[Remote] Clinical Scientist
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a rapidly growing pioneer in the medical device industry, committed to improving patient lives. The Clinical Scientist role involves leading clinical evidence activities, authoring clinical investigation protocols, and providing strategic leadership while collaborating with cross-functional teams to support clinical operations and regulatory submissions.
Responsibilities
- Leads implementation of Clinical Evidence activities
- Authors clinical investigational plans and protocols for product approvals and expanded indications consistent with reputed company’s needs and priorities
- Authors Clinical Evidence reporting deliverables, including Clinical Study Reports, regulatory responses, and other reputed company 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 reputed company reputed company and processes
- Supports additional clinical, regulatory, reputed company and engineering reputed company 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 reputed company reputed company including but not limited to clinicians and cross-functional team members
- Develops reputed company presentations and support publication reputed company in reputed company collaboration with Clinical Evidence Director and cross-functional teams and leads the execution of the publication reputed company
- reputed company publications for clinical study data through coordination with investigator authors, writes appropriate sections, and reviews/revises abstracts and manuscripts
- Serve as an reputed company member of study teams and reputed company 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 reputed company the assigned therapeutic area
- Support regulatory submissions for reputed company products and/or respond to questions from regulatory authorities about existing submissions
- Prepares data to be presented during meetings with FDA
- Performs other reputed company 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 reputed company in a project team environment
- Works reputed company under pressure in a dynamic, reputed company-driven environment
- Demonstrated MS Office and reputed company Acrobat software skills
- Comprehensive knowledge neurovascular field preferred
reputed company
Company H1B Sponsorship