Specialist Scientist – R&D Clinical Science Self Care

Specialist Scientist – R&D Clinical Science Self Care

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 Clinical Science team is responsible for leading the clinical strategy development behind our innovation projects that support the safety and efficacy of our scientific communications and claims, translating the science behind our products for consumers and healthcare professionals.

You will lead de development of the clinical strategy for Latam Self Care (OTC drugs) projects with Brazil and Mexico as main countries. This includes defining strategies to support product safety and efficacy through a range of sources, including clinical previous data, scientific literature, analytical data, additional new clinical studies and/or biowaiver, according to Regulatory framework defined for the project. The Clinical Science Principal Scientist will also be responsible for executing the clinical strategy defined, which includes leading clinical data collection for product regulatory dossier in CTD (Common Technical Document) format.

Key Responsibilities:

• Act as Subject Matter Expert (SME) for a pool of new products development/ introduction and product maintenance (OTC drugs) in LATAM markets from R&D Clinical Science standpoint focused on Mexico and Brazil as main countries

• Lead the development of clinical strategies for Self-Care (OTC drugs) products submission to Health Authorities in collaboration with cross-functional team (mainly Product development, Regulatory Affairs/CMC, Analytical, Medical Affairs, Clinical Pharmacology and Clinical Operations)

• Execute clinical plan in alignment with business strategy, budget available and timeline to meet desired regulatory milestones

• Write technical documents to support product registration according to quality and compliance policies and regulatory requirements and support appropriate answer to deficiency letters from Health Authorities on the dossiers submitted

• Lead the consolidation of clinical documents for dossier submission on CTD format

• Work in collaboration with a multifunctional team to define the best comparator products for comparative pharmacokinetic studies; Clinical Operations team for the appropriate study protocol development and overall management of execution of clinical studies to support regulatory submission

• Communicate clearly with regional and global teams in forums related to projects from strategy definition to project execution

• Collaborate effectively with project members following priorities, checkpoints and timelines to guarantee project milestones

• Communicate effectively to leadership on issues which require escalation

What we are looking for

Required Qualifications

• A minimum of a bachelor’s degree in health-related sciences: Pharmacy/Pharmacy Biochemistry, Biomedical Sciences and/or other area with experience in Clinical strategy/studies for Self-Care (OTC drugs). Master/PhD degree is highly desired and a differential.

• Solid experience in the pharmaceutical industry in R&D working with Self Care within Clinical related areas (Clinical Strategy/Science, Clinical Operations, Medical Affairs) and/or working on CROs specifically with Self Care (OTC drugs) studies

• Solid experience in OTC product registration process, from clinical strategy definition to health authority submission to Anvisa and ideally to Cofepris.  

• Advanced English (speaking, writing, listening, and reading): ability to independently conduct meetings with global peers, adequate communication in writing (emails, documents, publications)

• Knowledge of ANVISA main regulations related to clinical (i.e. RDCs Nº 9/2015, 742/2022, 749/2022, 753/2022 and respective guidelines 59, 60, 61, 64; RE 894/2003, 895/2003).

• Experience with New Molecules Committee and Cofepris will be considered high differential

• It is preferred that this candidate have strong technical writing skills and project management skills

• A least basic level of Spanish can be considered a differential

• Ability to efficient lead multiple challenging priorities

Availability to work in São José dos Campos/SP at least 2x per week is desired

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