Descrição

Johnson & Johnson Consumer Health is recruiting for a R&D Scientist – Clinical Study, located in São José dos Campos, Brazil.This position will be responsible for clinical operations study activities for Consumer health products, focused mainly on OTC and Oral care products, but can include clinical activities to support personal care products as well. Operations activities includes study management and monitoring under GCP compliance, and this person will lead the development, planning, startup, conduct, and closure of clinical studies as well as site/CRO qualification and management.Key Responsibilities: Independently plan, initiate and manage operational aspects of assigned global clinical trials in accordance with Johnson & Johnson standards and international regulations (GCP/ICH), including planning, sponsor oversight, contracts, budgets and timelines, leading key relationships and acting as liaison with internal partners, external service providers, CROs and selected partners and ensure subject safety and data quality. Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments. Responsible for executing activities within site initiation and start-up, site/study monitoring, site management and site/study close-out per internal SOPs. Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Certify that related study documents are prepared reviewed and approved, including monitoring visit reports. Provides appropriate oversight of sites, CROs and/or suppliers. Serve as the primary point of contact with Investigators and J&J Study Team. Ensure set-up and maintenance of Trial Master Files. Handle study timelines and quotation, including key achievements. Identifies and calls out study-related issues and deviations to study team and senior management. Participates in the generation of corrective and preventative action plans. Writes Clinical Study Reports (CSRs), if needed. Ensures review and approval of CSRs. Ensures that all Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs) and Special Situations (SSs) are reported within reporting timelines and documented appropriately. Assures study is designed adequately to meet desired endpoints and/or substantiate aligned claim and is aligned with R&D strategy. Will lead and/or contributes to process improvement and training, as needed May lead and/or participates in special initiatives as assigned Will assume additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.This is not an extensive, comprehensive listing of job functions. May perform other duties as assigned.QualificaçõesEducation: Bachelor degree in Pharmacy, Biomedical Science or another relevant science field.Experience and Skills:Required: Proven experience in Clinical trial activities is required. Intermediate English is required (spoken and written).Preferred: Clinical trial monitoring experience is desirable. Advanced English is preferred (spoken and written). Experience on clinical trials for OTC products, Bioequivalence studies, is desirable Knowledge in Statistics is desirable. Interpersonal skills, ability to lead, negotiate and effectively represent a technical department on multi-functional global project teams. Flexible attitude and ability to work with global study teams in an agile environment.Other:We are looking for a person with outstanding interpersonal communication skills, a teammate with a strong problem-solving ability and a positive can-do attitude. The person needs to have strong organizational skills with shown success and the ability to efficient lead multiple challenging priorities in a global environment.Local PrincipalBrasil-São Paulo-São José dos Campos-Rod.Presidente Dutra, Km 154Outros LocaisBrasil-São Paulo-São José dos CamposOrganizaçãoJ&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda. (7600)CargoP&DRequisition ID1194200915

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