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52 minutes agoReport problemPenumbra, Inc. is a global healthcare company focused on developing innovative technologies to help patients worldwide. Specializing in the production of medical devices for neuro and vascular conditions, Penumbra offers products such as thrombectomy devices, embolization catheters, and MRI-compatible systems. The company is dedicated to advancing patient care with next-generation software solutions like Lightning Flash 2. 0, designed for the rapid removal of blood clots and treatment of pulmonary embolism. Penumbra is committed to improving outcomes for conditions like stroke, brain aneurysm, and heart attack, supported by clinical evidence and investor growth strategies.•Serving as a key link among essential functions, the Scientific Communications Medical Writer ensures the clear, precise, and accessible communication of critical information. •By interpreting clinical study results and collaborating with healthcare professionals (e.g., study investigators, physicians, and KOLs) and cross-functional teams within clinical research, regulatory affairs, research and development, and marketing, the medical writer will prepare journal manuscripts and conference materials (e.g., abstracts and presentations) to support product development and marketing efforts. •Additionally, the medical writer may contribute to tracking medical writing documents, developing templates, and providing training for new staff members. •Prepare high-quality abstracts and presentations for submission and presentation at conferences. •Engage in scientific writing and/or edit manuscripts for submission to peer-reviewed journals to achieve publication goals. •Ensure scientific communication deliverables are completed in a timely manner. •Evaluate data and translate information into succinct, scientific summaries. •Collaborate cross-functionally with clinical, marketing, and creative teams to ensure data dissemination goals and deadlines are met. •Work with clinical study management and statistics teams to create timelines for completing data dissemination plans related to clinical studies. •Develop and maintain strong relationships with academic institutions, physicians, KOLs, hospitals, and scientific societies/associations to facilitate scientific communication efforts. •Contribute to the preparation of clinical data for analysis and scientific writing. •Conduct literature searches for relevant disease states and maintain the clinical literature library. •Attend relevant medical and scientific conferences to synthesize and disseminate summaries. •Lead cross-functional project reviews and serve as a subject matter expert on clinical study teams to create timelines for completing medical writing documents. •Serve as a core team member on clinical study teams, leading cross-functional project reviews. •Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. * •Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. * •Ensure other members of the department follow the QMS, regulations, standards, and procedures. * •Perform other work-related duties as assigned. *Indicates an essential function of the role•Advanced degree (Master’s, PhD, or MD) with 2+ years of experience as a medical writer in the medical device, biotech, or pharmaceutical industry; or 5+ years of experience as a medical writer in clinical/scientific research, or an equivalent combination of education and experience. •Recent experience as a medical writer for cardiovascular clinical trials within the medical device, biotech, or pharmaceutical industry is highly desired. •The ideal candidate will demonstrate an assiduous approach in their work and throughout their portfolio, ensuring a high level of accuracy and meticulous attention to detail in all tasks. •A natural team player, equally comfortable working on their own, with excellent organizational skills and the ability to prioritize assignments while handling multiple projects simultaneously. •Proficiency with the Microsoft Office suite of tools is required. •Familiarity with laws, regulations, standards, and guidance governing the conduct of clinical studies a plus.•A collaborative teamwork environment where learning is constant, and performance is rewarded. •The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases. •A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).
Posted 12 days ago
Seeking a Senior Statistical Programmer with advanced SAS programming skills
Join a supportive team in a data-focused clinical research organization
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Lead and manage CSV activities for clinical systems
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Transform data into research-ready datasets
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Speeding life-changing medicines to market
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Lead planning and oversight of clinical studies
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Manage and govern global clinical projects.
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