Cientista Pesquisa e Desenvolvimento I - Sao Paulo, Brasil - Kenvue

Kenvue

Empresa verificada

Sao Paulo, Brasil

há 3 semanas

Postado por:

Ana Silva

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Descrição

CIENTISTA PESQUISA E DESENVOLVIMENTO I W

Description

Kenvue is currently recruiting for R&D Scientist I (fixed term) - Clinical Research & Operations. This position reports into Isabelle Siqueira Rennó Carvalho and is based at São José dos Campos, Brazil.

Who We Are

At Kenvue, part of the Johnson & Johnson Family of Companies (Kenvue), we believe there is extraordinary power in everyday care.

Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S and BAND-AID —are category leaders trusted by millions of consumers who use our products to improve their daily lives.

Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers' hearts and homes.

Join us in shaping our future-and yours.

Watch us here:

What will you do

The R&D Scientist I (fixed term) - Clinical Research & Operations is 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 New Planned Consumer Health Company 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.

Responsibilities

Work in partnership with Clinical strategy to design the study/methodology synopsis to substantiate safety and/or efficacy claims and product scientific communication, 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 startup, site/study monitoring, site management and site/study closeout per internal SOPs, including maintenance of Trial Master Files
Provides appropriate oversight of sites, CROs and/or suppliers. For new site/CRO, may perform qualification visit and write report. Identify gaps and follow up on action plans until resolved.
Conduct site monitoring activities and assist in all audits and inspections
Identifies and raises studyrelated 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.
May lead and/or contribute to process improvement/training and participate in special initiatives as assigned (as "Champion" or "Specialist").

This is not an extensive listing of job functions. May handle other activities as assigned.

Qualifications:

Required 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)

Desired Qualifications/Skills

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
Organization and attention to details
Ability to work in a highly procedural environment and attention to compliance requirements
Ability to analyze and question processes is highly desirable

Primary Location Latin America-Brazil-São Paulo-São José dos Campos

Organization JNTL Consumer Health (Brazil) Ltda. Legal Entity

Job Function R&D