Country Approval Associate (client onsite), Poland-127824
Nr ref.: /JOBS.pl
PPD is a leading global contract research organization providing drug discovery, development, lifecycle management, laboratory services and outsourcing solutions.
With offices in 46 countries and more than 14000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe, effective therapeutics to patients and maximize returns on their R&D investments.
PPD has an exciting opportunity for a Country Approval Associate - Start-up Associate to join us onsite exclusively for one of our strategic pharmaceutical partners in Poland. PPD works in collaboration with this partner; you will be dedicated to the client projects and sites, working within their teams, systems and processes on behalf of PPD.
Country Approval Associate (client onsite) / Clinical Submission and Regulatory Specialist /
The Country Approval Associate will be responsible for obtaining Ethics and Regulatory approvals to conduct clinical studies in Poland and to ensure the activation of the sites in clinical studies. QualificationsMain duties and Responsibilities include but are not limited to:
•Prepare, review and coordinate local ethics and regulatory submissions in alignment with global submission strategy; •Act as a key contact for the study team, on a country level, for the start-up related activities and provide oversight for projects; •Prepare and collect the documentation required for site's initiation in a clinical study, in collaboration with the Clinical Research Associate; •Provide local regulatory strategy and advice for the conduct of clinical trials; Ideally candidates will have regulatory and submission experience or CRA experience in clinical studies and good knowledge of all applicable national regulatory requirements. If you have excellent English skills and ability to work in a team environment and independently with minimum supervision then apply now!
In return we will offer you a positive and supportive working environment within one of the most engaged teams in the industry; who are truly recognised as the cornerstone of our success. We will provide you with meaningful work and the opportunity to acquire valuable personal and professional skills.
HOW TO APPLY: Please submit your CV in English. Suitable candidates will be contacted accordingly.