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**About Balt**
Our purpose is to improve the lives of 150,000 patients in 2026.
**Our story**
Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries - and counting.
We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.
We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.
**Why Join Balt? Join a passionate team, dedicated to making a difference.**
- Working at Balt means giving meaning to your work Pride is a strong part of our identity.
- We are a close-knit team, with strong mission, vision and values that guide our day-to-day.
- Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.
- No matter the country, we take care of you.
Would you like to be part of our story? Don't hesitate, come and join us
**Description**:
As part of the Clinical Affairs team and reporting to the Clinical Science Manger,
You will have the following **job responsibilities**:
- Design clinical trials and studies in collaboration with internal stake holders including clinical operations, clinical science, biostatistics, data management, regulatory affairs, medical affairs as well as external stake holders including scientific committees, and national principal investigators (if applicable).
- Manage Scientific Committee related to assigned activities (e.g., protocol & publications writing) with development of agreements and presentation materials.
- Lead or support development of clinical investigational plans and protocols to comply with the overall clinical strategy and to support regulatory pre-marketing, post-marketing, market adoption and/or health economic initiatives across International.
- Lead the generation of study-related documents and/or contribute content and oversight of such documents, including, but not limited to, clinical study protocols, case report forms, statistical analysis plan, clinical study reports, and informed consent forms.
- Perform or coordinate the Data Review and cleaning activities in collaboration with the Clinical Project Managers.
- Critically analyze data and present to internal and external groups including but not limited to clinicians and cross-functional team members.
- Develop the scientific podium and publication strategy in close collaboration with cross-functional teams and lead the execution of the publication strategy.
- Lead publications for clinical study data through coordination with investigator authors and reviews/revises abstracts and manuscripts.
- Act as the scientific expert of the study team and provide scientific support to justify trial design, to perform adequate data review and ongoing scientific analysis during protocol and clinical study report development.
- Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area.
- Review and critically analyze statistical analysis plans.
- Lead study level publication planning
- Generate documents to support regulatory submissions for Balt products and/or respond to questions from regulatory authorities about existing submissions.
- Supports Global products and clinical strategy by ensuring compliance to ISO 14155, FDA CFR, ICH/GCP, MDD and EU MDR.
- Participate in cross-functional activities such as MDR remediation and design product development.
- Attend, present at, and possibly lead meetings with regulatory agencies as applicable.
- Follow company policies, procedures and standard operating procedures and participate to the set up and follow up of procedures related to the clinical science activities.
**Qualification Requirements**:
- Eight years in Clinical Research with a robust scientific background (PhD, PharmD or equivalent)
- Significant experience with clinical evidence-based regulatory submissions
- Significant experience interpreting scientific/clinical study information
- Fluent in English
- Experience in medical device and/or neuroradiology preferred
- Excellent communicating/negotiating skills with physicians
- Curious and responsive
Balt Group is an Equal Employment Opportunity employer.
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