Customs Specialist responsible for classifying imported goods and processing transactions. Collaborating with clients to ensure compliance with Customs regulations in logistics.
About the role
- Senior Specialist in Medical Writing developing regulatory and clinical documents for cardiac therapies at Edwards Lifesciences. Collaborating with cross-functional teams and driving evidence to optimize patient outcomes.
Responsibilities
- Support the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT.
- Perform and maintain systematic literature searches, developing search terms and criteria, extracting relevant clinical data, and writing 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/deliverables; propose approaches to developing moderately complex documents/deliverables.
- 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, in collaboration with cross-functional stakeholders.
- Assist in the implementation of continuous process improvements as it relates to medical writing.
- Other incidental duties.
Requirements
- Bachelor's Degree in a related field with 5 years of related experience working in medical affairs, clinical affairs and/or clinical science
- Preferred Hybrid On Site in Irvine, Ca
- Advanced degree (Master’s, PHD, Pharm D)
- Experienced with literature reviews and various publication databases including PubMed and Embase.
- Familiarity with the cardiovascular therapeutic area—including, but not limited to, structural heart interventions, coronary interventions, heart failure—and current treatment landscape; familiarity with clinical research and/or clinical trial experience.
- 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.
Benefits
- Competitive salaries
- Performance-based incentives
- A wide variety of benefits programs to address diverse individual needs
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