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- ...qualification of CUB systems in alignment with site master plans and regulatory expectations. Ensure all utility systems comply with GMP, FDA/EMA, and local regulatory requirements. Coordinate and integrate workstreams with process engineering, operations, quality, EHS,...SuggestedContract workLocal area
- ...schedules with key pharmaceutical milestones (e.g., IND, clinical phases, NDA/BLA). Ensure adherence to relevant regulations (FDA, EMA, GCP, GMP) and Aniesispharma's quality standards. Maintain comprehensive project documentation compliant with pharmaceutical industry...SuggestedRemote jobWork at office
- ...Finance on budgeting, forecasting, cost optimization Compliance & Quality Ensure all clinical supply activities comply with GxP, ICH, FDA, EMA, and global regulatory requirements Lead inspection readiness activities for global filings Team Leadership Build, lead, and mentor a...Suggested
- ...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workFlexible hours
- ...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workFlexible hours
- ...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workTemporary workImmediate startFlexible hours
- ...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workInterim roleImmediate startRemote workFlexible hours
- ...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workInterim roleLocal areaImmediate startRemote workFlexible hours
$47k - $79.9k
...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workLocal areaRemote workFlexible hours$120k - $135k
...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workWork at officeImmediate startRemote workWorldwideFlexible hours$79.8k - $139.6k
...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workImmediate startRemote workFlexible hours$20.38 per hour
...commuting distance of the facility location. If required to provide own vehicle, ARC will receive an Equipment Maintenance Allowance (EMA). Work is performed indoors and outdoors in all types of weather. Carriers may be required to load and unload trays and containers of...SuggestedBi-weekly payHourly payWork at officeWorldwideWeekend workWeekday workUnited States Postal Service
Wisconsin5 days ago$95k - $175.7k
...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workRemote workFlexible hours2 days per week3 days per week$80.6k - $145k
...Prior involvement in CAR-T or other cell therapy studies is highly desirable. ~ Strong familiarity with GCP/ICH guidelines , FDA/EMA regulations, and inspection-readiness standards. ~ Experience working in sponsor-dedicated or embedded roles within a CRO is a...SuggestedFull timeContract workWork experience placementWork at officeRemote workFlexible hours$114k - $210.9k
...the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll...SuggestedContract workRemote workWork from homeFlexible hours2 days per week3 days per week$130k - $150k
...Support responses to regulatory agency questions and inspections. Ensure analytical activities comply with applicable GMP, ICH, FDA, EMA, and other regulatory requirements. Participate in quality investigations, change controls, risk assessments, and CAPA activities...Contract workArrowhead Pharmaceuticals
Madison, WI13 days ago- ...independently while recognizing when to consult your supervising physician. Become proficient in managing a patient load of 30+ per day using EMA, our Electronic Health Record. Provide guidance and direction to clinic staff as needed. Qualifications A minimum of 2-5 years of...Full timeLocal areaFlexible hours1 day per week
$85k - $95k
...qualification activities. Working knowledge of 21 CFR Parts 210/211, ICH Q7, and applicable global regulatory expectations (e.g., FDA, EMA, Health Canada), along with familiarity with relevant regulatory guidance documents. Preferred Prior experience with use of an...Work at office$85k - $95k
...Quality Management. Working knowledge of 21 CFR Parts 210/211, ICH Q7, and applicable global regulatory expectations (e.g., FDA, EMA, Health Canada), along with familiarity with relevant regulatory guidance documents. Preferred : Prior experience with use of...Contract workWork at officeArrowhead Pharmaceuticals
Madison, WI8 days ago$180k - $210k
...or a related field. Experience supporting or preparing for pre-approval inspections (PAI) or commercial GMP inspections by FDA or EMA. Experience with electronic QMS platforms (e.g., Veeva QualityDocs, TrackWise, or equivalent). Experience in biologics or RNA-based...Contract work- ...environments. The CSV Engineer will author validation deliverables—including protocols, reports, and SOPs—ensuring compliance with FDA, EMA, and global regulatory expectations. Key Responsibilities: Develop and maintain Design Specifications (DS) for computerized...Full timePart timeFlexible hours
$145k - $165k
...validation strategy, inspection readiness, and compliant system administration, ensuring alignment with global regulatory requirements (FDA, EMA, MHRA, ICH) and evolving industry standards (GAMP 5, CSA). This leader serves as a key partner to Manufacturing, Quality, CMC, CSA...- ...technical skills and performance of department members Assure all QC functions and testing are being performed according to FDA, EMA, ICH and other international regulations, as deemed necessary Supporting regulatory information requests from customers as it pertains...
PCI Pharma Services
Madison, WI3 days ago - ...EMA MKE HOTEL OPERATOR LLC in Milwaukee is seeking a reliable Night Auditor to manage the front desk during the overnight shift. The successful candidate will handle guest check-ins and check-outs, complete daily financial tasks, and maintain operational efficiency. Proficiency...Night shift
EMA MKE HOTEL OPERATOR LLC
Milwaukee, WI5 days ago - ...experience with data annotation, data quality evaluation, or AI training workflows Familiarity with regulatory submission standards (FDA, EMA, ICH, or similar) Background in clinical data management, bioinformatics, or health informatics Experience designing or...Hourly payOngoing contractContract workFreelanceRemote workFlexible hours
Alignerr
Milwaukee, WI3 days ago - ...environments. Confident presenter, comfortable interfacing with senior executives . Experience interacting with regulatory agencies (FDA/EMA) and key opinion leaders (KOLs) . Proven leadership and team management skills — able to mentor and motivate high-performing teams....
Cytel
Madison, WI3 days ago
