SYNVIA

Junior Medical Writing Analyst, Start-up

SYNVIA

full-time

Posted on:

Location Type: Remote

Location: Brazil

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Job Level

Junior

Tech Stack

Google Cloud Platform

About the role

  • 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.
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).
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
medical writingsystematic literature reviewclinical study protocolsCTD format documentationproject feasibility analysisrisk assessmentregulatory submissionsamendments preparationSOP writingdata archiving
Soft Skills
leadershipcommunicationteam collaborationdetail-orientedproblem-solvingpresentation skillsadaptabilitytechnical discussion facilitationstakeholder engagementtraining support
Certifications
Bachelor's degree in Pharmacy-BiochemistryBachelor's degree in BiomedicineBachelor's degree in BiologyBachelor's degree in BiotechnologyGood Clinical Practice (GCP) training