Scientist, Research & Development

Scientist, Research & Development

Что мы делаем

At Kenvue, мы осознаем необычайную силу повседневной заботы. Основанный на более чем вековом наследии и уходящий корнями в науку, мы являемся домом культовых брендов, включая NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® и BAND-AID®, которые вы уже знаете и любите. Наука – наша страсть; забота – это наш талант.

Кто мы

Наша глобальная команда – это ~ 22 000 блестящих людей с культурой рабочего места, где каждый голос имеет значение, а каждый вклад ценится. Мы увлечены идеями, инновации и стремление поставлять нашим клиентам лучшие продукты. Обладая опытом и эмпатией, быть Kenvuer означает иметь возможность влиять на миллионы людей каждый день. Мы ставим людей на первое место, заботимся о настолько, завоевываем доверие наукой и смело решаем – и вас ждут блестящие возможности! Присоединяйтесь к нам, чтобы формировать наше будущее и ваше. Для получения дополнительной информации, нажмите here.

Role reports to:

GER PESQ E DESENV

Местонахождение:

Latin America, Brazil, Sao Paulo, Sao Jose dos Campos

Место работы:

Гибрид

Что ты будешь делать

The Scientist, Research & Development is responsible for Clinical Operations activities, acting as Study Manager and/or Study Monitor for regional and/or global projects for Consumer Health products that may include Baby, Face, Body, Women’s Health, Oral Care, Sun Care or Self-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.

Key Responsibilities

• Operate 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 globally and train site personnel on study-specific protocol procedures and overall general Kenvue requirements
• Collaborate under the direction of Clinical Operations Study Management Leads globally who will provide study operational delivery strategy and guide on critical study elements
• Prepare 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
• 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
• 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

What We Are Looking For

Required Qualifications

• Minimum of a bachelor’s degree in science, Pharmacy, Chemistry, Biomedical Science, Engineering or related fields
• Experience as an independent Clinical Study Manager (or equivalent role) including, but not limited to, experience with protocol development, informed consent form, other essential clinical documents and electronic trial master file (TMF) management
• Advanced English is required (spoken and written)
• Flexible attitude and ability to work with global study teams and ESPs in an agile environment
• Excellent attention to detail
• Efficient, organized, and capable of prioritizing multiple tasks
• 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

• Experience as a Clinical Study Manager in global Clinical Studies

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 

“The hiring company may identify potential employee moves based on succession and/or development planning. All candidates need to apply through the formal bidding process”

Если вы являетесь человеком с ограниченными возможностями, пожалуйста, ознакомьтесь с нашим страница помощи инвалидам для получения информации о том, как запросить приспособление.