Clinical Protocol Writing Analyst

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October 31

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SYNVIA

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Transport • B2B

SYNVIA is a logistics and transport company specializing in secure, compliant, and customized supply chain solutions for high‑value and sensitive industries. The company provides multimodal transport (road, air, maritime), temperature‑controlled and regulated warehousing (including ICPE), handling of dangerous goods, customs transit services, and value‑added operations like co‑packing, labeling and kitting. SYNVIA focuses on B2B clients in sectors such as chemistry, energy, agriculture, cosmetics and public hygiene, emphasizing traceability, regulatory compliance, and operational agility.

51 - 200 employees

Founded 1993

🚗 Transport

🤝 B2B

📋 Description

• 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 project feasibility assessments; • Help identify potential risks and opportunities for projects in response to changes in legislation and/or applicable requirements; • Conduct literature reviews for the preparation of clinical study documents, regulatory-scientific opinions and Investigator Brochures; • Draft protocols and related documents for clinical studies; • Draft Investigator Brochures; • Update documents as needed following review by project stakeholders; • Prepare the complete project dossier for submission to the Sistema CEP/CONEP via Plataforma Brasil; • Prepare and submit amendments, notifications, interim reports, protocol deviations or responses to queries to the Sistema CEP/CONEP; • Respond to internal monitoring/audits performed by the Quality Assurance department; • Contribute to technical responses to requirements issued by competent authorities; • Archive research project documents in accordance with internal procedures; • Maintain the project database updated according to internal procedures; • Review Standard Operating Procedures (SOPs) relevant to the department and assist, if necessary, in managing the area's training matrix; • Attend Regulatory and Scientific Affairs meetings and other meetings when requested; • Participate in technical meetings with sponsors together with the Regulatory Affairs and Start-Up Management, when necessary; • Stay current with regulations and technical requirements applicable to the Brazilian regulatory agency and with international guidance for planning, conduct and submission of projects.

🎯 Requirements

• Bachelor's degree in Pharmacy-Biochemistry, Biomedicine, Biology, Biotechnology or related fields. • Experience writing clinical protocols for ANVISA submissions, including conducting systematic literature reviews to prepare clinical and non-clinical modules for drug registration dossiers. • Knowledge of CTD (Common Technical Document). • Strong writing skills. • Advanced English. • Basic Spanish. • Advanced Microsoft Office skills. • Training in Good Clinical Practice (GCP).

🏖️ Benefits

• Health plan with no monthly cost to the employee, with co-pay for tests and consultations; • Dental plan with co-pay; • Life insurance at no cost to the employee; • Flexible meal/food allowance (voucher); • Pharmacy discount program; • Synvia Partner Club (Educational Institutions, Language Schools, Leisure and Culture); • SESC partnership; • Physical health program - TotalPass; • Day Off – Health Professional; • Childcare assistance (per internal policy).