Regulatory and Start Up Specialist

October 18

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pfm medical, inc.

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Medical Device Manufacturing

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Description

•Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. •Preparation 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. •Interaction with CA/EC for study purposes and handling responses to the CA/EC. •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 •Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership •Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. •Partner with the assigned site CRA to ensure alignment in communication and secure site •review and manage collection of essential documents required for site activation/IMP release. •Customize country/site specific Patient Information Sheet and Informed Consent Form. •Responsible for/facilitates the translation and co-ordination of translations for documents. •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. •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. •When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. •May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. •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. •Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF •May support the clinical team performing Pre-Study Site Visits.

Requirements

•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. •1 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. •Experience in submissions to the Taiwan FDA •Experience in working on EC/IRB submissions in Taiwan •Strong communication and organizational skills. •Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. •Fluency in English. •Relevant regulatory and site start-up (feasibility, contract negotiations) experience. •Experience using milestone tracking tools/systems. •Ability to prioritize workload to meet deadlines •Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science.