Clinical Scientist

Balt USA; Irvine (CA); On-site; USD 160,000 - 170,000; Full time

Job summary

Balt Group is seeking a Clinical Scientist – Medical Writer to support clinical evidence and regulatory submissions. You will author and review CIP/CSR documents, prepare publications, and guide strategies with cross-functional teams.

The role requires strong clinical science expertise, with experience in medical writing and regulatory interactions. A PhD or PharmD is preferred; MS Office and publication tools are essential.

Qualifications

• Proven experience writing CIP and CSR in medical devices.
• Strong ability to interpret scientific/clinical data.
• Excellent communication within cross-functional teams.

Responsibilities

• Lead implementation of Clinical Evidence activities.
• Author CIP and CSR documents for product approvals.
• Prepare Clinical Study Reports and regulatory responses.
• Develop publications strategy with Clinical Evidence Director.
• Support regulatory submissions and FDA interactions.
• Collaborate with cross-functional teams on study design and analysis.

Skills

Medical writing

Regulatory submissions

Clinical data interpretation

Scientific communication

Team collaboration

Education

PhD or PharmD preferred

Tools

MS Office

Adobe Acrobat

Job description

About Balt

Our purpose is to improve the lives of 150,000 patients in 2026.

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

About this opportunity – Clinical Scientist

The Clinical Scientist – Medical Writer has a strong background in clinical science and experience in clinical evidence and clinical operations, with track record of writing clinical investigation protocols (CIPs) and clinical study reports (CSRs). The Clinical Evidence organization supports R&D, designs and analyzes clinical trials (from FIM to Pivotal trials; post-market-research, US or International) and supports the needs of clinical operations (protocol development, clinical study report development). This position authors and reviews documents, including manuscripts and clinical study reports and provides strategic leadership to the department. The individual 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. This position will have significant interaction with internal stakeholders and will report to the Director of Clinical Evidence.

Job Responsibilities

• Leads implementation of Clinical Evidence activities.
• Authors clinical investigational plans and protocols for product approvals and expanded indications consistent with the company’s needs and priorities.
• Authors Clinical Evidence reporting deliverables, including Clinical Study Reports, regulatory responses, and other related documentation
• Demonstrate strong medical writing skills, with a minimum experience of 2 years of writing CIPs, CSRs in medical device industry.
• Writes literature reviews and summarizes state of the art for publications and relevant sections of study protocols and CSRs, and presentations to internal/external stakeholders, as needed.
• 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.
• Supports additional clinical, regulatory, quality and engineering related deliverable 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 support publication strategy in close collaboration with Clinical Evidence Director and cross-functional teams and leads the execution of the publication strategy.
• Lead publications for clinical study data through coordination with investigator authors, writes appropriate sections, and reviews/revises abstracts and manuscripts.
• 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.
• Analyzes literature and competitive information across products and therapies within the assigned therapeutic area.
• Support regulatory submissions for Balt products and/or respond to questions from regulatory authorities about existing submissions.
• Prepares data to be presented during meetings with FDA.
• Performs other related duties and responsibilities.

Qualification 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 l 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 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

The above information on this description have been designed to indicate the general nature of work performed by employees within this position. It is not a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

Balt Group is an Equal Employment Opportunity employer.

Pay Range: $160,000 USD - $170,000 USD