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Manager Medical Writing

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 the Medical Writing department. You will play a critical part in driving innovation and making an impact in the Medical Affairs space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

Job Skills

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Senior Redaction and Public Disclosure Specialist

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 Medical Writing department. 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

  • Perform redaction and anonymisation of clinical documents (CSRs, Protocols, IBs) and ensure consistency, quality, and auditability.
  • Prepare, format, and submit documents for public disclosure portals (EMA, Health Canada).
  • Coordinate timelines and deliverables across multiple projects; ensure on-time completion.
  • Collaborate with cross-functional teams (Medical Writing, QA, Regulatory, Biostats, Data Management, Clinical) and interact with clients as needed.
  • Train, mentor, and provide backup support to RPDS team members; review and approve their redaction work.
  • Support project management, sponsor communication, and contribute to SOPs, processes, and financial offer preparation.

Requirements

About You

Job Skills

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Senior Quality Control Specialist

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 Medical Writing department. You will play a critical part in driving innovation and making an impact in the Medical affairs space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

Job Skills

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Senior Electronic Document Specialist

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 Medical Writing department. You will play a critical part in driving innovation and making an impact in the Medical affairs space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

The Senior Electronic Document Specialist (SeDS) takes a leadership role in coordinating and conducting quality control checks on prepared documents. With experienced and well-defined input, the SeDS ensures the accuracy, completeness, and submission readiness of documents, including cross-references, bookmarks, and navigations.

Job Skills

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Principal Medical Writer USA

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 Medical Affairs. 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 responsabilities :

Job Skills

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Statistical Programmer

posted by: spj_bot

About the Role

Excelya is on the lookout for a talented Statistical Programmer to join our dynamic team. We are dedicated to upholding our core values of Audacity, Care, and Energy, and we believe that each member of our team plays a pivotal role in advancing clinical research through precise and insightful statistical analysis.

As a Statistical Programmer, you will leverage your expertise to analyze and interpret complex clinical data, ensuring our studies meet the highest standards of quality and compliance. This role not only allows you to showcase your programming skills but also provides the opportunity to collaborate with a diverse group of professionals committed to making a tangible impact in healthcare.

Key Responsibilities:

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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Clinical Research Associate - Oncology

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 Clinical Operations, particularly in the field of Oncology. As a Clinical Research Associate specializing in this area, you will play a crucial role in ensuring the successful conduct of oncology clinical trials, while supporting innovative cancer therapies that make a real difference in patients' lives.

Main Responsibilities:

Job Skills

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Senior Medical Writer

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 Medical affairs. 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

  • Act as lead author for a range of regulatory and scientific documents (clinical protocols, Investigator Brochures, CTD modules, informed consent forms, etc.).
  • Coordinate cross-functional input (clinical, regulatory, biostatistics, data management, etc.) to ensure consistency and scientific accuracy of all deliverables.
  • Oversee and review the work of external vendors or contributing writers to ensure quality and compliance.
  • Ensure documents adhere to company SOPs, style guides, and international regulatory standards (EMA, FDA, ICH).
  • Manage timelines, planning, and document reviews efficiently to support submission milestones.

Requirements

About You

Job Skills

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Clinical Innovation Project 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.

The Clinical Innovation Project Manager will play a pivotal role in driving innovation within clinical trials, enhancing processes, and implementing best practices to improve study designs and outcomes. This is an excellent opportunity for proactive individuals who are passionate about advancing clinical research through innovative solutions.

Main Responsibilities

Job Skills

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