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Specialist Scientist – R&D Clinical Science Self Care

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Kenvue recrute actuellement pour un :

Specialist Scientist – R&D Clinical Science Self Care

Ce que nous faisons

Chez Kenvue, nous réalisons le pouvoir extraordinaire des soins quotidiens. S'appuyant sur plus d'un siècle d'héritage et enraciné dans la science, nous sommes la maison de marques emblématiques - dont NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® et BAND-AID® que vous connaissez et aimez déjà. La science est notre passion ; Le soin est notre talent.

Qui nous sommes

Notre équipe mondiale est composée de ~ 22 000 personnes brillantes avec une culture d'entreprise où chaque voix compte et chaque contribution est appréciée. Nous sommes passionnés par les idées, l'innovation et l'engagement à fournir les meilleurs produits à nos clients. Avec de l'expertise et de l'empathie, être un Kenvuer signifie avoir le pouvoir d'avoir un impact sur des millions de personnes chaque jour. Nous donnons la priorité aux personnes, nous nous soucions farouchement, nous gagnons la confiance grâce à la science et nous résolvons les problèmes avec courage - et nous vous offrons de brillantes opportunités ! Joignez-vous à nous pour façonner notre avenir et le vôtre. Pour plus d'informations, cliquez sur ici.

Role relève à :

GER PESQ E DESENV

Lieu :

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

Lieu de travail :

Hybride

Ce que tu vas faire

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

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