
Penumbra, Inc.
Remote Jobs
35 Jobs
• Provides leadership in the planning, design, and execution of clinical studies sponsored by Penumbra to assess safety and effectiveness of products. • Works with confidential subject and company data, and interfaces with a variety of internal and external stakeholders. • Develops/maintains project timeline inclusive of startup through completion. • Drives development, approval, and distribution of study-related documents and study tools for investigational sites and review committees. • Manages distribution, collection and tracking of regulatory documentation to help ensure audit readiness. • Negotiates study budgets with sites, Core Labs, and other vendors. • Attends site visits as necessary. • Contributes to process improvements that help foster continuous improvement. • Helps update and maintain study trackers and dashboards. • Participates in system user acceptance testing. • Manages vendors such as Core Lab. • Organizes and manages Investigator Meetings. • Works with data management to develop systems for and track project metrics. • Drives development, approval, and distribution of study-related documents including Case Report Forms and study manuals. • Monitors progress of studies, identifies study-related trends/issues and implements corrective actions when necessary. • Represents the Clinical Affairs Department on cross-functional meetings and projects as needed.
• Drive the EMEA marketing strategy for the Neurovascular therapy area in alignment with global priorities • Lead product launches and lifecycle management across EMEA markets with strong field execution focus • Partner closely with Sales on go-to-market execution, pricing discussions, and regional commercial initiatives • Support demand planning and forecasting inputs for the Neurovascular portfolio in collaboration with cross-functional teams • Develop and localize marketing materials and sales enablement tools for physicians and clinical stakeholders • Actively support EMEA congresses, customer workshops, physician trainings, and hospital visits • Build and maintain strong relationships with KOLs, clinical partners, and key stakeholders through continuous field engagement • Gather and translate insights from the field, customers, and competitors into actionable input for execution and planning • Monitor key business metrics such as sales performance, market dynamics, and customer feedback to support ongoing optimization
• Prepares analysis programs to support the preparation and statistical analysis of clinical data. • Coordinates the statistical programming activities for multiple clinical projects. • Ensures internal consistency of output. • Assesses consistency with other projects and activities. • Follows specifications, develops algorithms and writes programs to create datasets. • Produces data listings, summary tables and graphs using analysis software. • Independently checks data listings, summary tables and graphs. • Imports and exports data. • Assists data management group in performing data edit checks to facilitate data cleaning. • Maintains complete and in-depth understanding of all Clinical Data Interchange Standards Consortium (CDISC) guidance documents and implementation guides, as well as FDA guidance and regulations regarding electronic submission of data. • Prepares clinical trial datasets and programs for regulatory submission. • Following statistical analysis plan, writes specifications for analysis datasets. • Interacts with the project statistician and other programmers participating on a project team. • Manages the data warehouse used to manage libraries of clinical study data. • Interacts with regulatory affairs, quality assurance staff, and external clinical system vendors. • Mentors less experienced statistical programmers. • Acts as the subject matter expert on CDISC and good statistical programming practices. • Builds efficient SAS coding and macro libraries. • Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements. • Adheres to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Verantwortung für die nachhaltige Entwicklung und den Ausbau des Vertriebsgebiets • Aufbau langfristiger Partnerschaften mit Kliniken und interventionell tätigen Ärzten aus Radiologie, Gefäßchirurgie und Kardiologie • Beratung und klinische Unterstützung bei der Anwendung unserer innovativen Penumbra-Produkte • Eigenständige Umsetzung von Produktneueinführungen sowie Durchführung von Präsentationen bei Anwendern und Einkauf • Strategische Analyse und Weiterentwicklung bestehender Accounts sowie Identifikation neuer Marktpotenziale • Aufbau und Pflege enger Beziehungen zu relevanten Entscheidungsträgern und Meinungsbildnern • Umsetzung regionaler Verkaufs- und Marketingstrategien mit hoher Eigenverantwortung • Begleitung interventioneller Prozeduren und Unterstützung direkt im klinischen Umfeld • Repräsentation von Penumbra auf Kongressen, Workshops und Fachveranstaltungen • Enge Zusammenarbeit mit crossfunktionalen Teams auf nationaler und europäischer Ebene
• The Sr. Manufacturing Engineer, Operations Systems provides leadership in the engineering, design and development of new products or changes to existing products, processes, and equipment. • Interfaces with and furnishes scientific knowledge to multi-disciplinary teams overseeing development of neurovascular devices. • Provide engineering support on existing devices for manufacturing. • Create and execute an integrated cross-functional project plan. • Fluently navigate quality management systems within scope and have general knowledge of quality systems beyond scope. • Develop new processes for medical devices and components. • Execute tasks independently and does not require assistance nor guidance. • Think strategically within scope. • Effectively and succinctly communicate task or activity status, assumptions, risks, timeline, and escalations cross-functionally and interdepartmentally. • Lead cross-functional team to plan and implement changes and improvements to operational systems and processes. • Lead identification, discussion, and mitigation of project risks to successful completion of tasks and activities. • Document manufacturing and production development process through lab notebooks, engineering protocols, and engineering reports. • Perform research and integrate new technologies into existing and future products and processes. • Solve practical problems encountered. • Create and modify product design specifications. • If in a supervisory position, select, manage, train, and develop staff.
• Responsibility for the sustainable development and expansion of your sales territory • Building long-term partnerships with hospitals and interventional physicians in radiology, vascular surgery and cardiology • Clinical consultation and support for the use of our innovative Penumbra products • Independently executing product launches and delivering presentations to users and procurement • Strategic analysis and further development of existing accounts as well as identification of new market opportunities • Establishing and maintaining close relationships with relevant decision-makers and key opinion leaders • Implementing regional sales and marketing strategies with a high degree of autonomy • Assisting with interventional procedures and providing support directly in the clinical setting • Representing Penumbra at conferences, workshops and professional events • Close collaboration with cross-functional teams at national and European levels
• Conduct field medical visits in collaboration with distributors, ensuring consistent education and awareness of Penumbra products. • Plan, organize, and operationalize hands-on sessions, workshops, and in-hospital product training for distributors and healthcare professionals. • Act as the primary field support for distributor activities, ensuring alignment with Penumbra’s commercial and clinical strategies. • Support the implementation of product launches in your assigned region by working directly with distributors to drive product adoption and penetration in key accounts. • Gather and report market intelligence from the field to the Country Manager, identifying opportunities, challenges, and competitor activity. • Maintain effective communication and partnership with distributors to ensure consistency in messaging, training, and execution. • Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans.
• Provide key support to the Clinical Research Department for Penumbra clinical trials • Act as a core liaison between the Clinical Research and Legal Departments within Penumbra • Lead the process of clinical study budget negotiations with the clinical study sites (e.g., hospitals) for multiple clinical studies • Develop, review, and negotiate budgets and amendments for clinical trial sites • Serve as a primary point of contact between the Clinical Research and Legal teams by submitting contract requests for clinical and investigator-sponsored studies • Provide management with regular updates on site start-up progress and strategic implications • Identify and communicate any potential or actual delays, recommending solutions to keep projects on schedule • Maintain ongoing communication with clinical project managers and study teams to provide timely status updates • Proactively identify potential issues that may arise with budget and contract negotiations and propose potential solutions or options • Provide training and support for complex budget topics to junior team members • Identify and participate in ongoing process improvement initiatives when appropriate • Partner closely with the Legal team to manage timelines and expectations for new and changing clinical studies on a regular basis • Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures • Ensure other members of the department follow the QMS, regulations, standards, and procedures
• Increase peripheral embolization product sales and customer satisfaction within the assigned territory. • Work with the Regional Sales Manager on a daily basis to ensure superior customer service and peripheral embolization product use. • Strive to meet and exceed the quarterly and annual sales plans. • Develop relationships with existing hospitals, labs, and customers. • Prospect and develop relationships with prospective customers and/or users of Penumbra peripheral embolization products, converting them to Penumbra customers. • Secure and/or renew existing orders by coordinating product availability, delivery dates, and inventory levels. • Maintain open communication lines with current and prospective customers on programs, promotions, and pricing trends. • Increase account penetration with orders for new and existing line of peripheral embolization products and services. • Develop relationships with physicians, lab staff, lab supervisors, and purchasing personnel. • Commit to travel multiple days/nights per week for position and peripheral embolization product line support. • Maintain accurate record of sales expenses, customer files, and field sales reports required, communicating required information as needed.
• Coordinate end-to-end marketing literature approval process (ECO) across all EMEA submissions • Own ECO approval workflows for marketing literature across Marketing, Legal, Clinical, and Regulatory teams, ensuring compliant, high-quality, and timely execution through structured multi-step review processes • Monitor workflow execution across stakeholders and systems, proactively resolving bottlenecks and ensuring smooth end-to-end process flow • Coordinate marketing materials ordering and management processes across EMEA with 3PL partners, including inventory, forecasting, procurement, logistics, and demo materials operations (shipping, tracking, inventory control) • Maintain and support key systems (SAP, Sales Portal, Veeva, ordering tools), including user support, operational coordination, and documentation management • Ensure process consistency, compliance, and continuous improvement through structured documentation and material handling governance • Support cross-functional operations including vendor/3PL coordination, product launches and discontinuations, and occasional on-site support for vendor-related or customer-facing events (KPI reviews, customer/event support); act as backup for Senior Marketing Operations Coordinator
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