\n \n\nPosition Summary: \n\nThe Regulatory and Start Up Specialist (RSS) is an experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and provide support to the Site Contract Management group in budget and contract negotiation. The RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities and may contribute to development or revision of country specific tools and guidance documents to ensure compliance with local and international clinical trials regulations and guidelines. \n\nThis is a remote position and employee must reside in Canada.\n\nEssential functions of the job include but are not limited to: \n\n\nResponsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. \n\nPreparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, 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. \n\nInteraction with CA/EC for study purposes and handling responses to the CA/EC.  \n\nProviding 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 as relevant. \n\nMaintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.  \n\nPreparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. \n\nPartner with the assigned site CRA to ensure alignment in communication and secure site collaboration. \n\nPrepare. review and manage collection of essential documents required for site activation/IMP release. \n\nCustomize country/site specific Patient Information Sheet and Informed Consent Forms. \n\nResponsible for/facilitates the translation and co-ordination of translations for documents required for submission. \n\nMaintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. \n\nAct 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.  \n\nWhen required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. \n\nMay participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. \n\nKeep 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. \n\nMaintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF \n\nMay support the clinical team performing Pre-Study Site Visits.  \n\nMay support process improvement initiatives, training, and mentoring. \n\nPerforms other duties as assigned by management. \n\n\n\n\nQualifications: \n\nMinimum Required: \n\n\n* Fluent in English and French\n\nBachelor’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. \n\n1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies \n\n\n\n\nOther Required: \n\n\nStrong communication and organizational skills are essential. \n\nExperience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. \n\nFluency in English and for non-English speaking countries the local language of country where position based. \n\n\n\n\nPreferred: \n\n\nRelevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country. \n\nExperience using milestone tracking tools/systems. \n\nAbility to prioritize workload to meet deadlines. \n\nAdvanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science \n\n\n\n\nCompetencies \n\n\nKnowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. \n\nAbility to follow task-specific procedures, be attentive to detail and place importance on accuracy of information. \n\nStrong organizational skills. \n\nAbility to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located. \n\nAbility to work independently in a fast-paced environment with a sense of urgency to match the pace. \n\nMust demonstrate excellent computer skills. \n\nGood communication, presentation, interpersonal skills, both written and spoken, with an aptitude to learn how to inform, influence, convince, and persuade. \n\nFlexible attitude with respect to work assignments, and new learning. \n\nOccasional travel may be required. \n\n\n\n\n#LI-REMOTE\n\n  \n\n#Salary and compensation\n No salary data published by company so we estimated salary based on similar jobs related to Non Tech and Non Tech jobs that are similar:\n\n $30,000 — $50,000/year\n
\n\n#Benefits\n 💰 401(k)\n\n🌎 Distributed team\n\n⏰ Async\n\n🤓 Vision insurance\n\n🦷 Dental insurance\n\n🚑 Medical insurance\n\n🏖 Unlimited vacation\n\n🏖 Paid time off\n\n📆 4 day workweek\n\n💰 401k matching\n\n🏔 Company retreats\n\n🏬 Coworking budget\n\n📚 Learning budget\n\n💪 Free gym membership\n\n🧘 Mental wellness budget\n\n🖥 Home office budget\n\n🥧 Pay in crypto\n\n🥸 Pseudonymous\n\n💰 Profit sharing\n\n💰 Equity compensation\n\n⬜️ No whiteboard interview\n\n👀 No monitoring system\n\n🚫 No politics at work\n\n🎅 We hire old (and young)\n\n
\n\n#Location\nMontreal, Quebec, Canada