Clinical Scientist

🔥 18 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $160k - $170k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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Balt

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏭 Manufacturing

🏥 Healthcare

💰 Private Equity Round on 2015-09

Manufacturing • Healthcare

Balt is a leading company in the medical equipment manufacturing sector, specializing in innovative solutions for interventionnal neuroradiology. With over 45 years of experience, Balt collaborates closely with physicians to develop advanced neurovascular and peripheral vascular medical devices. The company has made significant contributions to the field, including the introduction of the first neurovascular intervention device in 1977 and now offers a comprehensive portfolio for treating both ischemic and hemorrhagic strokes, as well as peripheral embolization.

📋 Description

• Lead implementation of Clinical Evidence activities • Author clinical investigational plans and protocols for product approvals and expanded indications • Author Clinical Evidence reporting deliverables, including Clinical Study Reports, regulatory responses, and related documentation • Write literature reviews and summarize the state of the art for publications, study protocols, CSRs, and presentations • Analyze results for product applications and submissions • Collaborate with team members and stakeholders on Clinical Evidence projects and processes • Support clinical, regulatory, quality, and engineering deliverables • Maintain knowledge of assigned therapies and products and evaluate literature, clinical data, and medical references • Analyze data and prepare presentations for clinicians and cross-functional teams • Develop podium presentations and execute publication strategy • Lead publications for clinical study data, coordinating with investigator authors and reviewing abstracts and manuscripts • Serve on study teams and provide scientific support for trial design and scientific analysis • Analyze literature and competitive information across products and therapies • Support regulatory submissions and respond to regulatory-authority questions • Prepare data for meetings with the FDA • Perform other related duties and responsibilities • Report to the Director of Clinical Evidence

🎯 Requirements

• 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 • Minimum 2 years of medical writing experience writing CIPs and CSRs • Considerable experience interpreting scientific/clinical study information • Considerable experience writing clinical evidence-based documents and documents supporting regulatory submissions • Excellent communication skills • Comprehensive knowledge of the neurovascular field preferred • Ability to work well in a project team environment • Ability to work under pressure in a dynamic, timeline-driven environment • Demonstrated MS Office and Adobe Acrobat software skills

🏖️ Benefits

• Meaningful work contributing to improving patient lives • Close-knit, mission-driven team • Recognition of work • Respectful multicultural community • Employee care and support across countries • Equal Employment Opportunity employer

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