Medical Writing Analyst, Start‑up I

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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 grounding in applicable legislation; • Participate in discussions to define the best strategy for different projects; • Assist in the project feasibility assessment process; • Assist in identifying potential risks/opportunities for projects arising from changes in legislation and/or applicable requirements; • Conduct literature reviews to prepare clinical study documents, regulatory-scientific opinions and Investigator Brochures; • Draft clinical study protocols and related documents; • Prepare Investigator Brochures; • Revise documents as needed 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 issues to 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 research project documents in accordance with internal procedures; • Maintain the project database up to date according to internal procedures; • Review Standard Operating Procedures (SOPs) relevant to the department and assist, when necessary, in managing the department 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 team, when required; • Keep up to date with applicable regulations and technical requirements from the Brazilian regulatory agency and international guidance for planning, conducting and submitting projects.

🎯 Requirements

• Bachelor’s degree in Pharmacy-Biochemistry, Biomedical Sciences, Biology, Biotechnology or related fields; • Experience writing clinical study protocols for ANVISA submissions, including systematic literature review for drafting clinical and non-clinical modules for a drug registration dossier; • Knowledge of CTD (Common Technical Document); • Strong writing skills; • Advanced English; • Basic Spanish; • Advanced MS Office skills; • Training in Good Clinical Practice (GCP).

🏖️ Benefits

• Health plan with no monthly premium for the employee, with co‑payments for exams and consultations; • Dental plan with monthly co‑payment; • Life insurance at no cost to the employee; • Flexible meal/food allowance (voucher); • Pharmacy discount program; • Synvia Partnership Club (educational institutions, language schools, leisure and cultural offers); • SESC partnership; • Physical wellness program – TotalPass; • Day off for health professionals; • Childcare assistance (per internal policy).