Senior Clinical Development Analyst – Focus on Clinical Strategy and Documentation

Jobtailor; Itapevi; Presencial; BRL 201 000 - 290 000; Tempo integral

Resumo da oferta

Jobtailor is seeking a Regulatory/Clinical Documentation Specialist to assist in preparing and reviewing CTD documentation for regulatory submissions across medicines, medical devices, and cosmetics in Brazil. You will collaborate with R&D, Medical Affairs, Regulatory Affairs on strategy and risk mitigation.

The role requires a Pharmacy/Biology/Biomedicine degree, English fluency, and knowledge of CTD and Phase I–III trials; Spanish is a plus; postgraduate training desirable.

Qualificações

• Bachelor's degree in Pharmacy, Biology, or Biomedicine.
• Postgraduate degree, Master’s, PhD, and/or postdoctoral training in Pharmacokinetics, Pharmacology, or Clinical Research is desirable.
• Experience in Clinical Development within the pharmaceutical industry.
• Knowledge of national and international regulations specific to the field.
• Basic knowledge of drug development.
• Basic knowledge of statistics applied to clinical research.
• Excellent scientific writing skills.
• Knowledge of the Common Technical Document (CTD) for the registration and post-approval activities of medicines.
• Knowledge of Phase I, II, and III clinical trial conduct.
• Advanced English proficiency (writing, reading, and participation in some meetings).
• Intermediate Spanish is considered a plus.

Responsabilidades

• Assist in preparing and/or reviewing nonclinical and clinical documentation for CTD registration dossiers.
• Contribute to the development and discussion of clinical/regulatory strategies with R&D, Medical Affairs, and Regulatory Affairs.
• Conduct technical feasibility assessments for pharmacokinetic, efficacy, and safety clinical studies.
• Evaluate nonclinical and clinical dossier documentation as part of Due Diligence processes.
• Prepare technical questions and presentations for Anvisa to clarify technical issues and/or mitigate risks in the planning and execution of studies.
• Contribute to the preparation of responses to regulatory requirements.

Conhecimentos

Clinical Development Experience

Regulatory Strategy Development

Scientific Writing Skills

Pharmacokinetics Knowledge

CTD Knowledge

Formação académica

Bachelor's degree in Pharmacy/Biology/Biomedicine

Postgraduate degree in Pharmacokinetics/Pharmacology/Clinical Research desirable

Descrição da oferta de emprego

• Assist in preparing and/or reviewing nonclinical and clinical documentation for CTD registration dossiers, including systematic reviews of the scientific literature when necessary, for regulatory submissions involving new, innovative, specific, and biological medicines, medical devices, and cosmetics
• Contribute to the development and discussion of clinical/regulatory strategies with R&D, Medical Affairs, and Regulatory Affairs
• Conduct technical feasibility assessments for pharmacokinetic, efficacy, and safety clinical studies
• Evaluate nonclinical and clinical dossier documentation as part of Due Diligence processes
• Prepare technical questions and presentations for Anvisa to clarify technical issues and/or mitigate risks in the planning and execution of studies
• Contribute to the preparation of responses to regulatory requirements

Requirements

• Bachelor’s degree in Pharmacy, Biology, or Biomedicine
• Postgraduate degree, Master’s, PhD, and/or postdoctoral training in Pharmacokinetics, Pharmacology, or Clinical Research is desirable
• Experience in Clinical Development within the pharmaceutical industry
• Knowledge of national and international regulations specific to the field
• Basic knowledge of drug development
• Basic knowledge of statistics applied to clinical research
• Excellent scientific writing skills
• Knowledge of the Common Technical Document (CTD) for the registration and post-approval activities of medicines
• Knowledge of Phase I, II, and III clinical trial conduct
• Advanced English proficiency (writing, reading, and participation in some meetings)
• Intermediate Spanish is considered a plus

Core Competencies

Demonstrates expertise in preparing and reviewing clinical and nonclinical documentation for regulatory submissions, with a strong focus on the Common Technical Document (CTD) and clinical trial conduct. Proficient in scientific writing and regulatory strategy development, with advanced English proficiency and knowledge of pharmacokinetics.

Highest-signal resume keywords

• Clinical Development Experience
• Common Technical Document (CTD) Knowledge
• Scientific Writing Skills
• Regulatory Strategy Development
• Pharmacokinetics Knowledge

Hard Skills

• Clinical Research
• Pharmacokinetics
• Pharmacology
• Statistics Applied to Clinical Research
• Phase I, II, and III Clinical Trials
• Regulatory Submissions
• Technical Feasibility Assessments
• Due Diligence Processes
• Technical Documentation Review
• Risk Mitigation Strategies

Soft Skills

• Communication Skills
• Collaboration Skills
• Problem-Solving Skills

Industry Keywords

• Pharmaceutical Industry
• Regulatory Requirements
• Innovative Medicines
• Medical Devices
• Cosmetics
• National and International Regulations