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Senior Scientist – R&D Clinical Science Self Care

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Senior Scientist – R&D Clinical Science Self Care

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

DIR ASSOCIA PESQ E DESENV

Locatie:

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

Werklocatie:

Hybride

Wat je gaat doen

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 desired.

  • 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

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

  • Experience in Health Authority clinical dossier of at least 1 Self Care project for Anvisa and/or Cofepris

  • 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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