We're expanding our capabilities across mexico, brazil, argentina, colombia, chile, and peru, and we're hiring a senior regulatory and start up specialist (senior rss) in mexico!
as the senior rss on our team, you are a seasoned, experienced professional in regulatory and site start-up activities.
responsibilities will be dependent upon the location of the senior 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 providing support to the site contract management group in budget and contract negotiation.the senior rss may act as subject matter expert for questions by other in-country members (cras, csss or others) supporting site start-up activities, trainer for less-experienced staff on site start-up activities and may be identified as owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities and ensure compliance with local and international clinical trials regulations and guidelines.essential functionsresponsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any riskspreparation of clinical trial application forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to competent authorities (ca), ethics committee (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-gcpinteraction with ca/ec for study purposes and handling responses to the ca/ecproviding 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 relevantmaintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep regulatory leadership updatedpreparation/support the development of study specific start-up plans, imp release requirements and essential document review criteriapartner with the assigned site cra to ensure alignment in communication and secure site collaborationprepare, review and manage collection of essential documents required for site activation/imp releasecustomize country/site specific patient information sheet and informed consent forms.responsible for/facilitates the translation and co-ordination of translations for documents required for submissionmaintain 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 deliverablesact 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 countrywhen required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of site contract management department/designee departmentkeep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within precision for medicine to ensure the conduct of clinical trials according to international and local/national applicable regulationsmaintain audit/inspection readiness at all times and file documents as per tmf plan and/ or study specific plans in the relevant tmfmay support the clinical team performing pre-study site visitsmay participate/support feasibility group in site outreach to assess potential interest of investigators to a potential studymay support development of country specific country start-up summary and process flow identifying timelines, risks, and success factorsmay support development of training sessions to expand country start-up knowledge and act as subject matter expert for queriesmay mentor staff on local study start-up regulations, submissions, and internal proceduresmay interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as requiredperforms other duties as assigned by managementqualificationsminimum requiredbachelors' 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 experience3.5 years or more as a regulatory or su specialist in either a cro or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competenciesability to communicate both verbally and in writing at the english proficiently (professional level)other requiredexcellent communication and organizational skills are essentialexperience using computerized information systems, electronic spreadsheets, word processing and electronic mail requiredfluency in english and for non-english speaking countries the local language of country where position basedability to prioritize workload to meet deadlinespreferredrelevant regulatory and site start-up (feasibility, contract negotiations, ca/ec/irb submissions) experience for the particular countryexperience using milestone tracking tools/systemscan assist junior su specialists in problem resolutionadvanced degree in medical or life sciences (md, phd, pharmd)/rac certification/masters in regulatory sciencecompetenciesknowledge of good clinical practice/ich guidelines and other applicable regulatory requirementsability to follow task-specific procedures, be attentive to detail and place importance on accuracy of informationexcellent organizational skillsability to effectively interact with project team(s) and effectively communicate in english and the local language of the country where locatedability to work independently in a fast-paced environment with a sense of urgency to match the pacemust demonstrate excellent computer skillsexcellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuadeflexible attitude with respect to work assignments and new learningoccasional travel may be requiredprecision 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.
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