(Senior) Specialist Regulatory Affairs/Start-Up | Wsl00
hace 1 día
.Company Description Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.Since its foundation in 1997, the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America, and Asia.Our company allows for employee visibility (you have a voice
), creative contribution, and realistic career development.We have nourished a true international culture here at Ergomed.We value employee experience, well-being, and mental health, and we acknowledge that a healthy work-life balance is a critical factor for employee satisfaction and, in turn, nurtures an environment from which high-quality client service can be achieved.Come and join us in this exciting journey to make a positive impact in patients' lives.Job Description The Specialist/Senior Specialist, Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables based on an established SSU RA management plan.
They also serve as a liaison between SSU/regulatory project team, authorities, vendors, and investigative sites in the planning, organizing, and executing SSU and regulatory deliverables following project, corporate, and industry regulatory strategies.DUTIES AND RESPONSIBILITIES: Support the SSU/Regulatory Lead to project site-specific submission/approval timelines and ensure they are met; if forecasted timelinesare not reached, provide clear rationale for delays and contingency plans to mitigate impact.
Anticipate and identify site issues during the start-up process and resolve minor to moderate issues independently.
Prepare, collect, review regulatory information and documents to support submissions to FDA, EMA, and national authorities (CTA/INDs, MAAs/NDAs/BLAs, ODDs, PIPs) as well as Ethic Committees/IRBs for initial authorisation and maintenance, in compliance with the applicable regulations.
Collect, review for completeness and compliance, and track essential documents to facilitate efficient site initiation and activation.
Investigate incomplete, inaccurate, or missing documents to ensure accuracy and completeness of information.
Prepare study team reports or updates regarding the status of essential document collection, review, and approval.
Actively correspond with selected sites for updates regarding essential document completion, Informed Consent Form (ICF) development, and regulatory/EC submissions/approvals.
Participate in ICF development, review, negotiation, and approval processes.
Coordinate with study teams, sponsors, clinical monitoring, clinical contracts, and/or other functional areas on the priority and processing of documents leading to investigational product release, site activation, and site initiation.
Support feasibility, site identification, and site documents customization (i.E., informed consent document) as needed and closely follow up with investigative sites for updates/resolution
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Madrid, España buscojobs España A tiempo completo(Senior) Specialist Regulatory Affairs/Start-Up | (FC628) Madrid EUR 50.000 - 70.000 Company Description: Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997, the company has grown organically and steadily by making strategic investments and landmark acquisitions, with...
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Madrid, España Ares Consultores A tiempo completoCompany Description: Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.Since its foundation in 1997, the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia.Our company allows for employee visibility (you...
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Madrid, España Ares Consultores A tiempo completoCompany Description: Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.Since its foundation in 1997, the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia.Our company allows for employee visibility (you...
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Madrid, España Ares Consultores A tiempo completoJob Description The Specialist/Senior Specialist, Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables based on an established SSU RA management plan.They also serve as a liaison between SSU/regulatory project team, authorities, vendors and investigative sites in the planning, organizing, and executing SSU...
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Madrid, España Ares Consultores A tiempo completoJob DescriptionThe Specialist/Senior Specialist, Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables based on an established SSU RA management plan.They also serve as a liaison between SSU/regulatory project team, authorities, vendors and investigative sites in the planning, organizing, and executing SSU and...
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Madrid, España Ares Consultores A tiempo completoJob DescriptionThe Specialist/Senior Specialist, Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables based on an established SSU RA management plan.They also serve as a liaison between SSU/regulatory project team, authorities, vendors and investigative sites in the planning, organizing, and executing SSU and...
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Madrid, España buscojobs España A tiempo completoJob Description The Specialist / Senior Specialist, Study Start Up and Regulatory is responsible for completing study start-up and regulatory deliverables based on an established SSU RA management plan. They also serve as a liaison between SSU / regulatory project team, authorities, vendors and investigative sites in the planning, organizing, and executing...
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Madrid, España Ares Consultores A tiempo completo.Company DescriptionErgomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.Since its foundation in 1997, the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America, and Asia.Our company allows for employee visibility (you...
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Madrid, España Ares Consultores A tiempo completo.Company DescriptionErgomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.Since its foundation in 1997, the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America, and Asia.Our company allows for employee visibility (you...
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Madrid, España Ares Consultores A tiempo completo.Company Description Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.Since its foundation in 1997, the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America, and Asia.Our company allows for employee visibility...
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Madrid, España Ares Consultores A tiempo completoCompany DescriptionErgomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.Since its foundation in 1997, the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America, and Asia.Our company allows for employee visibility (you...
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(Senior) Specialist Regulatory Affairs/Start-Up Gwv-777
hace 23 horas
Madrid, España Ares Consultores A tiempo completoCompany Description Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.Since its foundation in 1997, the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America, and Asia.Our company allows for employee visibility (you...
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(Senior) Specialist Regulatory Affairs/Start-Up Gwv-777
hace 22 horas
Madrid, España Ares Consultores A tiempo completoCompany DescriptionErgomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.Since its foundation in 1997, the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America, and Asia.Our company allows for employee visibility (you...
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