Agency Temporary

Position Summary The Contingent Worker- Regulatory Clinical Science Specialist will report to the Director, Regulatory Clinical Science and be responsible for contributing to the maintenance of global clinical regulatory compliance for investigational and marketed products and contribute towards the maintenance of study files in eCTD format. This position will support the organization in the management and conduct of clinical programs, focusing on accurately and efficiently filing appendices in clinical study reports and maintaining files to ensure ongoing compliance with regulatory requirements.Essential Functions Accurately and efficiently file documents for Appendix 16.1.4 and 16.1.5 of the clinical study report for all active clinical studiesEnsure that all documents are properly labeled, dated, and stored in accordance with company policies and regulatory requirementsHelp with filing documents for closing clinical studies, ensuring that all necessary appendices are accounted for and properly stored in accordance with ICH E3 guidanceMaintain accurate records of filed documents, including updating tracking systems and databases as neededCollaborate with team members to ensure that documents are filed and formatted correctly and that any issues are resolved promptlyCreate and maintain project plansCreate, edit and adhere to Standard Operating Procedures (SOPs).Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.Education & ExperienceBachelor’s degree in life sciences or a related field required; 3+ years of relevant regulatory clinical Science experience is required ; ORMaster’s degree in life sciences or a related field required; 2+ years of relevant regulatory clinical Science experience is requiredMid-level regulatory or clinical operation expertise preferredExperience in the preparation of the submission of clinical modules in eCTD format is preferredFamiliar with organizing responses to Health Authority information requests is preferredFamiliarization with regulatory submissions internationally is preferred.Knowledge, Skills, & AbilitiesKnowledge of Health Authority clinical guidance documents and requirementsKnowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelinesStrong Attention to detailStrong knowledge of clinical documentation and terminologyAbility to work with firm deadlines and adapt quickly to changing requirements and prioritiesStrong organizational skills, written and oral communication skills, and attention to detailWorking Environment / Physical EnvironmentThis is a full-time position (40 hours per week) on-site.Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.This desk-based role involves close study of scientific and regulatory documents.They will work closely with scientific colleagues throughout the day, often on a project-team basis.Lift and carry materials weighing up to 20 pounds.The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.$40.00 (entry-level qualifications) to $45.00 (highly experienced) per hourThe application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.This is the pay range the Company reasonably expects to pay for this position at the time of this posting. Compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position.