Regulatory and Start Up Specialist (Portuguese speaker)

<p><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. </p>
<p>Due to our continued growth we are seeking a <strong>Regulatory and Start Up Specialist based in Spain</strong> to join our growing team. <strong>Apart from the experience with regulatory submissions, for this role it's key for candidates to have contracts and budgeting negotiation experience for Spain and be fluent in Portuguese language.</strong></p>
<p><strong>Essential functions of the job include but are not limited to:</strong></p>
<ul>
<li>Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.</li>
<li>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>Interaction with CA/EC for study purposes and handling responses to the CA/EC.</li>
<li>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>Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership</li>
<li>Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.</li>
<li>Partner with the assigned site CRA to ensure alignment in communication and secure site</li>
<li>Review and manage collection of essential documents required for site activation/IMP release.</li>
<li>Customize country/site specific Patient Information Sheet and Informed Consent Form.</li>
<li>Responsible for/facilitates the translation and co-ordination of translations for documents.</li>
<li>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>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>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>May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.</li>
<li>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>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>May support the clinical team performing Pre-Study Site Visits.</li>
</ul>
<p><strong>The ideal candidate will have:</strong></p>
<p><strong>Minimum Required:</strong></p>
<ul>
<li>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>A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.</li>
<li>Demonstrated experience in contracts and budgeting negotiation experience, on top of experience related to regulatory submissions.</li>
<li>Fluency in English and Portuguese</li>
</ul>
<p><strong>Other Required:</strong></p>
<ul>
<li>Previous experience working as a Regulatory or Start Up specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.</li>
<li>Strong communication and organizational skills.</li>
<li>Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.</li>
</ul>
<p><strong>Preferred:</strong></p>
<ul>
<li>Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience.</li>
<li>Experience using milestone tracking tools/systems.</li>
<li>Ability to prioritize workload to meet deadlines</li>
<li>Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.</li>
</ul>
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