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Clinical Research Development Analyst

🕒 September 24

🇧🇷 Brazil – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🗣️🇧🇷🇵🇹 Portuguese Required

Where this job comes from

Posted on LIBBS FARMACÊUTICA LTDA's careers page, not through a job board

First seen by Remote Rocketship September 24

Still open on LIBBS FARMACÊUTICA LTDA's site. Checked 3 hours ago.

Logo of LIBBS FARMACÊUTICA LTDA

LIBBS FARMACÊUTICA LTDA

1001 - 5000 employees

Founded 1958

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

LIBBS FARMACÊUTICA LTDA is a Brazilian pharmaceutical company with a focus on producing biological medications and a commitment to innovation and research. Established for over 67 years, the company employs around 3,800 people and is recognized as one of the top laboratories in the pharmaceutical retail sector in Brazil. LIBBS specializes in various therapeutic areas, including cardiometabolic, dermatology, gastrointestinal, gynecological, hematological, oncological, respiratory, and central nervous system treatments, with over 100 product brands and a strong emphasis on improving patient health and well-being.

📋 Description

• Ensure the clinical development strategy is prepared within established timelines and budgets, assessing efficacy and safety for registration, registration renewal, or the generation of additional clinical data • Assist in preparing clinical study protocols for Phases I, II, III, and IV • Execute protocol clinical development, incorporating decision points and criteria with the team and management • Collaborate with internal clients to prepare clinical development plans in accordance with regulatory requirements and Marketing and Sales needs • Prepare responses to regulatory authority requests concerning clinical data • Assist in preparing the final clinical study report, with support from clinical monitoring, ethics, statistics, and medical consulting teams • Assist in preparing the clinical registration dossier 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 colleagues, CROs, research centers, and other partners • Assist with due diligence processes and the evaluation of potential partners • Outline 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 education, specialization, and/or a master's degree related to Clinical Research is a plus

🏖️ Benefits

• Meal voucher • Food allowance • 100% coverage of Libbs medications • Pharmacy benefit through Vidalink • Profit-Sharing and Results Program (PPR) • Parking, transportation allowance, or company shuttle • USE Program: subsidy toward purchasing the equipment used for work, which may also be used for personal purposes • Flexible benefits, including TotalPass, life insurance, private pension plan, medical and dental insurance, and meal allowance • Flexible working hours, with start times between 7:00 a.m. and 9:00 a.m. and end times between 4:00 p.m. and 6:00 p.m. • Remote work • Access to coworking spaces worldwide

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