<div data-olk-copy-source="MailCompose"> <div> <p class="x_MsoNormal"><span data-olk-copy-source="MessageBody"><strong>Precision for Medicine</strong> is a global Clinical Research Organization with uniquely integrated offering which enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. </span></p> </div> <div> <p class="x_MsoNormal">Due to our continued growth we are seeking a <strong>Regulatory and Start Up Specialist</strong> based in <strong>Spain</strong> to join our growing team. Apart from the <strong>experience with regulatory submissions</strong>, for this role it's key for candidates to have <strong>contracts and budgeting negotiation experience</strong><strong> for Spain.</strong></p> </div> <div> <p class="x_MsoNormal"><strong>Essential functions of the job include but are not limited to:</strong></p> </div> <div> <p class="x_MsoNormal">Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.</p> </div> <ul type="disc"> <li class="x_MsoNormal">Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.</li> <li class="x_MsoNormal">Interaction with CA/EC for study purposes and handling responses to the CA/EC.</li> <li class="x_MsoNormal">Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team </li> <li class="x_MsoNormal">Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership</li> <li class="x_MsoNormal">Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.</li> <li class="x_MsoNormal">Partner with the assigned site CRA to ensure alignment in communication and secure site </li> <li class="x_MsoNormal">Review and manage collection of essential documents required for site activation/IMP release.</li> <li class="x_MsoNormal">Customize country/site specific Patient Information Sheet and Informed Consent Form. </li> <li class="x_MsoNormal">Responsible for/facilitates the translation and co-ordination of translations for documents.</li> <li class="x_MsoNormal">Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables.</li> <li class="x_MsoNormal">Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.</li> <li class="x_MsoNormal">When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.</li> <li class="x_MsoNormal">May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.</li> <li class="x_MsoNormal">Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.</li> <li class="x_MsoNormal">Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF</li> <li class="x_MsoNormal">May support the clinical team performing Pre-Study Site Visits.</li> </ul> <div> <p class="x_MsoNormal"><strong>The ideal candidate will have:</strong></p> </div> <div> <p class="x_MsoNormal"><strong>Minimum Required:</strong></p> </div> <ul type="disc"> <li class="x_MsoNormal">Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. </li> <li class="x_MsoNormal">A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.</li> <li class="x_MsoNormal">Demonstrated experience in contracts and budgeting negotiation experience. </li> </ul> <div> <p class="x_MsoNormal"><strong>Other Required:</strong></p> </div> <ul type="disc"> <li class="x_MsoNormal">Previous experience working as a Regulatory or Start Up specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/