Clinical Scientist

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee the execution of Clinical Evidence initiatives.

• Create clinical investigational plans and protocols for product approvals and expanded indications.

• Prepare Clinical Evidence reporting deliverables, including Clinical Study Reports, regulatory responses, and associated documentation.

• Conduct literature reviews and summarize the current state of knowledge for publications, study protocols, CSRs, and presentations.

• Evaluate results for product applications and submissions.

• Collaborate with team members and stakeholders on Clinical Evidence projects and processes.

• Provide support for clinical, regulatory, quality, and engineering deliverables.

• Stay informed on assigned therapies and products while reviewing literature, clinical data, and medical references.

• Analyze data and create presentations for clinicians and cross-functional teams.

• Develop podium presentations and implement publication strategies.

• Lead publication efforts for clinical study data, coordinating with investigator authors and reviewing abstracts and manuscripts.

• Participate on study teams and offer scientific support for trial design and analysis.

• Review literature and competitive information across various products and therapies.

• Assist with regulatory submissions and address inquiries from regulatory authorities.

• Prepare data for discussions with the FDA.

• Execute other related duties and responsibilities as needed.

• Report directly to the Director of Clinical Evidence.

⛳️ Requirements

• PhD or Pharm.D preferred; other advanced Medical or Life Sciences degrees may also be considered.

• At least 5 years of experience in the Medical Device Industry focused on designing and reporting clinical studies.

• Minimum of 2 years of medical writing experience, specifically in writing CIPs and CSRs.

• Significant experience in interpreting scientific and clinical study data.

• Extensive experience in producing clinical evidence-based documents and documentation for regulatory submissions.

• Exceptional communication skills.

• Comprehensive knowledge of the neurovascular field is preferred.

• Proven ability to excel in a project team environment.

• Capability to perform well under pressure in a fast-paced, deadline-driven setting.

• Demonstrated proficiency in MS Office and Adobe Acrobat software.

🏝️ Benefits

• Engaging work that contributes to enhancing patient lives.

• A close-knit, mission-driven team.

• Recognition for your contributions.

• A respectful multicultural community.

• Employee support and care across various countries.

• An Equal Employment Opportunity employer.