[Remote] Clinical Scientist

Note: The job is a remote job and is open to candidates in USA. Balt 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.ResponsibilitiesLeads implementation of Clinical Evidence activitiesAuthors clinical investigational plans and protocols for product approvals and expanded indications consistent with the company’s needs and prioritiesAuthors Clinical Evidence reporting deliverables, including Clinical Study Reports, regulatory responses, and other related documentationDemonstrate strong medical writing skills, with a minimum experience of 2 years of writing CIPs, CSRs in medical device industryWrites 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 neededAnalyzes results in preparation for product applications and submissionsCollaborates with team members and stakeholders in planning for and supporting Clinical Evidence related projects and processesSupports additional clinical, regulatory, quality and engineering related deliverable as assignedMaintains 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 referencesCritically analyzes data and prepares presentations for internal and external groups including but not limited to clinicians and cross-functional team membersDevelops podium presentations and support publication strategy in close collaboration with Clinical Evidence Director and cross-functional teams and leads the execution of the publication strategyLead publications for clinical study data through coordination with investigator authors, writes appropriate sections, and reviews/revises abstracts and manuscriptsServe 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 developmentAnalyzes literature and competitive information across products and therapies within the assigned therapeutic areaSupport regulatory submissions for Balt products and/or respond to questions from regulatory authorities about existing submissionsPrepares data to be presented during meetings with FDAPerforms other related duties and responsibilitiesSkillsPhD, or Pharm.D preferred, other advanced Medical or Life Sciences degrees may be consideredMinimum 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 CSRsConsiderable experience interpreting scientific/clinical study informationConsiderable experience in writing clinical evidence-based documents and other documents supporting regulatory submissionsExcellent communication skillsAbility to work well in a project team environmentWorks well under pressure in a dynamic, timeline-driven environmentDemonstrated MS Office and Adobe Acrobat software skillsComprehensive knowledge neurovascular field preferredCompany OverviewBalt is specialist manufacturer of 'Interventional Neuro Radiology’ (‘INR’) devices used to treat strokes and aneurysms It was founded in 1977, and is headquartered in Montmorency, Ile-de-France, FRA, with a workforce of 501-1000 employees. Its website is http://www.balt.fr/.Company H1B SponsorshipBalt has a track record of offering H1B sponsorships, with 1 in 2024, 1 in 2023. Please note that this does not guarantee sponsorship for this specific role.