Delcath Systems Inc

Role Description The Medical Affairs Coordinator will support the planning, execution, and tracking of key Medical Affairs initiatives across the organization. This role will work cross-functionally with Medical Affairs, MSLs, Clinical, Commercial, Regulatory, and external partners to ensure operational excellence across programs, congress planning, evidence dissemination, advisory boards, investigator-initiated trials (IITs) and data generation. The position will also support cross-functional harmonization with ongoing and future medical affairs programs involving Europe. Qualifications - Undergraduate degree (BA/BS) in physical sciences, life sciences, or engineering is preferred. - 2–5 years of experience in pharma/biotech, clinical research, or Medical Affairs support. - Strong organizational and project management skills. - Project management experience is preferred especially in Small Pharma or Biotech. - Experience managing multiple cross-functional projects toward successful completion in virtual/hybrid environments is required. - Excellent communication and cross-functional collaboration skills. - Experience with tools such as Excel, PowerPoint, and project management platforms (e.g., Smartsheet). Requirements - Support day-to-day coordination of Medical Affairs programs and initiatives. - Track timelines, deliverables, and milestones across multiple projects. - Ensure alignment across internal stakeholders (Medical, Clinical, Commercial, Regulatory). - Maintain dashboards and reporting tools (e.g., Smartsheet, Excel trackers). - Support vendor coordination and documentation (e.g., confidentiality agreements, reprints, contracts). - Ensure documentation is organized and audit-ready. - Support logistics related to IIT study start-up, including kit ordering, shipment coordination, and site readiness. - Serve as a point of contact for operational aspects of IIT execution (e.g., material supply, documentation, timelines). - Coordinate and ensure the timely execution of all pre-meeting, meeting, post-meeting, and archiving activities related to advisory boards and scientific meetings in collaboration with in-house medical affairs and strategy. - Routing invoices, honoraria, and reimbursements for KOLs (Ad Board participants). - Managing new vendor setup, contracts, and invoice payments within Medical/Translational. - Coordinate pre-, during-, and post-congress activities. - Track deliverables across MSLs and internal teams. - Assist with KOL engagement planning and tracking. - Maintain and update IIT and research trackers. - Coordinate IIT contracting processes in collaboration with Legal, Finance, and external institutions. - Coordinate internal review processes and documentation (e.g., SRC, budgets, contracts). - Support communication with investigators and internal stakeholders. - Track study progress, enrollment, and key milestones. - Support, maintain, and co-manage the Data Generation Plan and Tracker in collaboration with Medical Research & Strategy. - Ensure the timely execution of data generation programs (IITs/RWE) by coordinating many of the key steps necessary from “concept to final publication” for ongoing and new projects. - Support, maintain, co-manage the Data Dissemination Tracker and timelines in collaboration with the Lead for Medical Strategy and Data Dissemination/Education. - Provide operational support of publication planning and timelines for scientific meeting abstracts, submissions, correspondence(s), authorship compliance/contracting, and final deliverables in collaboration with the Lead for Medical Strategy. - Support, maintain, and co-manage the Education and Information Tracker in collaboration with the Lead for Medical Strategy and Data Dissemination/Education. - Support Scientific Response Letter (SRL) and Medical Information workflows. - Develop, implement, and co-manage the Engagement/Insight Gathering Field Tracker in collaboration with the field and in-house medical affairs team (directors and MSLs) to ensure timely execution of strategic engagement, actionable insights, key performance indicators. - Coordinate MSL activities tracking and insights consolidation. - Assist in capturing and organizing field insights. Company Description

Role Description We’re looking for a motivated and collaborative Senior Manager, Regulatory Affairs, CMC to join our growing team at Delcath. In this role, you’ll have the opportunity to make a meaningful impact while working alongside talented colleagues in a supportive and innovative environment. The Senior Manager, Regulatory Affairs, CMC is responsible for executing the day-to-day tactical activities of CMC regulatory submissions, with specific emphasis on compiling and submitting regulatory submissions. The Senior Manager, Regulatory Affairs shall provide direct regulatory submission support for NDA/IND for our oncologic drug/device combination product that is regulated as a drug. Essential Duties and Responsibilities - Must be familiar with the Quality Systems Registration under 21 CFR 820, Regulation of Combination Products 21 CFR 4, and EU Medical Device Regulation (MDR). - Must have knowledge of Investigational New Drug regulations under 21 CFR 312 and Applications for FDA Approval to Market a New Drug regulations under 21 CFR 314. - Must have device product experience; drug/device combination product experience a plus. - Must be familiar with FDA’s current thinking and guidance for industry. - Execute day-to-day processes for regulatory accountabilities to ensure continual regulatory compliance with FDA and MDR requirements. - Work closely with regulatory team and internal staff to prepare, review and submit international regulatory and domestic submissions, including NDA, IND and CTA supplements and amendments. - Assist in the preparation, review, and submission of annual reports, amendments, and supplemental applications to INDs, NDAs, and CTAs. - Monitor, review, and interpret new or revised regulatory requirements and proactively advise corporate disciplines. - Review and interpret technical and scientific data to ensure regulatory requirements are met; evaluate product/design and process changes for potential effect upon product safety and effectiveness; and appropriately document the regulatory disposition of such changes. - Other activities as assigned by management. Qualifications - A BS or MS degree in physical or life sciences required. - At least 5 years drug regulatory affairs experience in the pharmaceutical industry, with direct accountabilities related to Health Authority submissions and compliance related matters. - Direct working knowledge of FDA and International drug regulations. - Experience working across multi-disciplinary levels, functions, and regions is required. - Team oriented, with the ability to work well with diverse cross-functional teams. - Strong analytical and process skills; computer proficient in EXCEL, MS Project, PowerPoint, Word, etc. - Strong verbal and written communication skills. - Willingness to travel. Requirements - Must be able to read and interpret technical documents. - Must be able to effectively write routine reports and correspondence. - Must possess the ability to speak effectively with employees and outside organizations. - Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. - Ability to compute rate, ratio, and percent and create and/or interpret spreadsheets and graphs. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - Regularly required to sit, stand or walk and talk or hear. - Frequently required to use hands to finger, handle, or feel and reach with hands and arms; subject to repetitive motions of the wrists, hands, and/or fingers. - Occasionally lift and/or move up to 10 pounds. - Specific vision abilities required include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.