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- ...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
- ...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 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$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 - $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 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$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- ...management systems Additional Preferences: Knowledge of US and international regulations, guidelines, and other compendia (e.g., FDA, EMA, ICH, PIC/S) Quality auditing certification (e.g., ASQ Certified Quality Auditor (CQA) or equivalent) is a plus Experience with...SuggestedFull timeWork experience placementWork at officeVisa sponsorshipWork visa
- ...quality strategy, ensuring alignment with corporate objectives and regulatory requirements. Ensure site adherence to GMP, ISO 13485, FDA, EMA, and other applicable regulations for medical device, drug packaging and combination products. Direct Quality Assurance, Quality...SuggestedWork experience placementLocal areaWorldwideFlexible hoursShift work
- ...quality strategy, ensuring alignment with corporate objectives and regulatory requirements. Ensure site adherence to GMP, ISO 13485, FDA, EMA and other applicable regulations. Lead Quality Assurance, Quality Engineering, Quality Systems, and Quality Program teams. Maintain...Work experience placementWorldwide
$62.23k
...focuses on adolescents (ages 13-20) and employs a longitudinal design, passive data collections, and ecological momentary assessments (EMA) to capture the dynamic nature of symptoms. The position involves engaging with multi‑level datasets and contributing to statistical...- ...Supply Chain Security Act (DSCSA) requirements. Support internal compliance with applicable regulatory requirements (e.g., FDA, MHRA, EMA, ICH, etc.) Collaborate with internal departments in addressing regulatory topics and provide guidance as needed. Assist with...Full timeTemporary workWork experience placementWork at officeRemote work
- ...conditions and measurement uncertainties. Maintain calibration databases and ensure IQ/OQ/PQ compliance. Execute activities per FDA, EMA, and ICH guidelines with 21 CFR Part 11 compliance. Develop calibration procedures and establish intervals based on drift analysis....Daily paidFull time
*US AMR-Jones Lang LaSalle Americas, Inc.
Bloomington, IN1 day ago $25 per hour
...Microsoft Office Suite (Word, Excel, PowerPoint) and document management software. # Familiarity with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GCP, GMP) preferred. # Excellent communication and interpersonal skills, with the ability to...Work at officeDay shiftUrsitti Enterprises LLC
Portage, IN22 days ago- ...variability, and limitations Strong understanding of: CMC development and commercialization, GMP and global regulatory expectations (FDA, EMA, ICH), OOS/OOT investigation frameworks and industry best practices Demonstrated ability to: influence cross-functional teams...Local area
$80k - $90k
...sensitivity, selectivity). Quality & Compliance Ensure compliance with GLP, GCP, 21 CFR Part 11, and relevant regulatory guidance (FDA, EMA). Serves as Test Site Management for reports, audits, and investigations, as applicable. Support audits (internal, client,...Contract workTemporary workWork at officeLocal areaRemote workDay shift- ...skills, and behavior modification approaches Maintain cleanliness of center Adhere to policies and procedures provided by the EMAS Policy Manual Provide a safe and engaged environment for clients Independent problem solving to improve efficiency and self-growth...Full timePart timeMonday to FridayFlexible hours
Engaging Minds Autism Services
Kokomo, IN19 days ago - ...proteins Essential Experience with technology transfer and GMP manufacturing technical support Essential Experience with EMA/FDA regulations, ICH guidelines, GMP and quality systems Essential Effective communicator with track record of presenting data...Temporary workFor contractorsWork experience placementLive inVisa sponsorship
Genezen
Indianapolis, IN13 days ago - ...associated data integrity requirements Excellent working knowledge, understanding, and experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control Exceptional computer skills evidenced by hands-on work with...Full timeShift workNight shift
- ...trials Essential Familiarity of eQMS systems such as Veeva Desired Knowledge of clean room controls, aseptic processing, and EMA and ISO standards for cleanrooms Desired Knowledge of cGxPs, clean room controls, aseptic processing, and EMA and ISO standards...Work experience placementLive inVisa sponsorship
- ...preferred). Demonstrated experience leading large-scale C&Q efforts and cross-functional project teams. Familiarity with GMP, FDA, EMA, and ISPE guidelines; strong working knowledge of ASTM E2500 and risk-based verification approaches. Proficiency in project and...Full timeFor contractors
- ...product quality and regulatory compliance. Regulatory Compliance & Inspection Readiness Ensure compliance with cGMP, GLP, FDA, EMA, and applicable regulatory requirements. Serve as primary SME during regulatory inspections and client audits for analytical and QC...Live inVisa sponsorship
$163.5k - $239.8k
...in environments where influence matters more than direct authority. Experience engaging with global health authorities (e.g., FDA, EMA, PMDA) during regulatory inspections and lifecycle submissions for parenteral drug products. Deep familiarity with technology...Full timeContract workTemporary workRemote workWork from homeMonday to FridayFlexible hours- ...compassionate, and able to perform effectively in fast-paced and challenging environments while working collaboratively with Fire, Police, EMA, hospital staff, and other healthcare professionals to deliver exceptional patient care. Requirements: PRN High School...Relief
Adams Memorial Hospital
Decatur, IN4 days ago
