Overview

NSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and expertise in scientific research, development, manufacturing, sales, and marketing of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs), and branded pharmaceutical products, adding value to human and animal health.

Responsibilities

Planning, designing, organization, supervision of conduct and reporting of clinical trial contracted to Clinical Research Organizations (CRO) to enable studies execution within the planned timelines and in compliance with current GCP and other applicable requirements. The main focus is on pharmacokinetic (PK) and bioequivalence (BE) trials. Multicenter clinical trials and phase II and III trials may also be required with the necessary support.
- Support the design and day-to‑day management of clinical/preclinical trials according to plan and in compliance with applicable laws, regulations, and guidelines (ICH, EMA, FDA, and others).
- Prepare and maintain the appropriate documents to support clinical strategy,



study rationale, and justifications, and communicate effectively with the rest of the team involved (CRA/CTA) as well as with the reporting line Team Leader/Manager.
- Participate in the selection and coordination of CROs and other external vendors, and support follow‑up of contracted activities to help ensure that activities are conducted in accordance with agreed requirements (cost, quality, and time).
- Support the review of the necessary documentation before (e.g. Protocol, ICF, etc.), during (e.g. Monitoring, etc.) and at the end (e.g. Study Report, etc.) of clinical trials.
- Coordinate and follow up internal activities and procedures related to study conduct and operational execution of clinical trials (e.g. investigational medication shipment, etc.), ensuring alignment with internal processes.
- Support interactions with Health Authorities, including Scientific Advice procedures, Deficiency

📌 Clinical Development (Azuqueca de Henares)
🏢 Chemo
📍 Azuqueca de Henares