Overview Why consider this job opportunity :
Salary up to $149,000 for highly experienced candidates
Opportunity for career advancement and growth within the organization
Supportive and collaborative work environment
Chance to make a positive impact on patient outcomes through innovative medical technologies
Work in a dynamic field focused on addressing unmet clinical needs in cardiovascular health
Competitive salaries and performance-based incentives, along with a wide variety of benefits
Responsibilities Support the development of regulatory and clinical documents for a portfolio of products in Transcatheter Mitral and Tricuspid Therapies (TMTT)
Conduct systematic literature searches, extract relevant clinical data, and write summaries to support clinical evaluation and study reports
Develop and propose approaches for moderately complex medical writing documents and deliverables
Review cross-functional deliverables and provide feedback using clinical and technical knowledge
Serve as the primary contact for negotiating deliverables and resolving project-related issues in collaboration with stakeholders
Qualifications Bachelor\'s Degree in a related field with 5 years of experience in medical affairs, clinical affairs, and / or clinical science
Strong oral and written communication skills
Ability to work independently and manage multiple tasks simultaneously
Advanced knowledge of scientific research methodology, device development processes, and relevant regulations
Proficiency in MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat
Preferred Qualifications Advanced degree (Master’s or higher) in a related field
Experience with literature reviews and publication databases such as PubMed and Embase
Familiarity with the cardiovascular therapeutic area and clinical research
Knowledge of MEDDEV 2.7 / 1 and EU MDR for clinical evaluations
Experience in a cross-functional, collaborative environment
#MedicalDevices #ClinicalScience #HealthcareCareers #PatientOutcomes #CareerGrowth
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Senior Specialist At • Baltimore, MD, United States