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Clinical Research Associate

posted by: spj_bot

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

As a Clinical Research Associate (CRA), you will be responsible for monitoring clinical studies and ensuring compliance with study protocols, ICH‑GCP guidelines, and regulatory requirements. You will act as a key liaison between study sites and project teams, contributing to the successful execution of oncology clinical trials.solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

Key Responsibilities

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Regulatory Affairs Officer

posted by: spj_bot

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

We are looking for an experienced Regulatory Affairs Officer to provide temporary, part-time operational support for regulatory activities (BeLux).

The consultant will support the local Regulatory Affairs team with regulatory submissions, marketing authorisation lifecycle management, labelling activities, and regulatory compliance for pharmaceutical products and medical devices.

Key Responsibilities:

Job Skills

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Head of CMC Data Management

posted by: spj_bot

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

This role offers an exciting opportunity to lead and shape the Data Management strategy within a global CMC environment. As Head of CMC Data Management, you will drive data governance, lead a team of Data Managers, and prepare CMC data foundations to support future Data Science and Artificial Intelligence initiatives.

Key Responsibilities

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PV Innovation & Transformation Consultant

posted by: spj_bot

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

The successful candidate will play a key role in driving innovation, optimizing pharmacovigilance processes and improving data governance following the implementation of a new safety database platform. This position requires a strong combination of pharmacovigilance subject matter expertise, project leadership and a consulting mindset, with the ability to bridge business operations, digital technology teams and external solution providers.

Key Responsibilities

Job Skills

pharmacovigilance leadership act automation lean six sigma life sciences cross functional data data process improvement information system regulatory requirement systems business business process agile service provider communication data quality biomedical sciences continuous improvement data integrity bridge pharmaceutical operational translate business transformation timelines problem solve teamwork process optimization collaboration workflows operations digital transformation digital technology stakeholder management innovation system performance process safety monitor progress enthusiasm provider service sciences information adoption translating consulting data governance business operation validate change management requirements regulatory project scope quality management pv transformation manage track
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Medical Affairs Consultant

posted by: spj_bot

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

We are looking for an experienced Medical Affairs Consultant / Therapeutic Area Medical Lead to provide medical leadership. The role focuses on ensuring the continuity of Medical Affairs activities, driving the execution of regional medical strategies and plans and fostering effective collaboration with regional and local medical teams to support ongoing projects and business objectives.

Key Responsibilities

  • Lead and execute Medical Affairs activities within dermatology and/or rheumatology.
  • Support regional medical strategies and operational medical plans across European markets.
  • Collaborate with Medical Heads, Medical Advisors and cross-functional stakeholders.
  • Coordinate scientific activities, including advisory boards, congresses and medical education initiatives.
  • Support evidence generation projects, including Real-World Evidence (RWE) and Non-Interventional Studies (NIS).
  • Engage with external medical experts and key opinion leaders (KOLs).
  • Ensure scientific accuracy, regulatory compliance and alignment with medical governance.
  • Provide operational continuity during temporary staffing gaps.

Job Skills

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Quality Assurance Pharmacist

posted by: spj_bot

At Excelya, we combine passion, scientific excellence, and collaboration to support our clients throughout the entire drug development lifecycle. We encourage our employees to be bold, take initiative, and unlock their full potential in an international, fast-growing environment.

We are currently looking for a Quality Assurance Pharmacist to strengthen our Quality team and support pharmaceutical quality systems, product quality activities, and regulatory compliance initiatives.

Key responsibilities :

Job Skills

regulatory compliance electronic pharmacovigilance risk management risk assessments quality management system monitor quality portfolio optimization cross functional registration technology transfer pharmaceutical manufacturing collaborating systems product investigations service provider management management activities doctor of pharmacy electronic systems internal audits continuous improvement product quality pharmaceutical quality systems archiving manage quality gmp operational training programs QMS unlock product recall teamwork collaborate drug development collaboration supply chain enthusiasm manage product change control management system consulting quality assurance managing deviations quality management english good manufacturing practice root cause analysis coordinate manage audits
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Market Access & International Pricing Consultant

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.

Working within a global cross-functional environment, our Market Access & International Pricing Consultant will collaborate with Market Access, Finance and local affiliates to ensure accurate pricing data, support strategic planning and contribute to market access initiatives.

Key Responsibilities:

  • Manage and maintain international pricing databases across multiple markets.
  • Analyze pricing structures, net pricing mechanisms, discounts, rebates, and commercial agreements.
  • Perform pricing data reconciliation and quality control activities.
  • Support budgeting, forecasting, and financial planning exercises.
  • Consolidate and analyze pricing-related financial data.
  • Produce reports and insights for Finance and Market Access stakeholders.
  • Conduct data audits and cleansing activities to ensure data integrity.
  • Collaborate with local affiliates on pricing and reimbursement topics.
  • Contribute to the enhancement of pricing processes, methodologies, and tools.
  • Support selected Market Access projects, strategic analyses, and launch preparation activities.

Requirements

Job Skills

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Global Case Processing Specialist

posted by: spj_bot

About Excelya

At Excelya, we combine passion, scientific excellence, and collaboration to support our clients across the entire drug development lifecycle. As a trusted partner of leading pharmaceutical and biotechnology companies, we are looking for a Pharmacovigilance Case Processing Officer to join a global safety team and contribute to the delivery of high-quality pharmacovigilance activities in an international environment.

Missions

As a Pharmacovigilance Case Processing Officer, you will support the Global Safety team and ensure the timely and compliant management of case processing activities.

Your main responsibilities will include:

Job Skills

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Clinical Scientist Oncology

posted by: spj_bot

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

This role offers an exciting opportunity to join an Oncology Clinical Science team supporting an ongoing Phase I/II solid tumor clinical study evaluating targeted therapies, immunotherapies, and chemotherapy combinations. You will provide scientific oversight, contribute to patient-level data review, support study deliverables through database lock and Clinical Study Report (CSR) activities, and collaborate with cross-functional teams to ensure high-quality study execution.

Key Responsibilities

Job Skills

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Biomarker Assay strategy leader

posted by: spj_bot

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

This role offers an exciting opportunity to join a dynamic and ambitious team. As a Biomarker Assay Strategy Leader, you will drive biomarker assay implementation from late research stages through Proof of Concept (PoC) and beyond, ensuring alignment with biomarker plans and project objectives across the drug development lifecycle.

Key Responsibilities

Job Skills

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