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Compliance Specialist
3 weeks ago
REMEDI8 Houston, United StatesWe are currently seeking a remote compliance specialist to join our team. As a compliance specialist, your primary responsibility will be to ensure that our company is operating in accordance with all relevant laws, regulations, and industry standards. You will work closely with ...
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Compliance Specialist
2 weeks ago
Spring Branch ISD Houston, United StatesCompliance Specialist - Multilingual Department - School Year · - JobID: 6807 · - Position Type: · Paraprofessional/Clerical · - Date Posted: · 5/8/2024 · - Location: · Multilingual Department · **Spring Branch Independent School District** · **_Compliance Specialist - Multiling ...
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Compliance Specialist
2 weeks ago
YES Prep Public Schools Houston, United States**POSITION**:Compliance Specialist · **REPORTS TO**:Mgr - Campus SPED or Principal, and Director of Special Education · **POSITION TYPE**:10-month · **START DATE**:24-25 School Year · **COMPENSATION**:$54,000 - $67,143 · At YES Prep, work for a mission that impacts the life traje ...
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Customs Compliance Specialist
6 days ago
NOV Inc. Houston, United States**Job Requisition: U.S. Customs Compliance Specialist** · **Key Responsibilities**: · - **Policy & Procedure Implementation**:Implement NOV's customs compliance policies & procedures across all relevant departments, ensuring adherence to regulations and minimizing the risk of non ...
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Compliance Specialist 503b
6 days ago
Empower Pharmacy Houston, United StatesPosition Summary: · Elevate the standards of pharmaceutical compliance and ignite your career as a 503B Compliance Specialist at Empower. In this role, you will be at the forefront of overseeing and enforcing adherence to critical regulatory frameworks, including those governed b ...
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Safety Compliance Specialist
6 days ago
Del Corona & Scardigli USA Houston, United StatesSafety Compliance Coordinator needed for transportation/trucking company. · **Job Description**: · - Set Up and Maintain New Driver Files (DQ Files) and Truck Files per FMCSA standards. · - Onboarding new drivers and owner-operators via training and orientations. · - Knowledge of ...
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Regulatory Compliance Specialist
5 days ago
Westlake Careers Houston, United States**SUMMARY** · The Regulatory Specialist supports the Polyethylene Business by carrying out activities pertaining to all aspects of regulatory compliance involving Westlake's Polyethylene and Epolene products. This job requires knowledge of, and the ability to interpret, United St ...
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Specialist, Compliance Training
3 days ago
Houston Community College Houston, United StatesWe are currently seeking a Specialist, Compliance Training who will advance the institution's proud tradition of excellence in academics, student life and community service. · **Job Summary** · Design and deliver training content geared toward specific areas of learning that may ...
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VESTA MANAGEMENT TX Houston, United States: · Welcome to **_55Fifty at Northwest Crossing_**, a Vesta community in **_Houston, TX_**. We are seeking to hire an experienced **Compliance and Leasing Specialist** · Essential Functions: · Reasonable accommodations may be made to enable individuals with disabilities to perfor ...
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Compliance Specialist
1 week ago
Upbring Katy, United StatesOverview: · **About **Upbring** · At Upbring, **we are servants** on a mission to break the cycle of child abuse. **We are warriors**, brave as the thousands of Texas Children and families we serve. We stand up for those who can't speak for themselves. **We are a family** who val ...
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Compliance Specialist
1 week ago
Brazos Valley Schools Credit Union Katy, United States**Role**: · Using attention to detail and knowledge of relevant laws and regulations, the Compliance Specialist helps ensure the Credit Union remains compliant with all applicable rules, regulations and laws. The Compliance Specialist works as a key part of the team to create a p ...
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Compliance Specialist
2 weeks ago
Adaptive Construction Solutions Houston, United StatesCompliance Specialist · Adaptive Construction Solutions - Houston, TX · Job Title: Compliance Specialist · Job Summary: · The Compliance Specialist will be responsible for managing and ensuring compliance with all prevailing wage laws and regulations for construction projects ...
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Compliance Specialist
2 weeks ago
Highmark Residential Llc Houston, United StatesOverview:Location:Houston, TexasWhy Highmark Residential?Because every position is considered critical to Highmarks success and reputation, we take care to employ those who aspire to become the best in their field. Those who succeed at Highmark will do so because they enjoy an em ...
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Compliance Specialist
2 weeks ago
WorleyParsons Houston, United StatesJob Description - Compliance Specialist (HOU03M5) · Compliance Specialist · - · HOU03M5 · Company · : · Worley · Primary Location · Primary Location · : · USA-TX-Houston · Job · Job · : · Compliance · Schedule · Schedule · : · Full-time · Employment Type · : · Empl ...
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Compliance Specialist
1 day ago
Highmark Residential Llc Houston, United StatesOverview:Location:Houston, TexasWhy Highmark Residential?Because every position is considered critical to Highmarks success and reputation, we take care to employ those who aspire to become the best in their field. Those who succeed at Highmark will do so because they enjoy an em ...
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Compliance Specialist
2 weeks ago
Empower Pharmacy Houston, United StatesCompany Overview · Empower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing fac ...
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Compliance Specialist
2 weeks ago
Empower Pharmacy Houston, United StatesCompany OverviewEmpower is a visionary healthcare company committed to providing quality, affordable medication to millions of patients across the nation. We hold the distinguished position of being the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facilit ...
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Compliance Specialist
3 weeks ago
Chord Energy Houston, United StatesThe Compliance Specialist will be responsible for submitting critical documentation and requests to state and federal agencies to ensure regulatory compliance in support of oil and gas operations. Duties will include regulations, submitting documentation to agencies, and regulato ...
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Compliance Specialist
2 weeks ago
WorleyParsons Ltd Houston, United States51,000 people. 49 countries. Over 120 office locations. · We're not just engineers. We're a global team of data scientists, consultants, construction workers and innovators all working to create a better tomorrow. Every day, we help customers in energy, chemicals and resources ge ...
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Compliance Specialist
1 week ago
EverLine - Energy's Technical Stack Houston, United StatesPosition Summary:The Principal Integrity Regulatory Specialist will report to the Director of Integrity Management and take an active role in managing the several operators asset integrity programs throughout the oil and gas industry. This individual will possess a comprehensive ...
Senior Regulatory Compliance Specialist - Houston, United States - Houston Methodist
Description
At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH).
This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases in accordance with appropriate regulations, Standard Operating Procedures (SOPs), and study specific protocols/plans and processes.
The Sr Regulatory Compliance Specialist position maintains documentation for clinical research studies, case report forms and study and regulatory files.
Under minimal supervision from the Manager or Director, this position identifies problem-solving issues of moderate to complex scope.The Sr Regulatory Compliance Specialist position contributes directly to internal departmental monitoring and research education as identified by the Manager or Director.
PEOPLE ESSENTIAL FUNCTIONS
Collaborates with cross-functional teams including key study personnel. Role models strong, positive communication skills to ensure cohesive, smooth operation of the department
Assists in training regulatory personnel and others on regulatory and safety reporting regulations, processes, and procedures under the direct supervision of the Regulatory Compliance Manager (serves as a resource for regulatory information and guidance)
Develops and maintains interpersonal relationships with a wide variety of healthcare professionals and hospital leadership. Maintains credibility with IRB and other regulatory agencies, Sponsors, vendors, patients, and co-workers
Role models behaviors that are congruent with cultural diversity, equity, and inclusion principles. Initiate's improvement recommendations for department scores for employee engagement, i.e., peer-to-peer accountability
SERVICE ESSENTIAL FUNCTIONS
Serves as subject matter expert in support of department functions. Defines problems, collects data, establishes facts, and draws valid conclusions and evidence-based performance improvement via measurable results
Prepare and manage documents required to initiate investigational drugs trials.
Prepares research protocols for IRB submission, submits protocol amendments, prepares renewals and necessary regulatory documents for submission to study sponsors.
Submits adverse event reports, safety reports, and notifies IRB of study closuresInterfaces as needed with appropriate governmental agency on project/products as identified by the Manager. Assists in the preparation of periodic reports for FDA
Develops appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes under the direct supervision of the Regulatory Compliance Manager
QUALITY/SAFETY ESSENTIAL FUNCTIONS
Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA, GCP, NIH and applicable regulations. Provide routine updates and reporting to the Regulatory Compliance Manager to ensure timely communication regarding status of regulatory and/or important safety related issues
Conducts internal reviews and audits to ensure compliance of regulatory forms and associated documentation
Serves as a liaison between the institutional review committees, regulatory agencies, and the investigators to ensure that protocols are approved, and that supplementary information is provided in a timely fashion as requested
FINANCE ESSENTIAL FUNCTIONS
Utilizes resources with cost effectiveness and value creation in mind.
Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis.
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned.
EDUCATION
Bachelor's degree or higher
Master's degree preferred
WORK EXPERIENCE
Five years of experience in relevant research program experience
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Senior Regulatory Compliance Specialist professionals in Houston
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Rick Neudorff
Business Continuity & Emergency Management Dir.