Strategic Regulatory Expert for Clinical Trials
hace 24 horas
GSK seeks a highly skilled Strategic Regulatory Expert to lead the set-up and execution of regulatory strategies for clinical trials across all therapeutic areas. As a key member of our team, you will be responsible for providing support in achieving the Study Start-up process.
Responsibilities:
- Coordinate planning, start-up, and maintenance of regulatory operational activities involved in clinical studies
- Apply deep technical expertise and understanding of local regulatory environment to drive delivery of business objectives
- Work closely with local teams to ensure accurate planning, prioritization, anticipation, and mitigation of risks
- Prepare and review documentation required for regulatory processes (e.g., ethics, research, and biosafety committees, Ministry of health)
- Stay up-to-date with changes in regulations or submission requirements
- Coordinate with study and site related processes (e.g., handling regulatory queries)
Requirements:
- Bachelor's degree or equivalent
- Broad experience in clinical trial applications of clinical trials to Cofepris
- Strong written and verbal communications skills in English and Spanish
- Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment
- Deep knowledge of Mexican regulations for clinical research
Salary Range: $80,000 - $120,000 per year
About GSK: We unite science, technology, and talent to get ahead of disease together. As a global biopharma company, we focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas: infectious diseases, HIV, respiratory/immunology, and oncology.
-
Global Clinical Trials Operations Coordinator
hace 3 semanas
Xico, México Worldwide Clinical Trials A tiempo completoAbout the RoleWe are seeking a skilled and detail-oriented Global Clinical Trials Operations Coordinator to join our team at Worldwide Clinical Trials. In this role, you will play a critical part in ensuring the smooth operation of our clinical trials.
-
Clinical Assessment Expert
hace 2 semanas
Xico, México Worldwide Clinical Trials A tiempo completoJob DescriptionWe are seeking a Clinical Assessment Expert to join our team at Worldwide Clinical Trials. This role is responsible for all aspects of assigned projects that include clinical assessment, training development, and data review.Key Responsibilities:Assist in the review of eCOA/ePRO specifications and engage in User Acceptance Testing of equipment...
-
Clinical Trial Associate II, TMF Operations Specialist
hace 1 semana
Xico, México Worldwide Clinical Trials A tiempo completoJob Title: Clinical Trial Associate II, TMF Operations SpecialistJob Summary:We are seeking a highly organized and detail-oriented Clinical Trial Associate II, TMF Operations Specialist to join our team at Worldwide Clinical Trials. In this role, you will be responsible for processing, maintaining, and archiving all essential documents in compliance with...
-
Accounts Receivable Expert
hace 2 semanas
Xico, México Worldwide Clinical Trials A tiempo completoJob DescriptionWe are seeking a highly skilled Associate, Accounts Receivable to join our team at Worldwide Clinical Trials.Job Summary:Prepare and render invoices to sponsors/clients for services, pass-through cost reimbursements, and grants.Maintain and reconcile billing, accounts receivable, and related reports.Reconcile unbilled services/reimbursable...
-
Regulatory Intelligence Expert
hace 4 semanas
Xico, México Syneos - Clinical And Corporate - Prod A tiempo completo**Job Summary**The Regulatory Intelligence Department at Syneos Health plays a crucial role in shaping decision-making at the highest levels. The team analyzes and refines Syneos Health regulatory intelligence from internal and external sources, combining knowledge from therapy areas and functions to deliver proactive advice outlining risks and new...
-
Clinical Trial Specialist
hace 2 semanas
Xico, México Thermo Fisher Scientific A tiempo completoJob Summary:We are seeking a Clinical Trial Specialist with expertise in regulatory compliance to join our team at Thermo Fisher Scientific. As a Clinical Trial Specialist, you will be responsible for ensuring the seamless execution of clinical trials while adhering to regulatory requirements and company standards.
-
Global Clinical Expert
hace 2 semanas
Xico, México Lilly A tiempo completoAt Lilly, we strive to unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, our employees work diligently to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Senior Legal Regulatory Advisor
hace 4 semanas
Xico, México Syneos - Clinical And Corporate - Prod A tiempo completoJob OverviewWe are seeking a highly skilled Senior Legal Regulatory Advisor to join our team at Syneos Health.About UsSyneos Health is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success. Our unique clinical, medical affairs, and commercial insights drive outcomes to address modern market realities.Our...
-
Clinical Research Coordinator
hace 4 semanas
Xico, México Clinical Trial Network A tiempo completoWe are seeking a highly skilled Clinical Research Coordinator to join our team at Clinical Trial Network in Houston, Texas.This full-time position offers an exciting opportunity for a motivated individual to work in clinical research and contribute to the planning, implementation, and coordination of studies.Responsibilities:Coordinate and manage all aspects...
-
Clinical Trials Senior Lead
hace 4 semanas
Xico, México Novo Nordisk A tiempo completoWe are seeking a highly skilled Clinical Trials Senior Lead to join our team at Novo Nordisk. As a key member of our Clinical Development department, you will be responsible for ensuring compliance with importation and exportation laws, maintaining close communication with CDC TMs, and anticipating potential risks to avoid them.Key Responsibilities:Be the...
-
Clinical Trials Specialist
hace 4 semanas
Xico, México Icon Plc A tiempo completoContract Analyst I Job DescriptionAt Icon PlcWe are seeking a skilled Contract Analyst I to play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.Key Responsibilities:Review and analyze contracts, agreements, and legal documents related to...
-
Operations Coordinator for Clinical Trials
hace 3 semanas
Xico, México Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, we are seeking a highly skilled Operations Coordinator to support our clinical trials team. This role is ideal for an individual who is detail-oriented, organized, and able to work effectively in a fast-paced environment.**Job Summary:**The Operations Coordinator will be responsible for coordinating and overseeing various tasks...
-
Senior Regulatory Counsel
hace 3 semanas
Xico, México Syneos - Clinical And Corporate - Prod A tiempo completoSyneos Health is a leading biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.Our company culture is based on teamwork, with every role vital to furthering our vision of Shortening the Distance from Lab to Life....
-
Global Clinical Development Medical Expert
hace 2 semanas
Xico, México Novartis A tiempo completoEstimate salary: $120,000 - $180,000 per year.About the RoleWe are seeking a highly skilled Clinical Research Medical Advisor to join our team in Mexico. This role will provide strategic and tactical leadership in clinical development plans that change the world.Key Responsibilities:Collaborate with Clinical Operations and Medical Affairs teams to ensure...
-
Clinical Trials Senior Analyst
hace 2 días
Xico, México Novo Nordisk A tiempo completoAbout the RoleWe are seeking a Clinical Trials Senior Analyst to join our team in Mexico. As a key member of our clinical development department, you will be responsible for ensuring compliance with importation and exportation laws.The successful candidate will have at least 3 years of experience as a Clinical Trials Assistant, preferably working with...
-
Clinical Feasibility Expert
hace 4 semanas
Xico, México Amgen A tiempo completoAbout AmgenWe are a global biotechnology company serving patients with innovative solutions. Our mission drives us to deliver high-quality products that make a meaningful difference in people's lives.Role OverviewThe Clinical Feasibility Expert will play a key role in supporting the development of clinical trials across various countries. This individual...
-
Global Payments Coordinator
hace 2 semanas
Xico, México Worldwide Clinical Trials A tiempo completoAbout the RoleWe are seeking a skilled Clinical Payments Specialist to join our team at Worldwide Clinical Trials. As a Clinical Payments Specialist, you will be responsible for the end-to-end management of global Investigator payments for assigned studies.Key ResponsibilitiesManage the set-up, deployment, and close-out of study payments solutionsPerform...
-
Global Clinical Trials Coordinator Specialist
hace 2 semanas
Xico, México Thermo Fisher Scientific A tiempo completoJob SummaryWe are seeking a skilled and detail-oriented Global Clinical Trials Coordinator to join our team. As a key member of our clinical operations group, you will play a critical role in supporting the coordination and execution of clinical trials.About the RoleThis position is responsible for providing administrative and technical support to project...
-
Clinical Quality Assurance Manager
hace 3 semanas
Xico, México Icon Plc A tiempo completoJob SummaryWe are seeking a seasoned Clinical Quality Assurance Manager to join our team at Icon Plc, a world-leading healthcare intelligence and clinical research organization.About the Role:The successful candidate will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to...
-
Clinical Operations Expert
hace 4 semanas
Xico, México Novartis A tiempo completoJob DescriptionWe are seeking a highly skilled Clinical Operations Expert to join our team at Novartis in Mexico. This is a full-time, regular position with no shift work required.About the RoleThe successful candidate will contribute to all operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and...