Empresa: J&J Brazil
Descrição da vaga: DescriptionSenior Scientist – R&D Clinical StrategyWho We AreAt 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. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of 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.What You Will Do?The Clinical Strategy team is responsible for leading the clinical sciences 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, in vitro data, additional new clinical studies and/or biowaiver, according to Regulatory framework defined for the project. The Clinical Strategy Sr 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 in LATAM markets from R&D Clinical Strategy standpoint focused on Mexico and Brazil as main countries
- Lead the development of clinical strategies for Self-Care (OTC) products submission to Health Authorities in collaboration with cross-functional team (mainly Product development, Regulatory Affairs/CMC, Analytical, Medical Affairs, Clinical Pharmacology and 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 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
This is not an extensive, comprehensive listing of job functions. May handle other activities as assigned.What we are looking forEducationA 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). Master/PhD degrees is desired.Experienced skillsRequired:
- At least 5 years of experience in the pharmaceutical industry in R&D working with Self Care within Clinical related areas (Strategy, Operations, Medical Affairs) and/or working on CROs specifically with Self Care (OTC) 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.
What’s in it for you
- Competitive Benefit Package
- Paid Company Holidays, Paid Vacation, Volunteer Time & More!
- Learning & Development Opportunities
- Employee Resource Groups
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.Primary Location Latin America-Brazil-São Paulo-São José dos Campos.
Localização: São José dos Campos – SP
