Clinical Research Analyst Pl (affirmative vacancy for Black and Brown professionals)

Come be part of Daiichi Sankyo, a Japanese pharmaceutical company whose mission is to contribute to improving the quality of life of people around the world through the creation and supply of innovative medicines that meet various medical needs. We have a culture of collaboration and trust and here, we want to develop and grow together. We are an inclusive company that embraces diversity. Everyone is welcome, regardless of sex, ethnicity, religion, sexual orientation, or any type of disability. Here, your talent speaks loudest! For more information on how your data will be treated, access the DSBR Privacy Policy.

Responsibilities and duties · Review clinical study documents (ICFs and other documents, as applicable).

• Monitor the status of ethical submissions conducted by CROs to Ethics Committees (CEP/CONEP), ensuring compliance with the scheduled deadlines.

• Provide local information and documentation to support responses to inquiries from Ethics Committees (CEP/CONEP).

• Review regulatory documentation prepared by CROs for submission to ANVISA (DDCM, DEEC, IMPD, DDP, Investigator's Brochure, DSUR, FAEC, protocol amendments, annual and final reports).

• Support the preparation and submission of technical responses, clarifications, and complementary documents requested by ANVISA, in conjunction with CROs.

• Provide support for regulatory and operational activities related to Compassionate Use Programs, Expanded Access, and Post-Treatment Access (PTA), as applicable.

• Fill out and support the preparation of feasibility forms for new products, contributing the Clinical Operations vision to other stakeholders.

• Identify possible regulatory and operational risks, communicating deviations and supporting the implementation of mitigation actions.

• Monitor, consolidate, and update performance indicators (KPIs) related to regulatory and study startup activities.

• Provide information on local regulatory and operational requirements for the implementation of central and local laboratories.

• Support activities related to contracts and budgeting of research centers when there is an impact on regulatory or study activation timelines.

• Contribute to the evaluation and selection of local suppliers, considering regulatory and operational feasibility aspects, when necessary.

• Support regulatory and operational activities related to Bioequivalence studies.

• Support the conduct of studies in Primary Care, including collaborative and investigator-initiated studies.

• Provide support for observational study activities (CTA, budget, payments).

• Maintain systems, tracking spreadsheets, and regulatory files updated, ensuring traceability and quality of documentation.

Requirements and qualifications · Completed higher education in Pharmacy, Biomedicine, Biology, or related health areas;

• Experience in Regulatory Affairs, preferably in Clinical Research, including preparation, review, and monitoring of regulatory submissions;

• Experience in Bioequivalence, collaborative/investigator-initiated studies, and new product feasibility will be a differentiator;

• Knowledge of clinical research regulations and ICH-GCP;

• Advanced English.

Additional information We offer the following benefits: VA/VR; Medical and Dental Assistance; Life Insurance; Totalpass; Pharmacy agreement; Private Pension; VT or parking space; PLR.