Regulatory Start Up Analyst And Medical Writer Ii
Current• Development of study synopses, including determination of study design and outcomes, preparation of clinical protocols, investigator brochures, and other key documents for ethical and regulatory submissions;• Conduct meetings with sponsors to discuss and coordinate regulatory and clinical development strategies;• Implemented processes within the company to conduct systematic reviews in accordance with Anvisa guideline 61/2023, the Cochrane Handbook and PRISMA guideline for the presentation of literature data in regulatory submissions. This initiative enabled the successful development of new projects and strengthened relationships with new clients;• Preparation of clinical and non-clinical modules for registration dossiers in CTD format, including development of systematic reviews of scientific literature for regulatory submission;• Preparation of technical-scientific rationales and efficacy and safety reports, synthesizing evidence from scientific literature, guidelines and applicable regulations to support regulatory approaches;• Conduct due diligence by reviewing product documentation, assessing regulatory compliance, identifying risks, and analyzing market viability to ensure safety and efficacy before approval or investment decisions;• Preparation of the complete project dossier for ethical submission, as well as follow-up of amendments, notifications, partial reports, protocol deviations or responses to pending issues;• Preparation of technical responses to the requirements and pending questions issued by the Brazilian regulatory agency;• Review standard operating procedures relevant to the department and assist in the management of the area's training system;• Mentor and guide less experienced team members on projects as needed;• Up to date with the regulations and technical requirements applicable to the Brazilian regulatory agency, as well as international guidelines for project planning, development and submission.
