrate positive and constructive behaviors that drive team cooperation in achieving objectives. - Experienced in providing coaching, guidance and training to other employees. - Demonstrate excellent leadership and presentations skills. - Excels in a highly collaborative team setting. - Demonstrate the ability to think strategically. Physical Requirements/Work Environment - Ability to travel as needed. - Work under general office environmental conditions. Other Requirements - Employee signs a non-competition and confidentiality agreements in relation to his/her employment with Cook. - Employee acts in compliance with company policies including but not limited to, the Cook Employee Manual, Cook Code of Conduct, Cook Electronic Information Policy, Product Complaints, HIPAA regulations and Cook Policy & Guidance On Interaction with Healthcare Professionals.