Sr. Scientist

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, 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.

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 requ...