Clinical Research Development Analyst
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Job Description
Clinical Research Development Analyst supporting clinical trial strategies, protocols, and regulatory dossiers. Contributing to new medicine approvals and clinical data generation at Libbs Farmacêutica.
Responsibilities:
- Ensure the development of clinical development strategies within established timelines and budgets, assessing efficacy and safety for registration, registration renewal, or clinical data generation
- Assist in preparing protocols for Phase I, II, III, and IV clinical studies
- Execute clinical development activities for protocols, incorporating decision points and criteria in collaboration with the team and management
- Collaborate with internal stakeholders to prepare clinical development plans aligned with regulatory requirements and Marketing and Commercial needs
- Prepare responses to regulatory authority requests related to clinical data
- Assist in preparing the final clinical study report with scientific quality
- Assist in preparing clinical registration dossiers and support regulatory, ethical, and health authority approval processes
- Review package insert text related to Clinical Research data
- Support high-level project planning and prepare Standard Operating Procedures (SOPs)
- Collaborate with the Clinical Research team, internal peers, CROs, research sites, and other partners
- Assist with due diligence processes and the evaluation of potential partners
- Develop clinical development proposals during the conceptual and economic feasibility assessment of projects
Requirements:
- Bachelor’s degree in a health-related field
- Advanced English proficiency
- Knowledge of Phase I, II, III, and IV clinical studies
- Postgraduate degree, specialization, and/or master’s degree related to Clinical Research is a plus
- This position is also open to people with disabilities
Benefits:
- Meal allowance
- Food allowance
- 100% coverage of Libbs medications
- Vidalink pharmacy benefit
- Profit-Sharing and Results Program (PPR)
- Parking, transportation allowance, or company shuttle
- USE Program: subsidy toward the purchase of equipment used for work, which may also be used for personal purposes
- Flexible benefits (TotalPass, life insurance, private pension plan, medical and dental insurance, and food allowance)
- Remote work
- Flexible working hours (start between 7:00 a.m. and 9:00 a.m.; finish between 4:00 p.m. and 6:00 p.m.)
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