Medical Writing Analyst – Clinical Research (Mid-level)
SYNVIA
full-time
Posted on:
Location Type: Remote
Location: Brasil
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Tech Stack
About the role
- Handle sponsors' requests with the required level of detail and grounding in 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, regulatory-scientific opinions and Investigator Brochures;
- Draft protocols and related documents for clinical studies;
- Prepare Investigator Brochures;
- Revise and adapt prepared documents, when necessary, after 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 monitoring visits/internal 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;
- Maintain the project database up to date according to internal procedures;
- Review Standard Operating Procedures (SOPs) relevant to the department and assist, if necessary, in managing the area's training matrix;
- Participate in Regulatory and Scientific Affairs meetings and whenever requested;
- Participate in technical meetings with sponsors together with Regulatory Affairs and Start-up 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.
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 for drafting clinical and non-clinical modules to compose a drug registration dossier.
- Knowledge of CTD (Common Technical Document).
- Strong writing skills.
- Advanced English.
- Basic Spanish.
- Advanced Microsoft Office skills.
- Training in Good Clinical Practice (GCP).
Benefits
- Transportation voucher (Vale Transporte);
- Parking (subject to availability);
- Health plan with no monthly fee for the employee, with copayments for exams and consultations;
- Dental plan with monthly copayment;
- Life insurance at no cost to the employee;
- Flexible meal/food allowance;
- Pharmacy discount program;
- Synvia Partnership Club (education, language schools, leisure and culture);
- Partnership with SESC;
- Physical health program – TotalPass;
- Day Off – health professional;
- Childcare assistance (per internal policy).
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical protocols writingsystematic literature reviewsdrug registration dossier compositionCTD (Common Technical Document)project feasibility assessmentsrisk identificationdocument revisionproject database maintenanceStandard Operating Procedures (SOPs) reviewregulatory submissions
Soft skills
strong writing skillsattention to detailcommunicationcollaborationproblem-solvingorganizational skillsadaptabilitytechnical response contributionstakeholder engagementtraining assistance
Certifications
Bachelor's degree in Pharmacy-BiochemistryBachelor's degree in BiomedicineBachelor's degree in BiologyBachelor's degree in BiotechnologyGood Clinical Practice (GCP) training