Clinical Documentation Analyst

Description

Job Summary: Professional to assist in drafting responses to monitoring activities, evaluating analytical methods and medications, and reviewing standard operating procedures. Key Highlights: 1. Collaborate in the mission of improving people's lives. 2. Work in a modern, dynamic, and innovative environment. 3. A youthful, innovative culture passionate about the company’s mission. To join our team, we seek professionals who wish to contribute to our mission of **improving the lives of an increasing number of people.** If you have an innovative profile, think outside the box, and enjoy working in a modern and dynamic environment, this opportunity is for you. Join us on this journey. **\#VemSerSynvia** **Responsibilities and Duties** **We count on you to:** * Assist in drafting responses to sponsor monitoring activities, regulatory agency inspections, and internal Quality Assurance (QA) monitoring activities; * Evaluate analytical methods validated by the company, indicating necessary adjustments per current regulations, including RDC No. 27/2012, RDC No. 166, RDC No. 31, RDC No. 318, EMA, FDA, ICH M10, ICH Q2(R2\), DOQ\-CGCRE\-009, and ISO 17025; * Assist in developing and finalizing action plans arising from non-conformance reports and opportunities for improvement; * Draft and review Standard Operating Procedures (SOPs), aiming to maintain Good Laboratory Practices (GLP); * Submit study protocols for signature by responsible parties; * Evaluate medications administered during the clinical phase for assay execution, per RDC No. 27/2012, EMA, FDA, and ICH M10; * Accompany sponsors during on-site monitoring visits; * Assist in drafting responses to technical requirements and/or inspection reports; * Assist in translating laboratory SOPs into English and Spanish; * Archive, control, and request new Logbooks and RQs; * Register laboratory analytical supplies upon request from management; * Register ELD (Long-Term Study Duration Assessment); * Control and evaluate Certificates of Analysis (CoA); * Draft and/or review concentration spreadsheets for submission to the statistics department and/or sponsor; * Draft and/or review analytical reports, protocols, errata, protocol amendments, and protocol deviations, per applicable regulations, legislation, official compendia, and technical notes issued by ANVISA and other regulatory agencies. **Requirements and Qualifications** **What we seek:** * Completed High School education; * Proficiency: Microsoft Office Suite (Word, Excel, PowerPoint, Outlook); * Experience in administrative roles, with strong document management skills and spreadsheet development expertise; * Preferred: Currently pursuing undergraduate studies in Nursing, Biochemistry, Pharmacy, Chemistry, Biomedicine, Chemical Engineering, Biology, or related fields. **Additional Information** **Work Location:** * Campinas/SP and Paulínia/SP. **Working Hours:** * 08:00–17:00 \- Mon–Fri **What we offer:** * Transportation Allowance; * Parking (subject to availability); * Health Insurance plan at no cost to the employee, with co-payment for exams and consultations; * Dental Insurance plan with monthly co-payment; * Life Insurance at no cost to the employee; * Flexible meal/food allowance; * Pharmacy Benefit Program; * Synvia Partnership Club (Education Institutions, Language Schools, Leisure, and Culture); * SESC Partnership; * Physical Health Program – TotalPass; * Day Off – Healthcare Professionals; * Childcare Assistance (per internal policy). We are a company with a youthful, innovative culture passionately committed to our mission of **improving the lives of an increasing number of people.** Present in Campinas, Paulínia, and São Paulo, we support the pharmaceutical industry in developing and registering new medications and provide diagnostic services to laboratories across Brazil. **OUR WAY OF WORKING** With 20 years of experience in health and technology and over 800 employees, our culture is guided by core values: **integrity, ownership, and innovation and excellence.** We believe in the positive impact of our work through our teams and services; therefore, we encourage professional development among our employees and offer Internship Programs, Apprenticeship Programs, and Career Acceleration Programs. Do you identify with Synvia? Let’s together improve the lives of an increasing number of people?