Clinical Scientist

BALT Group•Irvine, CA

14h•Remote

About The Position

Clinical Scientist with a strong background in clinical science and medical writing. 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.

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.
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

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.