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Senior CMC Regulatory Technical Writer

posted by: spj_bot

About the Job

Join Excelya as a Senior CMC Regulatory Technical Writer, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

You will play a key role in translating complex CMC scientific and technical data into clear, concise, and compliant regulatory documentation (Module 2.3 and Module 3 of the CTD), aligned with global health authority requirements.

This is a hands-on technical writing position working in close collaboration with CMC regulatory strategists and cross-functional technical teams (drug substance, drug product, analytical, manufacturing, QA). The role does not include regulatory strategy ownership but requires strong regulatory understanding.

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Quality Document Manager

posted by: spj_bot

About the Job

At Excelya, we uphold the values of Audacity, Care, and Energy in everything we do. We are seeking a dedicated Quality Document Manager to join our Quality Assurance team.

As part of the R&D Quality Assurance team, you will support the Quality Management System (QMS) dedicated to Research and Translational Medicine activities within Preclinical Data Management.

You will contribute to maintaining and improving the quality documentation framework, ensuring compliance with internal policies and applicable regulations. This role offers strong exposure to cross-functional R&D teams in a structured and scientifically driven environment.

Main Responsibilities

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Senior Associate Clinical Contracts & Budgets

posted by: spj_bot

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities:

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Data Quality Management Consultant

posted by: spj_bot

Why Join Us?

At Excelya, we are committed to excellence in healthcare, and we invite you to be part of our dedicated team where your expertise can make a significant impact.

As a young, ambitious health company with over 900 talented professionals, we strive to be Europe's leading mid-size CRO, delivering the best employee experience. Our integrated service model enables you to engage in diverse projects, working alongside industry experts to enhance scientific knowledge and improve the patient journey.

About the Job

The Data Quality Management role is essential in ensuring that our data meets the highest standards for quality and integrity throughout the research and pharmaceutical development process.

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Project Management Officer - Digital & AI Transformation (R&D)

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Data & AI. You will play a critical part in driving innovation and making an impact in the clinical research space while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

Job Skills

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International Regulatory Affairs Officer - Advertising & Promotion

posted by: spj_bot

About the Job

Excelya is seeking an experienced International Regulatory Affairs Officer specializing in Advertising and Promotion. In this pivotal role, you will be part of a dedicated team that embodies Audacity, Care, and Energy, contributing to our mission of ensuring compliance and excellence in promotional practices across global markets.

Your expertise will drive the development and implementation of regulatory strategies for advertising and promotional materials, ensuring adherence to regulations across various international jurisdictions while aligning with our corporate goals.

Main Responsibilities:

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Clinical Research Director I&I

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. As the Clinical Research Director for Inflammation and Immunology (I&I), you will lead critical clinical programs and play a pivotal role in advancing innovative therapies for patients.

This remote role empowers you to influence clinical strategy significantly, ensuring that we not only meet regulatory standards but also create optimal study designs that translate into successful patient outcomes.

Main Responsibilities:

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Clinical Evaluation Manager Medical Devices

posted by: spj_bot

About the Job

At Excelya, we embody the values of Audacity, Care, and Energy as we strive to develop innovative solutions in a fast-paced, collaborative environment. We are seeking a skilled Medical Writer to join our dedicated team. This role offers the opportunity to create impactful documentation that plays a crucial role in the medical research and development process.

As a Medical Writer, you will be responsible for developing high-quality, scientifically accurate, and compliant documents to support clinical studies and regulatory submissions, ensuring that the information is clear, concise, and accessible to a wide range of stakeholders.

Main Responsibilities:

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Medical Affairs Lead - Medical Devices

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. As the Head of Medical Affairs, you will lead our efforts in shaping the medical strategy and direction for our product portfolio, ensuring that our initiatives align with our mission of advancing patient care through innovative solutions.

This position offers an exceptional opportunity to work at the intersection of science and business, leading a dedicated team while collaborating cross-functionally to achieve our goals.

Main Responsibilities

Medical & Scientific Leadership

Job Skills

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Clinical Scientist I&I

posted by: spj_bot

About the Job

At Excelya, we embrace our core values of Audacity, Care, and Energy to shape the future of clinical research. As a Clinical Scientist in Immunology & Inflammation (I&I), you will collaborate closely with a talented multidisciplinary team to drive the success of our clinical trials.

This position provides an opportunity to engage in innovative research and contribute to studies aimed at addressing critical medical needs. You will be integral to ensuring the smooth execution of clinical trials while maintaining the highest scientific and ethical standards.

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