SYNVIA

Analyst

• Handle sponsor requests with the required level of detail and based on current legislation;
• Participate in discussions to define the best strategy for different projects;
• Assist in the project feasibility process;
• Help identify potential risks/opportunities for projects when legislation and/or applicable requirements change;
• Perform literature searches to prepare clinical study documents, regulatory-scientific opinions, systematic literature reviews, and Investigator Brochures;
• Draft clinical study protocols and related documents;
• Prepare Investigator Brochures;
• Conduct systematic literature reviews;
• Write and evaluate clinical and non-clinical modules (CTD format) of documentation for drug registration and post-registration;
• Adjust drafted documents, when necessary, after review by project stakeholders;
• Prepare the complete project dossier for submission to the Research Ethics Committees (CEP/CONEP) system via Plataforma Brasil;
• Prepare amendments, notifications, interim reports, protocol deviations, or responses to issues raised by the CEP/CONEP system;
• Respond to internal monitoring/audits conducted by the Quality Assurance department;
• Contribute to technical responses to requirements issued by competent authorities;
• Archive project documents in accordance with internal procedures;
• Keep the project database up to date according to internal procedures;
• Write and/or review Standard Operating Procedures (SOPs) relevant to the department and assist, if needed, in managing the area's training matrix;
• Support other analysts in the department;
• Attend Regulatory and Scientific Affairs team meetings and other meetings as requested;
• Participate in technical meetings with sponsors and regulatory authorities together with Regulatory and Scientific Affairs Management, when necessary;
• Stay current with regulations and technical requirements applicable to the Brazilian regulatory agency and international guidelines for planning, conducting, and submitting projects;
• Represent the company before professional associations and participate in specific technical groups when the topic has significant impact for the company and/or sponsors.

Junior Medical Writing Analyst, Start-up

Conversion Rate Optimizer

• Act as a technical reference on the project, supporting the planning and execution of monitoring strategies.
• Conduct monitoring of high-complexity sites, high-recruiting sites, or sites with a history of critical deviations.
• Perform in-depth site performance assessments and support the implementation of corrective and preventive actions.
• Collaborate with the Project Manager to define, review, and follow up on the monitoring plan.
• Review monitoring reports from less experienced CRAs, ensuring standardization and quality.
• Prepare sites for audits and regulatory inspections (ANVISA, FDA, EMA), providing technical guidance.
• Identify operational risks and propose mitigation strategies to ensure adherence to timelines, data quality, and participant safety.
• Lead technical training sessions, initiation visits, and internal training activities for new CRAs.
• Support complementary study activities, such as eTMF review, regulatory support, and alignment with the sponsor on operational deliverables.
• Maintain senior-level communication with internal and external stakeholders, representing the monitoring function when required.

Clinical Research Associate II/III - CRO

Research Analyst

• Handle sponsor requests with the required level of detail and grounded in current legislation;
• Participate in discussions to define the best strategy for different projects;
• Assist in project feasibility assessments;
• Assist in identifying potential risks and opportunities for projects resulting from changes in legislation and/or applicable requirements;
• Conduct literature reviews for the preparation of clinical study documents, regulatory-scientific opinions, and Investigator's Brochures;
• Draft clinical study protocols and related documents;
• Prepare Investigator's Brochures;
• Adapt prepared documents, when necessary, following review by project stakeholders;
• Prepare the complete project dossier for submission to the CEP/CONEP system via Plataforma Brasil;
• Prepare and submit amendments, notifications, interim reports, protocol deviations, or responses to outstanding queries to the CEP/CONEP system;
• Respond to internal monitoring/audits conducted by the Quality Assurance department;
• Contribute technical responses to requests issued by competent authorities;
• Archive research project documents in accordance with internal procedures;
• Keep the project database updated according to internal procedures;
• Review Standard Operating Procedures (SOPs) relevant to the department and, if necessary, assist in managing the area's training matrix;
• Participate in Regulatory and Scientific Affairs meetings and as requested;
• Participate in technical meetings with sponsors alongside the Regulatory Affairs and Start-Up Management team, when necessary;
• Stay up to date with regulations and technical requirements applicable to the Brazilian regulatory agency and international guidelines for planning, conducting, and submitting projects.

Clinical Research Analyst

Administration

• Make value adjustments and update payment methods, ensuring correct system configuration.
• Process payment transfers and settle boleto payments (bank slips).
• Receive, check, and validate Notas Fiscais (tax invoices).
• Provide support and clarify payment-related queries.
• Compile and consolidate amounts, ensuring the accuracy of information for control and audit purposes.
• Update closing reports in the system, ensuring consistency of financial information.
• Monitor spreadsheets daily, performing critical analysis of listed invoices to identify inconsistencies and discrepancies.

Sales Administration Assistant

Procurement

• Prepare demand forecasts for products, services, and equipment using statistical data, market and sales information, including sales orders, customer contracts, planned promotional activities, seasonality, and other factors;
• Prepare monthly reports containing performance indicators, purchasing volume data by product classification and supplier, and budget control;
• Identify opportunities for cost reduction by analyzing the supplier portfolio;
• Monitor and evaluate trends, technologies, and new product developments to support the development and qualification of new suppliers. Typically has at least one year of experience;
• Lead negotiations with suppliers, analyzing prices, lead times, and payment terms;
• Conduct RFIs and RFQs, research prices for required products, services, and equipment to identify the best cost-benefit for the company, and manage purchase contracts with suppliers to ensure deadlines are met and contractual clauses are respected.

Junior Medical Writing Analyst, Start-up

Clinical Research Associate II/III - CRO

Clinical Research Analyst

Sales Administration Assistant

Procurement Analyst, Mid-level