Note: The job is a remote job and is open to candidates in USA. Balt is a rapidly growing medical device company pioneering neurovascular and peripheral vascular innovations to improve patient lives. The Clinical Scientist – Medical Writer leads clinical evidence activities, authors clinical investigation protocols and study reports, analyzes clinical data and literature, and supports regulatory submissions and publication strategies. The role collaborates with cross-functional teams and provides scientific leadership for clinical studies and evidence development.
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
Skills
- 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
- Considerable experience in writing clinical evidence-based documents and other documents supporting regulatory submissions
- Excellent communication skills
- 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
- Comprehensive knowledge neurovascular field preferred
Company Overview
Company H1B Sponsorship