Medical Writing Analyst – Start-Up

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SYNVIA

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1993

🚗 Transport

🤝 B2B

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.

📋 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/opportunities for projects arising from changes in legislation and/or applicable requirements; • Conduct literature searches to prepare clinical study documents, scientific-regulatory opinions, systematic literature reviews and Investigator Brochures; • Draft protocols and documents related to clinical studies; • Prepare Investigator Brochures; • Prepare systematic literature reviews; • Write and evaluate clinical and non-clinical modules (CTD format) of documentation for drug registration and post-registration; • Revise documents as needed after review by project stakeholders; • Prepare the complete project dossier for submission to the Ethics Committee System (CEP/CONEP) via Plataforma Brasil; • Prepare amendments, notifications, interim reports, protocol deviations or responses to queries issued by the CEP/CONEP system; • Respond to internal monitoring/audits conducted by the Quality Assurance department; • Contribute to technical responses to requirements raised by competent authorities; • File project documents in accordance with internal procedures; • Keep the project database updated in accordance with internal procedures; • Write and/or review Standard Operating Procedures relevant to the department and assist, if necessary, in managing the area's training matrix; • Support other analysts in the department; • Attend Regulatory and Scientific Affairs meetings and other meetings as requested; • Participate in technical meetings with sponsors and regulatory authorities together with the Regulatory and Scientific Affairs Management, 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; • Represent the company before professional bodies and participate in specific technical groups when the topic has significant impact for the company and/or sponsors.

🎯 Requirements

• Bachelor's degree in Pharmaceutical Biochemistry, Biomedicine, Biology, Biotechnology or related fields; • Medical writing skills; • Ability to conduct meetings for scientific discussions and present results; • Advanced English; • Basic Spanish; • Advanced MS Office skills; • Training in Good Clinical Practice (GCP); • Knowledge of systematic literature review desirable; • Previous experience in medical writing for clinical research.

🏖️ Benefits

• Commuting allowance (Vale Transporte); • Parking (subject to availability); • Health insurance with no monthly premium for the employee; co-pay applies for tests and consultations; • Dental plan with co-pay; • Life insurance at no cost to the employee; • Flexible meal/food allowance; • Pharmacy discount program; • Vaccination program; • Synvia Partnership Club (discounts with educational institutions, language schools, leisure and cultural services); • Flexible time bank — holidays and commemorative dates (per internal policy); • Partnership with SESC; • Physical wellness program — TotalPass; • Day off — health professional; • Childcare allowance (per internal policy).