Senior Seo Data Science Specialist

buscojobs Brasil; Rio de Janeiro; Presencial; BRL 100.000 - 150.000; Tempo integral

Resumo da oferta

A global healthcare company is seeking a Senior Regulatory Specialist in Rio de Janeiro, Brazil. This role involves maintaining compliance with regulatory standards, coordinating study submissions, and acting as the main contact for investigative sites. Ideal candidates should have a degree in life science or equivalent and at least 3 years of relevant experience. The position offers an opportunity to work in a dynamic environment and contribute to clinical research success.

Qualificações

• University/College degree (life science preferred) or certification in a related field.
• Strong working knowledge of ICH guidelines and regulatory requirements.
• 3+ years experience in clinical development or regulatory process.

Responsabilidades

• Maintain regulatory compliance and coordinate submissions.
• Act as primary contact for investigative sites.
• Ensure high quality documents for site activation.

Conhecimentos

Knowledge of ICH guidelines

Regulatory Affairs

Clinical research

Formação académica

University/College degree in life science

Descrição da oferta de emprego

Senior Regulatory Specialist

Job Overview:

Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site Readiness team and that documentation meets the specifications required by applicable regulations and sponsor. Proactively interacts with EC/IRB/Third body/Regulatory Authorities to provide guidance regarding requirements. Maintain awareness of current regulatory standards related to submissions. Serve as local expert in project start-up activities for a particular country or region. Act as a ‘knowledge resource’ to mentor and train new hires and less-experienced department colleagues if suitable.

Summary of Responsibilities:

• Maintain awareness of regulatory legislation, guidance, and practice in the assigned countries.
• Coordinate, collect and organize data and information required by EC/IRB/Third body/Regulatory Authority including but not limited to the preparation of study documentation such as the country application form and cover letter for sponsor review as applicable.
• Compile and prepare routine submission filed to IRB/IEC/Third body/Regulatory Authorities (e.g., INDs/CTAs) and liaise with them as applicable regarding submission/approval.
• Liaise with internal and external vendors in the generation of Regulatory Authority submissions (as applicable).
• Perform a review of final submission documents as applicable.
• Ensure that all assigned start-up and maintenance activities are on track, in accordance with client expectations and budget and in compliance with applicable laws and guidelines, regulatory requirements, ICH/GCP, SOPs and quality standards.
• Prevent and escalate study issues appropriately and in a timely fashion.
• Perform other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable).
• In Country specific tasks (Global):
• Serve as primary contact for investigative sites and ensure documents required are collected in a timely manner.
• Collect and track all the necessary documents required and perform a quality review, formatting, and compilation of the final documents for effective and compliant site activation and maintenance without supervision.
• Ensure high quality documents are filed and systems are updated on an ongoing and timely basis, making Fortrea ready for an audit at any time.
• Participate in team and project meetings as applicable.
• When needed, assist in the strategy definition for Site Activation and provide accurate projections and timelines to study teams.
• Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites.
• May support the negotiation of site contracts and budgets with sites, if applicable and track progress of contract and budget milestones/developments, intervening and escalating as appropriate.
• Proactively identifying and escalating to Submission Leads any risk to meeting deliverables.
• Notify the Submissions Lead of hours identified as Out-of-Scope or overburn.
• Clinical Trials Information System (CTIS) tasks (specific centralized role for EU):
• Assist in the upload of submission documentation to, interacting with and monitoring of all notifications and alerts in CTIS to ensure all milestones and events for the trial are met within the timelines mandated.
• Performs all other duties as needed or assigned.

Qualifications (Minimum Required):

• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 2 years' work experience in clinical research, including a strong working knowledge of the ICH guidelines and RA, IRB/IEC regulations will be considered.

Experience (Minimum Required):

• Minimum of 3 years of experience in clinical development or start-up/ regulatory process.
• Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.
• Demonstrated understanding of research protocol requirements and proven ability to communicate them/educate others about them.

Physical Demands/Work Environment:

Data Science Intern – Fraud Decision Sciences

About This Opportunity:

As a Fraud Business Analyst Intern, you will play a key role in strengthening our fraud defenses by supporting process audits, rule tuning, and data-driven investigations. This role focuses on validating the effectiveness of existing Robotic Process Automations (RPAs), Accertify rules, and anomaly detection signals. You will work closely with Fraud Technology, Decision Sciences, and Anomaly Detection teams to review logic, test controls, and recommend improvements.

This position is ideal for a detail-oriented individual with strong analytical skills and a passion for fraud prevention and operational risk reduction.

Why Join InComm?

• Paid Internship
• Real-world experience with a leading global company
• Mentorship, professional development, and networking opportunities
• Discover highlights from our internship program on Instagram — follow us @InCommInterns

Responsibilities:

• Assist in auditing and validating existing fraud rules configured in the Accertify platform
• Support quality assurance reviews of RPAs related to fraud monitoring and decision-making
• Collaborate with the Anomaly Detection team to analyze triggers and evaluate false positives/negatives
• Help design and test Splunk dashboards and data visualizations for fraud alerts and system monitoring
• Document and report gaps or inefficiencies in current detection logic or process automations
• Perform basic root cause analysis of anomalous behavior and support process remediation
• Participate in fraud case reviews, helping to translate operational observations into structured findings

Qualifications:

• Pursuing a degree in Business Analytics, Finance, Information Systems, Criminal Justice, or a related discipline within your penultimate or final year of study.
• Above average academic track record
• Strong attention to detail and a process-oriented mindset
• Exposure to data analysis tools (e.g., Excel, SQL, Python) and visualization platforms (e.g., Power BI, Splunk)
• Interest in fraud prevention, financial crimes, or enterprise automation
• Ability to communicate clearly and professionally, both in writing and verbally
• Proficiency with the English language
• Must be self-motivated, ability to prioritize effectively and not shy away to seek guidance when you are blocked on a task
• Ability to work with large teams; Willing and capable of learning new tools and technologies

InComm provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin, citizenship, veteran’s status, age, disability status, genetics or any other category protected by federal, state, or local law.