We are seeking a remarkable vice president of clinical affairs to join our amazing team at empregara in rio de janeiro, your career as a full time vice president of clinical affairs is a fantastic opportunity to develop competitive you are strong in project management, communication and have the right initiative for the job, then apply for the position of vice president of clinical affairs at empregara today!Descriptionkerecis ( is a biotechnology company that is pioneering the use of fish skin and fatty acids in the globally expanding cellular therapy and regenerative medicine market. The fatty-Acid-Rich products from the companys patented technologies protect the bodys own tissues and enable the body to regenerate tissues. With offices in the united states (arlington, virginia, and minneapolis, minnesota), iceland (reykjavik and isafjordur) and germany (cologne). The company is experiencing significant growth and is looking for the ideal candidate to lead its clinical affairs group, which will be located in its minneapolis functionsselect clinical consultants and clinical research organizations (cros) and manage their contractsrecruit, hire, train, manage and facilitate the career development of clinical staffprepare and track the companys clinical trials budget on an annual basisallocate resources and budgets to various department projects and oversee their progressparticipate in preparation of clinical operating plans and objectives in alignment with company and department strategiessupervise the implementation of clinical programs and track their progressoversee the planning of new clinical programs and the development of clinical protocolsreview and approve submissions of protocols and reports to the relevant regulatory authorities and institutional review boards (irbs) or ethics committees (ecs)interact with investigators and irbs on financial and compliance issuesoversee the proper collection, analysis and presentation of clinical datareview and approve final case report forms, edit checks and clinical study databasesoversee development and maintenance of department standard operating procedures (sops)develop and manage the process for clinical regulatory document preparation and submissions for clinical studies (ide submissions, irb/ec submissions, etc.)author, oversee and/or review clinical evaluation plans, clinical evaluation reports, post market clinical follow up plans and reports, sscps and any other clinical documentation required for continued ce compliance of department activities to the relevant regulations, department sops and corporate requirementsdevelop and manage the process for clinical regulatory document preparation and submissions for clinical studies (ide submissions, irb/ec submissions, etc.)other tasks and responsibilities as assignedanticipated travel: 10-20%requirementscompetenciesstrong knowledge of fda regulations and international conference harmonization (ich) and good clinical practices (gcps) guidelinesdemonstrated experience with european clinical study requirements and ce marking, eumdd / mdr, meddev 2.7.1 revision 4, iso 14155 and other relevant regulationregulatory/clinical document writingability to independently lead clinical researchhigh interpersonal skillsfluency in englishexcellent teamwork skillsstrategic thinkingpresentation skillsleadership skillseducation & experiencem.D. Or ph.D. In science or health-Related field8+ years of experience in the medical device required, with a portion of that being in a medical/clinical affairs role6+ years of experience in laboratory, preclinical and clinical research roles requiredleadership or people management experience is an assetthis job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time. Kerecis is an equal opportunity employer. Benefits of working as a vice president of clinical affairs in rio de janeiro, rj:? Career growth potential? Advancement opportunities? Competitive salary.
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