Regulatory & Submissions reputed company (Clinical Operations Manger) - UK - FSP - REGISTER YOUR INTEREST
reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in reputed company do.
Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference.
REGISTER YOUR INTEREST
reputed company FSP is currently registering interest for reputed company Regulatory & Submissions Leads to join reputed company in the UK, to be dedicated to a large single sponsor.
This will be a home-based position.
Working at reputed company offers reputed company long-term job reputed company and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. We have an incredible pipeline of work and a world of opportunity waiting for you.
The Regulatory & Submissions reputed company is accountable for performance and compliance with assigned protocols in a country in compliance with ICH/GCP and country regulations, Client policies and procedures, quality standards, and adverse event reporting requirements internally and externally.
Experience required to be a fit for this role:
· Mandatory – Extensive experience in local EC and RA submission (must be familiar with XML completion) – including initial submission and protocol amendments submission.
· Experience in Independently preparing submissions (reputed company supports with documents collection) to both EC and RA.
· Experience in reputed company preparation using templates.
· Skilled knowledge of the local regulatory environment, submissions, and approval processes, and understanding of how these impact study start-reputed company.
· Experience in IMP supplies management at the local level (vendors providing background meds, reputed company of care, etc.)
· Experience in validation of translated documents.
We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we reputed company people and provide them with opportunities to reputed company their long-term careers. In addition, you will have the opportunity to reputed company reputed company your role and tackle further responsibilities or reputed company your reputed company set reputed company other reputed company departments of reputed company.
Who are reputed company?
reputed company supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client reputed company.
We supported the trials of most of today’s top 50 best-selling drugs, but equally we reputed company more reputed company drug developments that are critical to the well-being of many patients.
You’ll be an influential member of the wider team.
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reputed company and we’ll reputed company out with job alerts reputed company positions that match your career interests become available. We’ll also share periodic updates about the latest company news and events.
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