Recruit, onboard, train and manage talent for building organizational capabilities.
Manage deliverables (protocols, reports, literature searches, succinctly summarizing scientific content) and metrics with efficient planning, scheduling and resource allocations.
Author clinical trial protocols, interim and final clinical study reports, integrated safety/performance data summaries from raw data as applicable.
Perform formal literature searches, and succinctly summarize scientific content for assigned projects. Interprets literature information and synthesizes the information in clinical regulatory documents.
Provide clinical science subject matter expertise and consultation to clinical research associates, biostatistics, data management, regulatory affairs, medical Safety and other internal and external stakeholders.
Compiles clinical evidence from multiple sources such as current and past clinical trials, post market clinical follow up data and literature review updates, ad-hoc analysis, meta analyses, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesizes the information in support of EU- MDR submissions, required CERs, and annual updates.
Qualification & Experience
A minimum of a bachelor’s degree (BA or BS) in a technical and/or scientific discipline required.
Master’s or Ph.D. or other higher degree in health-related field (RN, BSN, BPharm/MD/MPH) is required
8+ years of Industry experience in medical technology or pharma is required
6+ years of experience in Scientific or Medical Writing, relevant academic or clinical research experience (Masters or PhD) is preferred.
Expertise in interpreting information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.