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Senior Specialist, Medical Writing Job at Edwards Lifesciences Gruppe in Califor
Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need.In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes for patients with mitral and tricuspid heart valve disease. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address unmet clinical needs.Responsibilities Support the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT.Perform and maintain systematic literature searches, develop search terms and criteria, extract relevant clinical data, and write clear and concise summaries of the data to support the development of clinical evaluation reports and clinical study reports.Develop routine, sustaining medical writing documents and deliverables; propose approaches to developing moderately complex documents.Review and provide thoughtful feedback on moderately complex cross‑functional deliverables (e.g., clinical study data, risk‑management documents, IFUs, SSED) using clinical and technical knowledge.Serve as the primary contact, negotiating deliverables, timelines, and resolving project‑related issues with assistance and in collaboration with cross‑functional stakeholders.Assist in the implementation of continuous process improvements as it relates to medical writing.Perform other incidental duties as required.Required Qualifications Bachelor’s Degree in a related field with 5 years of related experience working in medical affairs, clinical affairs and/or clinical science or equivalent work experience based on Edwards criteria.Preferred Qualifications Advanced degree (Master’s, PhD, Pharm D).Experience with literature reviews and various publication databases including PubMed and Embase.Experience in authoring clinical evaluation reports.Familiarity with the cardiovascular therapeutic area—including structural heart interventions, coronary interventions, and heart failure—and the current treatment landscape.Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations.Familiarity with FDA PMA applications.Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and global (US FDA, EU MDR) regulations.Experience working in a cross‑functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel.Demonstrated ability to work independently, prioritize, and manage multiple tasks simultaneously.Excellent oral and written communication skills.Experience with maintaining current, in‑depth product knowledge including current developments, clinical literature review, and therapeutic and product operation knowledge.Advanced working knowledge of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat.Strong analytical, problem‑solving, and scientific writing skills.Strict attention to detail.Ability to interact professionally with all organizational levels.Ability to work in a team environment and represent the organization on specific projects.Ability to build productive internal/external working relationships.Benefits The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first. We offer competitive salaries, performance‑based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $106,000 to $149,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).#LI‑Remote Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.#J-18808-Ljbffr
