Medical Device Clinical Research

SESHASENA REDDY MULI

Boston, MA +1-857-***-**** ****.*@************.*** Linkedin.com

EDUCATION

Northeastern University, Boston, MA, GPA: 4 April 2026 Master of Science in Regulatory Affairs

• Coursework: Regulatory Compliance and Strategy, Medical Device Development: Quality System Regulation in Medical Device Design, 510(k) Submissions, PMA, DMF, 21CFR parts 210 & 211 and 21 CFR 820 Jawaharlal Nehru Technological University of Anantapur, India, GPA: 3.7 June 2023 Doctor of Pharmacy

• Coursework: Pharmaceutics, Pharmacology, Medicinal Chemistry, Pharmaceutical Analysis and Clinical Research EXPERIENCE

Altruist Technologies Pvt Ltd, Hyderabad, India Sep. 2022 - Aug 2023 Prescription Digitizer Intern

• Managed 100+ daily prescription authorizations in the Pharmaceutical Industry, ensuring ISO 13485 compliance.

• Optimized prescription workflows using EHR systems, SharePoint, and Microsoft Excel; reduced authorization errors by 25% via statistical process control.

• Supported external audits, conducting risk assessments of prescription filings; generated audit reports using Microsoft Excel and technical writing skills.

• Developed training on digitization best practices and data integrity for improved team efficiency by 50% demonstrated regulatory knowledge, problem-solving, and risk assessment using data analysis in the Pharmaceutical Industry. Aims Hospitals, Andhra Pradesh, India

Clinical Pharmacist Intern Jun. 2022 - Jul 2023

• Managed a GLP-compliant MTM program supporting clinical trial data management and annual review, ensuring data integrity.

• Extracurricular Activity: Volunteered at a local clinic, assisting with patient data entry.

• Evaluated 500+ patient medical records, identifying drug interactions using statistical software for quantitative analysis and database management; conducted primary research data collection.

• Developed patient counseling programs, reducing adverse events by 20%, demonstrating computer literacy and improving patient safety; conducted clinical trial data collection and analysis. Clinical Research Coordinator Jan. 2022 - Jun 2022

• Coordinated clinical trial activities, including study startup, site initiation, and patient enrollment.

• Managed and maintained clinical trial documentation, ensuring compliance with regulatory requirements.

• Collected, entered, and verified patient data in electronic data capture (EDC) systems with a focus on accuracy and GCP compliance.

• Ensured adherence to FDA, ICH-GCP, and Institutional Review Board (IRB) guidelines throughout the study lifecycle.

• Supported site monitoring visits by preparing study-related documents and ensuring adherence to protocols. SKILLS

• Technical Skills: Knowledge of GMP, FDA, QSR, CAPA, SOP, GLP, ICH, Good Clinical Practice (GCP), Smartsheet, WHO guidelines, EU MDR MDD, Quality Management System (QMS), Document Management, Quality Assurance, CAPA, International Conference on Harmonization (ICH), CMC, eCTD, SharePoint, OneDrive, Outlook, Case Report Form, MS Office Suite, Microsoft Word, Microsoft Excel, Trial Master File, ISO 13485, ISO 14971, ISO 14155, PowerPoint and Adobe Acrobat PDF. 510(k) submissions, (PMA) applications, Informed Consent Form and Case Report Form.

• Soft Skills: Detail-oriented, excellent organization and time management skills, Strong learning ability, Strong analytical skills, problem-solving, Professional writing, Exceptional interpersonal skills, Excellent verbal communication and writing skills, Leadership Skills, ability to work independently, Project Management skills, Ability to multi-task and prioritize responsibilities. PROJECTS

• Project titled “An observational study of Effective pain management in Total Knee Replacement (TKR) Patients at Apollo super specialty Hospitals”.

• Project titled “Phase 3 study to evaluate the safety and efficacy of Galnobax in treating diabetic foot ulcers”.

• Conducted a detailed analysis of FDA warning issued to Anicare Pharmaceuticals Pvt. Ltd. for CGMP violations and adulteration.

• Delivered an in-depth presentation on the strategic perspective of Surveil Drug-Coated Balloon Medical Device Submission.

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