Junior Medical Writing Analyst, Start-up

Role Overview

• 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.

Requirements

• Bachelor's degree in Pharmacy-Biochemistry, Biomedicine, Biology, Biotechnology, or related fields;
• Medical writing skills;
• Ability to lead scientific discussions and present results;
• Advanced English;
• Basic Spanish;
• Advanced Microsoft Office skills;
• Training in Good Clinical Practice (GCP);
• Desirable: knowledge of systematic literature review methodology;
• Prior experience in medical writing for clinical research.

Tech Stack

• Google Cloud Platform

Benefits

• Transportation allowance;
• Parking (subject to availability);
• Health insurance with no monthly fee for the employee; co-payments for tests and consultations apply;
• Dental plan with employee co-payments;
• Life insurance at no cost to the employee;
• Flexible meal/food allowance;
• Pharmacy discount/partnership;
• Vaccination program;
• Synvia Partner Club (education, language schools, leisure and cultural discounts);
• Flexible hours bank – holidays and special dates (subject to internal policy);
• Partnership with SESC;
• Physical health program – TotalPass;
• Day Off – Health Professional;
• Childcare assistance (subject to internal policy).