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Senior Regulatory Affairs CMC (ADC/Biologics)

posted by: spj_bot

Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.Our global team of experts are the powerful force behind our success. When you work at Excelya, you become part of an international network that nurtures your talent, builds your skills and recognizes your value.

Our client is looking for a senior regulatory consultant to provide strategic and operational Regulatory CMC leadership support for a global Antibody-Drug Conjugate (ADC) biologics program. The selected consultant will play a critical role in leading global Regulatory CMC activities associated with Marketing Authorisation Applications (MAA) and/or Biologics License Applications (BLA), with a focus on global regulatory CMC strategy and matrix-management leadership.

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Senior Regulatory CMC (Small Molecule)

posted by: spj_bot

Join Excelya, a dynamic and innovative company committed to excellence and collaboration in the field of translational research.Our global team of experts are the powerful force behind our success. When you work at Excelya, you become part of an international network that nurtures your talent, builds your skills and recognizes your value.

The selected consultant will play a critical role in leading the global Regulatory CMC strategy for a small molecule product, with a particular focus on Module 3 preparation, Marketing Authorization Applications, global health authority interactions, and regulatory submission readiness

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Data Steward (Preclinical field)

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.

As a Data Steward, you will play a key role in managing and ensuring the quality of research data within the preclinical data team for one of our pharmaceutical clients. You will join an existing team that is expected to grow, as we continue to support our client across an expanding range of projects.

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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.

Main Activities:

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Safety Database Administrator

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

We are seeking a Safety Database Administrator to join our Pharmacovigilance team. In this pivotal role, you will ensure the effective management and operation of our safety database, contributing to the overall quality and compliance of our pharmacovigilance activities.

Main Responsibilities:

Job Skills

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Safety Database Officer

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.

Main activities :

Job Skills

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Technical Data Manager I

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

We are seeking a Technical Data Manager, who will be responsible for performing Technical Data Management tasks per client work orders to high regulatory standards and Excelya Group SOPs.

Main Responsibilities:

Job Skills

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Senior Medical Writer

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

We are seeking a Senior Medical Writer to produce medical writing deliverables (both regulatory and medical communication documents).

Main Activities:

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Data Manager CMC

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

We are seeking a Data Manager – CMC (Chemistry, Manufacturing, and Controls) to support our commitment to high-quality products. In this vital role, you will oversee and ensure the integrity of data generated. You will work closely with research and project teams to deliver actionable insights through rigorous data management practices.

Main Activities:

Organize and improve data quality per rules set by Data Owner.

Job Skills

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Project Data Manager

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

We are seeking an Project Data Manager to strengthen our commitment to delivering high-quality products. In this pivotal role, you will lead quality assurance processes, ensure regulatory compliance, and drive continuous improvement initiatives.

Main Activities:

Job Skills

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