Job Information
J&J Family of Companies Sr. Scientist in Sao Jose dos Campos, Brazil
Sr. Scientist - 2407016813W
Description
Kenvue is currently recruiting for:
Sr. Scientist
The Senior Scientist, Clinical Operations is responsible for leading the study management operational aspects for clinical studies for regional and/or global projects for Consumer Health products that may include Baby, Face, Body, or Sun Care in support of product development and claims substantiation.
Clinical Operations activities include (but are not limited to) clinical study management under GCP compliance, development, planning, startup, conduct, and closure of clinical studies as well as site/CRO qualification and management.
This position is based at LATAM.
Who We Are
At Kenvue (https://kenvue.taleo.net/enterprise/kenvue.com/careers) , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours. For more information, click here (https://www.youtube.com/watch?v=XhsbOsBiX_M) .
What You Will Do
The SR. Scientist is responsible for:
Key Responsibilities
Lead all operational aspects of assigned clinical studies in accordance with ICH GCP guidelines, company standard operating procedures, and local regulations.
Ensure that all clinical trials are conducted in compliance with the study protocol and all contractual agreements to ensure subject safety, data quality and accurate study timelines, budgets and quality standards are met.
Participate in and coordinate the selection/evaluation/setup of external service providers (ESPs) (e.g., study sites, investigators, etc.) including execution of quality/security assessments, confidentiality agreements, healthcare compliance submissions, clinical trial agreements, and purchase orders, in cooperation with Healthcare Compliance, Quality & Compliance, Information Security Risk Management, and Contracting teams.
Serve as the primary point of contact with selected ESPs and train site personnel on study-specific protocol procedures and overall general Kenvue requirements.
Prepare and/or review/approve study-specific essential documents including informed consent forms (ICFs), training materials, source documents, case report forms (CRFs), statistical analysis plans, recruiting materials, etc. As needed, coordinate the translation of study-specific documents and the procurement of appropriate license agreements.
Oversee preparation and clinical release of investigational and auxiliary products, including determining required quantities, approving clinical label copies, overseeing development of reference safety materials, and ensuring accountability and final disposition of the products.
Ensure Sponsor oversight by monitoring the progress of studies and the performance of ESPs on a continual basis through review/preparation of monitoring plans/reports, ongoing communication with the ESPs, review of clinical listings and logs, and routing/resolution of queries.
Identifies and raises study-related issues and deviations to study team and senior management. Participates in the generation of corrective and preventative action plans
Ensure that all Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs), and Pregnancies are reported within required reporting timelines and documented/processed appropriately.
Set-up and maintain the Trial Master File (TMF) in real time following internal procedures.
Coordinate and lead clinical trial disclosures on public registries, as needed.
Track invoices against key deliverables and review/approve invoices from vendors to ensure timely payment and compliance with contracts and study budgets.
Contribute to the writing and review of Clinical Study Reports, ensuring they are written and approved within required timelines.
Assist more senior Study Managers with above and/or additional tasks as needed for higher complexity studies.
Qualifications
What We Are Looking For
Required Qualifications
Minimum of a bachelor’s degree in science, nursing, or related field.
Minimum 3 years of experience as an independent Sponsor Clinical Study Manager or (or equivalent role) including, but not limited to, experience with protocol development, informed consent form, and other essential documents.
Advanced English is required (spoken and written).
Excellent written and verbal communication and presentation skills, in English.
Flexible attitude and ability to work with global study teams in an agile environment
Excellent attention to detail.
Good problem-solving and critical thinking skills.
Efficient, organized, and capable of prioritizing multiple tasks.
Proficiency in ICH GCP regulations/guidelines.
Proficiency in Microsoft applications including Outlook, Word, Excel, Teams, PowerPoint, and Adobe.
Good interpersonal relationship skills and being able to work effectively in cross-functional teams both internally and externally to the organization.
Willingness to adapt to changing priorities and assignments.
Willingness to travel up to 10% of time.
Desired Qualifications
CCRP or equivalent certification.
Demonstrated working knowledge of cosmetic and drug regulations.
Experience with TMF Reference Model.
What’s In It For You
Competitive Benefit Package
Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
Learning & Development Opportunities
Employee Resource Groups
This list could vary based on location/region
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location Latin America-Brazil-São Paulo-São José dos Campos
Job Function R&D
Req ID: 2407016813W