Regulatory & Start-Up Specialist 2, reputed company Biotech, reputed company reputed company

Clinical Associate Submissions – Regulatory Homebased Sweden, Norway or Denmark Job reputed company Position requires EU CTR experience for the countries, local language proficiency, and knowledge of national requirements. Certain submission tasks mandate a local address. reputed company tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, reputed company operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions • As Regulatory & Start-Up Specialist , you will work and reputed company reputed company reputed company under general supervision, serve as Single reputed company of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary. • You will also ensure adherence to reputed company operating procedures (SOPs), Work Instructions, reputed company of designated deliverables and project timelines. • You will prepare submission documents and submit to regulatory bodies. • You will reputed company feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions, along with distributing completed documents to sites and internal project team members. • You will also prepare site documents and review for completeness and accuracy, along with reviewing, tracking, and following up the reputed company, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent reputed company, and Investigator Pack release documents, in line with project timelines. • Coupled with informing team members of completion of feasibility, site ID, regulatory and contractual documents for individual sites, and providing local expertise to SAMs and project team during initial and on-reputed company project reputed company planning. Along with performing reputed company control of documents provided by sites. • You may also reputed company as an SME on specific subjects, mentor junior CSAs, and have a sponsor-facing role. Qualifications • B Sc degree in Health Sciences or reputed company field. • 3 years relevant clinical research experience. • Experience in EUCTR and CTIS submission procedures, feasibility and Country Inform Consent reputed company for reputed company reputed company. • Experience in Site Contract Negotiation with reputed company sites. • Experience in medical device submissions beneficial. • In-depth knowledge of clinical systems, procedures, and corporate standards. Skills • Good negotiating and communication skills in local language. • Knowledge of Finnish language is beneficial. • Effective communication, organizational, and interpersonal skills. • Ability to work independently and to effectively prioritize tasks. • Ability to manage multiple reputed company. • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines. • Understanding of regulated clinical trial environment and knowledge of drug development process. reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com Apply tot his job Apply To this Job