Analista de Escrita Médica – Start Up

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Address sponsor requests with the required detail and support based on current legislation;

• Engage in discussions to determine the best strategies for various projects;

• Assist in assessing the feasibility of projects;

• Help identify potential risks and opportunities for projects arising from changes in legislation and/or applicable requirements;

• Conduct literature reviews for the preparation of clinical study documents, regulatory-scientific opinions, systematic literature reviews, and Investigator Brochures;

• Draft protocols and documents related to clinical studies;

• Create Investigator Brochures;

• Develop systematic literature reviews;

• Write and evaluate clinical and non-clinical modules (CTD format) of documentation for drug registration and post-registration;

• Revise prepared documents as necessary after review by project stakeholders;

• Compile complete project dossiers for submission to the CEP/CONEP System via the Brazil Platform;

• Prepare amendments, notifications, interim reports, protocol deviations, or responses to inquiries from the CEP/CONEP System;

• Respond to internal monitoring/audits conducted by the Quality Assurance department;

• Contribute to technical responses to requirements issued by regulatory bodies;

• Archive research project documents in accordance with internal procedures;

• Maintain the project database updated according to internal procedures;

• Write and/or review Standard Operating Procedures relevant to the department and assist, if necessary, in managing the training matrix for the area;

• Support other analysts in the department;

• Attend Regulatory and Scientific Affairs meetings as requested;

• Participate in technical meetings with sponsors and regulatory bodies alongside the Regulatory and Scientific Affairs Management when necessary;

• Stay informed about regulations and technical requirements applicable to the Brazilian regulatory agency and international guidelines for project planning, execution, and submission;

• Represent the company at industry associations and participate in specific technical groups when topics are of significant impact for the company and/or sponsors.

⛳️ Requirements

• Bachelor's degree in: Pharmacy-Biochemistry, Biomedicine, Biology, Biotechnology, or related fields;

• Proficient medical writing skills;

• Ability to conduct meetings for scientific discussions and presentation of results;

• Advanced proficiency in English;

• Basic proficiency in Spanish;

• Advanced knowledge of the Office Suite;

• Training in Good Clinical Practices (GCP);

• Desirable knowledge in systematic literature review;

• Previous experience in medical writing for clinical research.

🏝️ Benefits

• Transportation allowance;

• Parking (subject to availability);

• Health plan at no monthly cost to the employee, with co-payment for exams and consultations;

• Dental plan with co-payment for monthly fees;

• Life insurance at no cost to the employee;

• Flexible meal/food allowance;

• Pharmacy partnership;

• Vaccination program;

• Synvia Partnership Club (Educational Institutions, Languages, Leisure, and Culture);

• Flexible Hours Bank – holidays and commemorative dates (subject to internal policy);

• SESC partnership;

• Physical health program - TotalPass;

• Day Off – Health Professional;

• Childcare assistance (subject to internal policy).