Cientista Pesquisa e Desenvolvimento São José dos

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Johnson & Johnson Consumer Health is recruiting for a **Cientista Pesquisa e Desenvolvimento** to work in **São José dos Campos com prazo determinado** de 1 ano.**

This position will be responsible for Clinical Operation activities, acting as Study Manager and/or Study Monitor for management of Clinical Safety and Efficacy studies for local, regional and/or global projects for Consumer Health products (Body, Sun, Face, Baby, Engineered products, etc.).

This position will be responsible for operational aspects of site management activities and monitoring for the assigned studies based on ICH guidelines, SOP requirements, protocol and regulatory requirements. Activities include the development, planning, startup, conduct, and closure of clinical studies and report finalization as needed in accordance with all applicable ICH/GCP guidelines and Company’s policies.

**RESPONSIBILITIES**:

- Work in partnership with Clinical strategy to design the study/methodology synopsis to substantiate safety and/or efficacy claims aligned with R&D strategy;
- Act as study manager for Clinical studies, ensuring that all related study documents are prepared reviewed and approved, managing study timelines including key milestones;
- Execute activities within site initiation and start-up, site/study monitoring, site management and site/study close-out per internal SOPs, including maintenance of Trial Master Files;
- Provides appropriate oversight of sites, CROs and/or suppliers;
- Conduct site monitoring activities;
- Identifies and raises study-related issues and deviations to study team and senior management;
- Participates in the generation of corrective and preventative action plans;
- 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;
- For new site/CRO, perform qualification visit and write report. Identify gaps and follow up on action plans until resolved;
- Assist in all audits and inspections;
- 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 “Specialist”.

**Qualifications**
- **Bachelor degree in Health related field, Pharmacy, Chemistry, Biomedical Science, Engineering or related fields;**:

- **Required minimum of 1 year experience in clinical research or equivalent, preferably on cosmetic clinical studies;**:

- Knowledge of ICH GCP is required;
- Intermediate English is required (spoken and written);
**Preferred**:

- Advanced English is desirable (spoken and written);
- Experience in SPF in vivo studies execution is desirable;
- Flexible attitude and ability to work with global study teams in an agile environment.

**Primary Location**
Brazil-São Paulo-São José dos Campos-Rod.Presidente Dutra, Km 154

**Organization**
J&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda. (7600)

**Job Function**
R&D

**Requisition ID**
2206056292W