Job Title: Senior Medical Monitor

Location: EU/Non EU

Type: Remote, Freelance

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:

About the Job

Join Excelya as Clinical Logistic Supply Manager, 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. 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 :

Study Start-Up Coordination : Participation in study launch meetings, organization of internal evaluation committees, drafting of Scope of Work/Request for Proposal (SoW/RFP), and development of timelines with ongoing tracking.

CRO Selection & Contracting : Involvement in CRO selection (proposal analysis, bid defense meetings), budget estimation, financial/legal negotiation, and follow-up on contract approvals.

CRO Oversight: Leading the CRO kick-off meeting, reviewing user documentation, managing technical specifications, and coordinating input from internal stakeholders.

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.

Main Responsibilities

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 Pharmacovigilance. 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:

• Supervise pharmacovigilance case management outsourced to assigned platform(s)
• Respond to case-related emails and inquiries from external service providers
• Monitor case processing timelines and investigate any delays in reporting or transmission
• Participate in weekly quality control of data entry, MedDRA coding, and narrative writing
• Support the review and validation of clinical study case narratives for inclusion in study reports
• Contribute to the reconciliation of PV cases with business partners per Safety Data Exchange Agreements (SDEAs)
• Oversee reconciliation of cases with clinical databases managed by outsourced providers
• Collaborate closely with cross-functional and global teams to ensure compliance and data integrity

Requirements

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 :

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 :

About the Job

Excelya is seeking a talented Regulatory Affairs Officer specializing in Advertising and Promotional Materials. At Excelya, we prioritize Audacity, Care, and Energy in our professional endeavors, supporting our mission to deliver high-quality healthcare solutions.

As a Regulatory Affairs Officer, you will play a key role in reviewing and approving promotional materials to ensure compliance with applicable regulations. You will work closely with marketing and medical teams to develop strategies that meet both compliance standards and business objectives, creating impactful messaging for our products.

Main Responsibilities:

• Provide regulatory guidance on the promotion of pharmaceuticals and/or medical devices in France.
• Manage the review process for promotional, institutional, and environmental materials produced by pharmaceutical companies.
• Evaluate and approve promotional content to ensure compliance with the French Public Health Code (CSP) and the recommendations of the French National Agency for Medicines and Health Products Safety (ANSM).
• Offer expert support for the preparation, submission, and follow-up of promotional materials requiring regulatory validation.

Requirements

About You:

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

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

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