Location: Zaventem, Belgium
Contract: 12 months with possible extension (Start from March-April 2026)
Kelly FSP is seeking a Clinical Submission Specialist to support one of the world's top five pharmaceutical companies in the medical devices sector. This role involves coordinating and preparing regulatory submissions to ensure compliance with global regulatory requirements for medical devices.
Key Responsibilities:
- Prepare and submit documents for EC/CA in the assigned region.
- Initiate and review translations of documents (e.g., Patient Informed Consent).
- Adapt Country/Site Specific Patient Informed Consent forms according to regulatory and EC requirements and obtain internal approval.
- Interpret clinical study protocols for EC/CA submission using layman terms where necessary.
- Act as the primary point of contact for EC/CA.
- Support document adaption per EC/CA requirements and manage responses.
- Assist in budget adaptation to meet country and site requirements.
- Maintain local regulatory documents and ensure they are uploaded to data management systems where applicable.
- Provide support to CSL and Clinical Project Teams.
- Assist in developing and reviewing informed consent documents to ensure all required elements are included.
- Support site activation document collection and approval processes.
- Attend, schedule, and document project-related meetings.
- De-identify and file adverse event source documents if applicable.
- Maintain the Clinical email box and disseminate emails appropriately.
- Support team personnel with site activation and closure activities.
Qualifications:
- 3-7 years of clinical submission experience across multiple EMEA regions.
- Must be familiar with submission processes across EMEA countries (Southern Africa, Israel, Eastern Europe are a plus).
- Effective phone communication skills are essential; candidates must be comfortable managing calls with authorities.
- Proficiency in English is required.
- Familiarity with cardiac, vascular, and/or neuromodulation technologies and clinical research processes is beneficial.
- Strong verbal, written communication, and interpersonal skills.
- Ability to work in a fast-paced, changing environment and within a geographically diverse business model.
- Strong organizational skills and ability to prioritize tasks to meet deadlines.
