Regulatory and Start Up Specialist - Fluent in Hungarian

About The Role

&lt;p&gt;&lt;span style=&quot;font-size: 10pt; font-family: arial, helvetica, sans-serif;&quot;&gt;Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering 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.&amp;nbsp;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;As our company continues we grow we are seeking a Regulatory and Start Up Specialist to join our growing team.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;strong&gt;Essential functions of the job include but are not limited to:&lt;/strong&gt;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.&lt;/span&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;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.&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Interaction with CA/EC for study purposes and handling responses to the CA/EC.&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;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&amp;nbsp;&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Partner with the assigned site CRA to ensure alignment in communication and secure site&amp;nbsp;&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;review and manage collection of essential documents required for site activation/IMP release.&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Customize country/site specific Patient Information Sheet and Informed Consent Form.&amp;nbsp;&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Responsible for/facilitates the translation and co-ordination of translations for documents.&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;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.&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;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.&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;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.&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;May support the clinical team performing Pre-Study Site Visits.&lt;/span&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;strong&gt;The ideal candidate will have:&lt;/strong&gt;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;strong&gt;Minimum Required:&lt;/strong&gt;&lt;/span&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;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.&amp;nbsp;&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Demonstrated experience as a Regulatory or Start Up specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Fluency in Hungarian language as this position will support Hungarian sites.&lt;/span&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;strong&gt;Other Required:&lt;/strong&gt;&lt;/span&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Strong communication and organizational skills.&amp;nbsp;&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Fluency in English.&amp;nbsp;&lt;/span&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;strong&gt;Preferred:&lt;/strong&gt;&lt;/span&gt;&lt;/p&gt;
&lt;ul&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience.&amp;nbsp;&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Experience using milestone tracking tools/systems.&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Ability to prioritize workload to meet deadlines&lt;/span&gt;&lt;/li&gt;
&lt;li style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.&lt;/span&gt;&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;&lt;span style=&quot;font-family: arial, helvetica, sans-serif; font-size: 10pt;&quot;&gt;#LI-OS1 #LI-Remote&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&amp;nbsp;&lt;/p&gt;&lt;div class=&quot;content-conclusion&quot;&gt;&lt;hr&gt;
&lt;p&gt;Any data provided as a part of this application will be stored in accordance with our&amp;nbsp;&lt;a href=&quot;https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&amp;amp;data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;amp;sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&amp;amp;reserved=0&quot;&gt;Privacy Policy.&lt;/a&gt;&amp;nbsp;For CA applicants, please also refer to our&amp;nbsp;&lt;a href=&quot;https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&amp;amp;data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;amp;sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&amp;amp;reserved=0&quot;&gt;