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Senior Regulatory CMC Project lead

posted by: spj_bot

About the Job

At Excelya, where Audacity, Care, and Energy are at the core of everything we do, we are seeking a Senior CMC Regulatory Consultant specializing in small molecules lifecycle management to join our dynamic team.

This role involves providing expert regulatory input throughout the lifecycle of small molecule products, from development to post-marketing activities. As a Senior Consultant, you will work closely with cross-functional teams to ensure robust regulatory strategies, compliance, and submission excellence.

The main objectives of this role are to lead the CMC Regulatory strategy of a small molecule asset (late phase; MAA under preparation) within a truly global scope and to manage and deliver the CMC Dossier with the support of the technical writing team within the Regulatory CMC.

Main Responsibilities:

Job Skills

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Regulatory Affairs Specialist

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.

Provide operational regulatory support to a pharmaceutical affiliate in Greece, with primary responsibility for the maintenance and lifecycle management of national Marketing Authorisations (MAs), particularly for an oncology product. The role also supports regulatory activities across several European distributor markets.

Main Responsibilities:

Job Skills

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Oracle Programmer (1)

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 Management. 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.

The Oracle Programmer is responsible for providing Oracle Programming input for Data Management activities dedicated to one Sponsor. They are responsible for ensuring all clinical programming aspects per Client’s SOPs are delivered to high quality.

Main Responsibilities

•Work closely with the different study stakeholders internally

•Responsible for programming using Oracle tools (DMW, LSH)

•Good understanding of SDTM & Data set generations as per the specifications in DMW.

•Responsible for setting up for external data vendors integration from specifications in DMW.

•Responsible for Transformation mapping as per the specifications.

•Responsible for managing external data loading and integrations in DMW.

•Responsible for VC/PD programming in DMW

Requirements

About You

Job Skills

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FP&A Analyst

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 Finance, 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.

 

Our Mission: “To contribute to the wellbeing of humanity, developing new ways to cure” The Vision: Excelya aims to become the leading mid-size CRO in its market with the best employee experience.

Excelya Group has embarked on an ambitious growth strategy for the next five years, both organically and external growth, which lead to a significant ongoing evolution of the business. As such, the Group has already developed strong FP&A processes and tends to develop them any further.

We are looking for a Finance professional passionate about Business partnership , and financial automation, willing to help transform FP&A into a highly efficient and value-added function.

 

Main Responsibilities

FP&A’s responsibilities are as follows:

Job Skills

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Global Medical Advisor

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.

At Excelya, we are committed to delivering innovative clinical research solutions across Europe. As a Medical Advisor, you will play a pivotal role in providing expert medical and scientific guidance to support several projects internaly.

Key Responsibilities:

  • Provide medical expertise and advice throughout clinical development processes.
  • Support the preparation and review of medical and scientific content including manuscripts, posters, and presentations.
  • Engage with cross-functional teams to ensure scientific accuracy and relevance of clinical trial materials.
  • Assist in medical training, promotional material review, and respond to medical inquiries.
  • Stay up to date with therapeutic area trends and scientific advancements.

Requirements

Job Skills

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Pharmacovigilance Project Manager

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.

In this role, you will combine operational PV expertise with project coordination responsibilities to ensure patient safety and regulatory compliance throughout the product lifecycle.

Main Responsibilities:

  • Manage and oversee pharmacovigilance case processing activities from receipt to reporting.
  • Collect, assess, document, and follow up on adverse event reports from multiple sources.
  • Perform quality review and medical consistency checks of safety cases prior to submission.
  • Support local signal detection activities and contribute to safety monitoring initiatives.
  • Participate in literature surveillance and regulatory intelligence activities.
  • Contribute to periodic safety reports and monthly PV activity reporting.
  • Collaborate with Global Safety, Medical Information, Clinical Teams, and external partners.
  • Maintain complete and inspection-ready PV documentation, tracking, and archiving.
  • Support the review and continuous improvement of local PV procedures and processes.
  • Act as a key PV contact, ensuring clear communication, escalation, and stakeholder management.

Requirements

Job Skills

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HR Officer

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.

We are looking for an HR officer to support a dynamic environment undergoing continuous change and transformation. This role requires a hands-on HR professional with strong project management capabilities and a broad understanding of all key HR disciplines.

Key Responsibilities

  • Lead and contribute to cross-functional HR projects within a fast-paced and evolving industrial environment.
  • Partner with managers and employees on a wide range of day-to-day HR matters.
  • Manage employee administration processes throughout the employee lifecycle (onboarding, changes, offboarding).
  • Ensure compliance with labor law, employment regulations, company policies, and collective agreements.
  • Support learning and development initiatives, including training plan deployment and monitoring.
  • Assist with recruitment activities and support talent acquisition needs when required.
  • Coordinate and validate payroll-related data, liaising with payroll teams to ensure accuracy.
  • Monitor, analyze, and report on key HR metrics to support business decision-making.

Requirements

Profile

Job Skills

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Clinical Trial Operations Specialist

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 combines operational excellence, clinical trial coordination, and regulatory compliance, playing a key role in ensuring the seamless execution of clinical studies across a global environment. Ideal for a highly organized professional passionate about clinical operations, stakeholder collaboration, and delivering high-quality trial support.

Main Responsibilities:

Job Skills

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Chef de Projet RWE

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. 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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Technical Data manager

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 Management. 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.

The Technical Data Manager is 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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