Regulatory and Start Up Specialist

<p><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif;">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.&nbsp;</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">As our company continues we grow we are seeking a Regulatory and Start Up Specialist to join our growing team.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong>Essential functions of the job include but are not limited to:</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks.</span></p> <ul> <li><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">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.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Interaction with CA/EC for study purposes and handling responses to the CA/EC.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">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&nbsp;</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Partner with the assigned site CRA to ensure alignment in communication and secure site&nbsp;</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">review and manage collection of essential documents required for site activation/IMP release.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Customize country/site specific Patient Information Sheet and Informed Consent Form.&nbsp;</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Responsible for/facilitates the translation and co-ordination of translations for documents.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">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.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">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.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">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.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">May support the clinical team performing Pre-Study Site Visits.</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong>The ideal candidate will have:</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong>Minimum Required:</strong></span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">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.&nbsp;</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">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.</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong>Other Required:</strong></span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Strong communication and organizational skills.&nbsp;</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Fluency in English.&nbsp;</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong>Preferred:</strong></span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience.&nbsp;</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Experience using milestone tracking tools/systems.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Ability to prioritize workload to meet deadlines</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.</span></li> </ul> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">#LI-OS1 #LI-Remote</span></p> <p>&nbsp;</p><div class="content-conclusion"><hr> <p>Any data provided as a part of this application will be stored in accordance with our&nbsp;<a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fprivacy-policy%2F&amp;data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=9DgboiHTFPrNYVhdKhyfdwVyNYwUvZbP%2FroLdWIIfxw%3D&amp;reserved=0">Privacy Policy.</a>&nbsp;For CA applicants, please also refer to our&nbsp;<a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.precisionmedicinegrp.com%2Fca-applicants-privacy-notice%2F&amp;data=05%7C01%7Czeta.larcon%40precisionmedicinegrp.com%7Cb58fe8b0c3ea4dd2e79d08db5bd09a25%7Cb71ff3f628164ca8a9b938f820f91ad1%7C0%7C0%7C638204723732367131%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&amp;sdata=tfAqqMZsG%2B11IchL45HFFVbfECCkYqQpNr0PQxrMFJU%3D&amp;reserved=0">CA Privacy Notice</a>.</p> <p>Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.</p> <p>If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at <a href="mailto:myHR@precisionmedicinegrp.com">myHR@precisionmedicinegrp.com</a>.</p> <p><span data-teams="true"><strong>Recruitment Fraud Warning: </strong>Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at <a id="menur2oq" class="fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn" href="mailto:myHR@precisionmedicinegrp.com" target="_blank">myHR@precisionmedicinegrp.com</a> so we can investigate and take appropriate action.</span></p> <p><span data-teams="true"><strong><span data-olk-copy-source="MessageBody">Candidates must be legally authorized to work in the country of employment without employer sponsorship.</span></strong></span></p></div>