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Specialist Scientist – R&D Clinical Science Self Care (Fixed term-12 months)

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2607043461W
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Kenvue is currently recruiting for a:

Specialist Scientist – R&D Clinical Science Self Care (Fixed term-12 months)

What we do

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.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.  We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact 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.

Role reports to:

DIR ASSOCIA PESQ E DESENV

Location:

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

Work Location:

Hybrid

What you will do

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).

  • 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).

  • 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

Desired Qualifications

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

  • Master/PhD degrees.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.