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 join our dynamic and ambitious Pharmacovigilance and Safety team. Rooted in a long-standing tradition of excellence in pharmacovigilance, our department continues to evolve rapidly, offering a vivid, forward-thinking work environment that embraces innovation and growth 

We are seeking a Senior Safety Officer with a primary focus on the compilation, authoring, and review of aggregate periodic safety reports, including PSURs/PBRERs, DSURs, and ACOs. The role leads the coordination and development of high-quality safety reports including clinical safety evaluations, cumulative safety analyses, and benefit–risk assessments in line with global regulatory requirements. In addition to aggregate reporting and related medical writing activity, the position may support additional pharmacovigilance activities such as risk management, regulatory submissions, compliance oversight, SOPs, training, audits, and CAPA implementation.

Requirements

·       Education: Degree in Life Sciences (Pharmacy, Medicine, Biology, Chemistry); advanced degree (MSc, PhD) is a plus

·       Languages: Fluent in English; French proficiency preferred

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.

We are currently looking for a Medical Writer focused on Clinical Evaluation for Medical Devices to join our growing team. This position will provide you with the opportunity to work on exciting projects that contribute to the advancement of medical technologies.

Reporting to the Head of Clinical Evaluation & Medical Writing, your primary mission will be to develop and maintain clinical evaluation documentation for implantable medical devices (Class IIb and III).

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 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

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

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.

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

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