Careers

The Regulatory Specialist is responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable drug regulations, guidance, and standards (US/North America). Assist in creation and maintenance of regulatory files. Key Responsibilities: Write, analyze, and edit technical documents to support regulatory submissions and compile submissions, including IND and NDA submissions in the USA. Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. Maintain regulatory files. Maintain and update regulatory documents, such as INDs and NDAs. Assure that appropriate maintenance of registrations occurs including renewals, drug listings, site registrations, supplements for changes, and annual reports. Support approval in other regions as required. Assist in preparing responses to regulatory authorities’ questions within assigned timelines. Stay abreast of regulatory procedures and changes in regulatory climate. Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance. Perform as a member of the Change Control Board to identify regulatory impact and required regulatory reporting/submission for proposed changes. Other duties as assigned.

General Summary: The Sr. Statistical Programmer will be responsible for statistical programming support for clinical trials and programs including submissions to Health Authorities. The position will also support in-house ad hoc programming requests (e.g. for abstracts or publications).   Job Duties and Responsibilities:  Collaborate with biostatisticians, data managers, and clinical study teams to ensure the accurate and timely delivery of data and analysis results on assigned studies and programs. Serve as the primary point of contact for statistical programming, coordinate outsourced programming activities. Oversee outsourced statistical analysis and reporting deliverables (e.g. safety, efficacy analysis datasets, tables, listings and figures) to ensure compliance with industry standards (CDISC, SDTM, ADaM) and applicable regulatory guidelines. Ensure data packages for health authority submissions comply with applicable submission requirements. Maintain statistical datasets that will support clinical development and safety. Provide statistical programming support for ad-hoc requests (e.g. abstracts, posters, publications etc.)

Position Summary:  The Sr. Clinical Research Associate will oversee outsourced clinical operations activities including but not limited to site management, site monitoring and site level TMF filing. Additional responsibilities may be assigned (e.g. management of central labs). Job Duties: Oversee outsourced clinical trial monitoring by reviewing monitoring plans, monitoring visit reports, deviation listings, and conducting periodic oversight monitoring visits. Review site training materials including Site initiation visit slides and related materials.  May attend / present at site initiation visits (e.g. present company overview and pipeline slides). Develop or oversee development of study / country master ICFs; facilitating internal reviews as appropriate and applicable. Review subject facing documents (e.g. subject ID cards, subject instruction material) for accuracy against the protocol, IB, consent and other documents as applicable. Oversee site management activities by:Ensuring sites are compliant with GCP, and CROs are appropriate and timely escalation of deviations or non-compliance etc. Serve as primary point of contact for the CRO regarding site level issues. Review site level documents as relevant, e.g. site recruitment plans, site level ICF changes (including facilitation of internal review where appropriate). Ensuring timely collection /submission of updated regulatory documents and that TMF site files are in an inspection ready state. May also conduct or assist with study and country level TMF QC. Track distribution of safety letters to site. Escalate deviations from regulatory timelines to Clinical Project Manager. In coordination with other clinical team members, ensure study data quality by:Ensuring timely data entry and query resolution by sites. Serve as primary escalation point for late data entry / query resolution or lagging source data verification percentage. Support internal clinical data review process (e.g. review data for accurate subject disposition). Action follow-up items as applicable after internal data review meetings (e.g. schedule calls or follow-up with sites where additional discussion may be required). Provide updated site level documentation and applicable updates to regulatory as appropriate (e.g. updated 1572s, communicating site activations/site lists). Contribute to development of vendor oversight plans for outsourced clinical operations activities.

Job Duties: Project Stage Priority: Facility buildout complete ProjectOn-site supervisor for completion of facility: cleanrooms/labs, office renovation, hot cells Support the installation/qualification of mechanical/HVAC, electrical, plumbing, cleanrooms, hot cells, fume hoods/isolators, control systems, BMS, fire safety, etc. Heavy emphasis on HVAC/cleanrooms/BMS Liaison with service providersPrimary point of contact; supervise on-site work Obtain competitive quotes, select vendors, negotiate pricing, approve POs/vendor bills, cultivate relationships Manage contracts (e.g., pest control, fire monitoring/suppression, landscaping/snow, equipment PM/repair, custodial services) Assist withSafety programs: radiation, laboratory, occupational Facility licensing/compliance: RAM, effluents/emissions, sewer water/storm water, building codes (fire/electrical) Cleanrooms: Participate in cleaning, IQ/OQ/PQ Establish a system for scheduling/recording: warranties, inspections, PMs, repairs Production Stage Priority: Facility ready to produce GMP doses Continue tasks above, as needed On-call to react to alarms/emergencies/urgent facilities problems that might cause production delays Production area: Ensure safety and readiness Inspections/PM/repairs of facilities-related equipment: In-house or supervise contractors (e.g., emergency showers/eyewash, fire sprinklers/extinguishers, emergency alarms/systems, backup power transfer) Facilities equipment: Manage warranties, service contracts; schedule PMs, requalification Documents for facility: Draft/review SOPs, IQ/OQ/PQ, other protocols/reports Maintain a stock of spare parts/other supplies Assist with budget forecasting of CapEx/OpEx Waste management: RAM, chemical, garbage, recycling Assist with investigations for Quality Unit (deviations/OOS/recalls/FMEAs) Facility renovations/expansions: planning, bidding, selection/contracting, design, project management All Stages Frequent facility inspections inside/outside[HE(C5]  Expert on the facility for inspectors/management/staff Review/approve documents: quotes/contracts, PMs, final reports, invoices Manage badge access system Attributes o Character to exemplify: integrity, team spirit, service attitude, initiative, problem solving, attention to detailEmbody a culture of safety, quality, continuous improvement, customer service Press toward ambitious goals/timelines; motivate colleagues Comply with SOPs, policies, regulations, laws Represent employer well at all times Location: On-site 100%; Travel <10% Other tasks/responsibilities as needed

Orano Med is seeking a Sr. Analyst, QC or Analyst, QC for ATLab Indianapolis (ATLab IND), a new, state-of-the-art facility for commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals. The top priority for this position will be QC testing for same-day batch release. This position offers the opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability. Setup Phase: Training: SOPs, safety (radiation, industrial), on-the-job training for QC methods Assist with IQ/OQ/PQ of new equipment and instrument software; supervise/learn from field engineers when they are on-site. Draft/review of documents: SOPs, Forms, FMECA, tech transfer protocol, analytical method validation protocols QC methods: tech transfer, implementation, improvements, full validation Production Phase: Top Priority: QC testing for batch release within hours of production Routine Functions All tasks from the Setup Phase that continue into Production Phase. Safety: Follow EHS regulations/guidelines, incl. NRC (ALARA), OSHA, EPA, chemical, waste disposal, etc. Adhere to SOPs, cGMP requirements, company policies, regulatory requirements Regulatory compliance: maintain constant readiness for inspection Maintain status as a qualified operator for all QC procedures Day-of-use setup before QC testing: Verify calibration/qualification status of instruments Gather raw materials and confirm not expired System suitability testing of instruments Testing:Chemistry QC: raw materials, APIs, in-process materials, finished drug products Microbial: VPHP, inoculation of drug product, incubation/inspection of samples for EM/sterility testing Carefully complete documentation: paper/electronic QC test records, equipment logs, other records, perform technical review of completed documents Equipment: lookout for failures/concerning trends; report problems; troubleshoot if possible Materials: Help receive deliveries; obtain documentation for raw material acceptance; perform in-house testing; coordinate 3rd party testing Help maintain backup supplies for QC: spare parts, consumables, PPE, other supplies Waste disposal and cleaning of QC lab Help recruit/train new employees Continuous Improvement: Embody and promote a culture of quality and continuous improvement Strive toward ambitious goals/timelines Draft/review SOPs and other documents Assist with Quality Events (deviations, OOT/OOS, CAPAs, change controls, recalls, complaints, FMEAs, audits, inspections, investigations) Assist with repeating equipment qualification and/or method validation as needed Location: On-site 100% This position may receive other responsibilities as needed.

The Safety Lead manages the Radiation Safety, Chemical Safety, and Environmental Health & Safety programs and serves as the subject matter expert for safety regulations impacting the various departments.  Duties include developing policies and procedures in accordance with applicable regulatory entities. Primary Job Duties:  Radiation Safety Formulates, prepares, and implements the Radiation Safety Policies and Procedures. Implements the Radiation Worker Training program and provides Radiation protection oversight. Trains employees on radiation safety procedures. Reviews and maintains historical record of area surveys. Tracks, trends and reports radiation exposure of employees and area radiation surveys. Manages employee radiation exposure badges and electronic dosimeters Maintains inventory of radioactive materials (RAM), RAM receipt documentation, RAM shipping documentation and usage logs. Performs periodic equipment and sealed source checks to comply with applicable regulations. Regularly inspects facility and audits practices for radiation safety compliance, addressing any concerns promptly. Maintains DOT and Hazmat certification for compliance with radioactive material shipments – domestic and international. Chemical Safety Formulates, prepares and implements the Chemical Hygiene Plan to ensure regulatory compliance as mandated by local, state, and federal agencies. Formulates, prepares and implements chemical safety policies / programs such as proper chemical inventory, labeling & storage procedures, chemical material disposal, and chemical implications for fire protection. Ensures proper chemical or hazmat spill preparedness & clean-up supplies are kept in stock. Conducts routine and follow-up chemical safety and hazard inspections throughout the facility ensuring adherence to established procedures and proper operation of chemical hoods, eyewashes, safety showers and other emergency equipment. Responds to emergency situations involving hazardous materials, or fire and smoke incidents; prepares reports of findings and submits recommendations. Analyzes chemical accident and incident reports for trends; makes recommendations for correcting unsafe conditions and actions. Environmental Health & Safety Develop, manage & maintain the Environmental Protection, Safety, and Health plan. Perform process, jobs, and work site hazards analysis and reviews, and define the hazards controls to be integrated during planning activities, and implemented during process development, work instructions development, and work execution. Monitor and evaluate activities and work areas, and address safety issues and concerns with employees; provide feedback into the work processes of issues observed. Capture and report safety incident notifications, investigations, and the root cause. Track and report company Safety Key Performance Indicators. Maintain continuous improvement of the the Company's Safety Culture.

General Summary: The Sr. Manager of Clinical Quality will be responsible for building out and managing quality management infrastructure for the clinical development organization. The role will be responsible for leading process development, managing department training matrices, owning the CAPA and deviation process, coordinating contracted audits and driving inspection readiness activities. Job Duties and Responsibilities:  Provide oversight and management of the clinical quality management system including driving clinical process development and improvement, managing periodic review of department SOPs and department training matrices. Implement and manage the clinical process deviation and corrective and preventive action (CAPA) process. Implement periodic quality reviews with department leadership. Coordinate clinical QA audits including investigative site audits and service provider qualification audits. Maintain listing of audits conducted, obtain timely and adequate audit finding responses, scheduled requalification audits as appropriate. Maintain clinical quality related records (qualified service provider list, audit related documents). Oversee inspection readiness activities (set up of inspection hosting logistics, facilitating mock inspections, implementation of inspection related communication plans with external parties, driving storyboarding activities etc) and host / assist in hosting health authority GCP related inspections.

General Summary:   The Sr. Clinical Scientist will be responsible for designing clinical trials, contributing to data cleaning and analysis, contributing to regulatory submissions, collaborating with internal and external stakeholders, and providing scientific leadership.   Job Duties and Responsibilities:  Design clinical trials: Propose and ensure study designs are scientifically sound, feasible, and aligned with the clinical development strategy and any applicable regulatory requirements, advice and / or guidance. This includes defining eligibility criteria, selecting appropriate endpoints, and ensuring assessments are adequate to capture necessary data in support of endpoints. Author and/or contribute to clinical documents: Author clinical study protocols, contribute to clinical trial training materials (e.g Site Initiation Visit Slides), development of informed consent form and other patient materials, case report forms (CRFs) design, statistical analysis plans (SAPs) and clinical study reports (CSRs). Data Collection and analysis: Collaborate with clinical operations, biostatistics and data management teams to clean and analyze clinical trial data, interpret results, and prepare clinical study reports. Regulatory Submissions: Contribute to the preparation of regulatory documents, including Investigational New Drug (IND) applications, Investigator’s Brochures (IBs), and New Drug Applications (NDAs). Stakeholder Collaboration: Liaise with internal and external stakeholders, including investigators, key opinion leaders (KOLs), and regulatory authorities. Scientific Communication: May present clinical data and development plans to internal teams, external partners, and at scientific conferences. Medical Monitoring: May provide support for medical monitoring activities and/or serve as Medical Monitor for assigned trials.

General Summary: The Senior Manager of Safety Operations will oversee and manage the safety reporting operations in support of Orano Med clinical trials. This role ensures the accurate and timely collection, analysis, and reporting of safety data, in compliance with regulatory requirements and company policies. The ideal candidate will possess strong leadership skills, extensive knowledge of pharmacovigilance processes, and a deep understanding of clinical trial safety operations. Job Duties and Responsibilities:  Manage outsourced safety vendor(s) and processes to ensure compliance with contractual agreements and regulatory requirements. Ensure compliance with all relevant regulatory guidelines and requirements (e.g., FDA, EMA, ICH) related to clinical trial safety reporting including the accurate and timely entry of safety data into safety databases. Develop and track key performance indicators (KPIs) for the central safety vendor and clinical resource organizations (CROs) managing individual studies. Develop and maintain standard operating procedures (SOPs) and work instructions for oversight of outsourced safety operations. Put in place study level safety processes and safety reporting mechanisms (e.g. write safety management plans, oversee safety gateway set up and maintenance). Manage writing of safety reports, including periodic safety update reports (PSURs), Development Safety Update Reports (DSURs). Liaise with regulatory authorities regarding safety reporting and provide responses to safety-related inquiries. Lead initiatives to implement new technologies and tools to support safety data management and reporting. Stay current with industry trends, regulatory updates, and best practices in pharmacovigilance and safety operations.

Position Summary: This position will be responsible for overseeing the safety aspects of Orano Med clinical trials, ensuring patient safety, medical review of individual case safety reports, signal detection and contributing to authoring period reports and safety sections of relevant clinical documents. Job Duties and Responsibilities:  Oversee and manage the safety aspects of clinical trials and post-marketing surveillance. Ensure all safety activities comply with regulatory requirements and industry standards. Monitor and analyze safety data to detect safety signals and trends and take appropriate action. Prepare / review safety reports, including DSURs, PSURs, and other regulatory submissions. Provide medical review for individual case safety reports. Work closely with cross-functional teams, including clinical development, regulatory affairs, and pharmacovigilance, to ensure integrated safety management. Prepare consent form risk language, provide safety input into relevant clinical and regulatory documents (protocols, investigator brochures etc. Liaise with regulatory authorities, external safety committees, and other stakeholders regarding safety issues and updates.

Position Summary: The Sr. Manager, Records Management will be responsible for oversight of all study level Trial Master Files including set-up, periodic and final QC and final transfer and archival. The position will develop oversight and TMF archival SOPs and manage the TMF archival platform. Job Duties and Responsibilities:  Develop and implement a comprehensive records management strategy including oversight and archival SOPs and set-up and management of a TMF archival platform. Select and onboard/implement an archival TMF platform. Oversee the TMF archival process, ensuring that all documents are properly filed, indexed, and accessible. Ensure inspection readiness state for outsourced TMFs by conducting periodic quality control reviews and following up to ensure timely and appropriate resolution of findings. Prepare for and support health authority inspections (trial master file QCs, pulling documents during inspections. Stay current with regulatory requirements and industry best practices related to records management and TMF.

Position Summary: This role will be responsible for oversight of outsourced data management activities and be charged with developing data management oversight and data cleaning processes and a CRF library. Major Duties and Responsibilities:  Oversee outsourced data management activities by ensuring the design, development and maintenance of clinical databases meets regulatory requirements and industry standards and developing and monitoring key performance indicators (KPIs) for data management service providers. Ensure timely and appropriate reconciliation of external data sources against clinical databases on assigned studies. Collaborate with cross-functional teams including Clinical Operations, Biostatistics and Clinical Development to ensure high quality and on time delivery of study level data. Collaborate with internal stake holders to develop an internal data review process. Manage internal data review process and issuing / resolution of queries. Develop global CRF library for re-use on future studies to improve study database build timelines.

Orano Med: Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.   Job Description: Orano Med is searching for an energetic and highly motivated professional to participate in manufacturing of current Good Manufacturing Practices (cGMP) clinical products as GMP Production Associate. This position will perform functions related to production and GMP manufacturing operations, including preparation of clinical doses. This position requires great attention to detail, ability to work in a team environment and interest in optimization of processes. The GMP Production Associate will be responsible for adhering to Standard Operating Procedures (SOPs), cGMPs, and all safety requirements involving use of radioactive materials. Major Duties and Responsibilities: Perform radioactive isotope elution and chelation as part of GMP manufacturing according to written procedures. Maintain batch records, equipment logs, and other production records as directed per company procedures. Work concurrently with Quality Assurance personnel to deliver a quality product. Follow and adhere to production schedules and timelines. Execute room and equipment preparation for manufacturing operations. Maintain stock of manufacturing raw materials and obtain necessary documentation. Identify and communicate process failures during manufacturing. Identify common equipment/process failures and troubleshoot solutions for operational challenges. Assist in deviation investigations, corrective actions, and preventive actions. Clean, sanitize and sterilize equipment and components to support production operations. Perform room sanitization activities as needed to maintain controlled environment conditions.