Clinical Scientist

About the role

Balt is a pioneering company in the medical device industry, dedicated to improving the lives of 150,000 patients by 2026. With a rich history spanning 45 years, Balt has developed innovative medical devices used globally by physicians. Currently expanding into the peripheral vascular space, Balt empowers physicians to save lives through its commitment to excellence and innovation.

Job Responsibilities

• Leads implementation of Clinical Evidence activities.
• Authors clinical investigational plans and protocols for product approvals and expanded indications.
• Authors Clinical Evidence reporting deliverables, including Clinical Study Reports, regulatory responses, and other related documentation.
• Demonstrate strong medical writing skills, with a minimum of 2 years of experience in writing CIPs and CSRs in the medical device industry.
• Writes literature reviews and summarizes the state of the art for publications and relevant sections of study protocols and CSRs.
• Analyzes results in preparation for product applications and submissions.
• Collaborates with team members and stakeholders in planning for and supporting Clinical Evidence related projects and processes.
• Serves as a Clinical Science representative on multi-discipline teams and identifies and resolves problems that may be complex in nature.
• Applies clinical science principles and knowledge to guide cross-functional partners and demonstrates critical thinking and creativity in support of projects.
• Supports additional clinical, regulatory, quality and engineering related deliverables as assigned.
• Maintains thorough knowledge of therapy and assigned products.
• Identifies appropriate sources of relevant data, interprets, evaluates, and incorporates information from various sources including literature, clinical data, and medical references.
• Critically analyzes data and prepares presentations for internal and external groups including but not limited to clinicians and cross-functional team members.
• Develops podium presentations and supports publication strategy in close collaboration with Clinical Evidence Director and cross-functional teams and leads the execution of the publication strategy.
• Serve as an active member of study teams and provide scientific support to justify trial design and ongoing scientific analysis during protocol and clinical study report development.
• Supports regulatory submissions for Balt products and/or responds to questions from regulatory authorities about existing submissions.
• Prepares data to be presented during meetings with FDA.

Qualifications

• PhD, or Pharm.D preferred, other advanced Medical or Life Sciences degrees may be considered.
• Minimum 5 years’ experience in Medical Device Industry in designing and reporting on clinical studies, with a minimum of 2 years of medical writing experience in writing CIPs and CSRs.
• Considerable experience interpreting scientific/clinical study information.

Skills

• Considerable experience in writing clinical evidence-based documents and other documents supporting regulatory submissions.
• Excellent communication skills.
• Comprehensive knowledge of the neurovascular field preferred.
• Ability to work well in a project team environment.
• Works well under pressure in a dynamic, timeline-driven environment.
• Demonstrated MS Office and Adobe Acrobat software skills.