Edwards Lifesciences yurak-qon tomir kasalliklarini davolash uchun bemorlarga yo‘naltirilgan tibbiy texnologiyalarni ishlab chiqadi. Kompaniya portfeliga kateter orqali o‘rnatiladigan yurak klapanlari, jarrohlik klapan yechimlari, mitral va uch tavaqali klapan terapiyalari, shuningdek gemodinamik, masofaviy va bashoratli monitoring uchun intensiv terapiya tizimlari kiradi. Kompaniya klinik tadqiqotlar ham olib boradi va yurak-qon tomir kasalliklari bilan yashayotgan insonlarning davolanish natijalarini yaxshilashga qaratilgan sog‘liqni saqlash innovatsiyalarini qo‘llab-quvvatlaydi. Ishga qabul qilish tibbiy texnologiyalar, klinik tadqiqotlar, muhandislik, intensiv terapiya va tegishli korporativ funksiyalarni qamrab olishi mumkin.
Senior Medical Writing Specialist — Remote in Mississippi
Lead medical writing activities for clinical evidence and regulatory submissions supporting Edwards Lifesciences’ transcatheter heart valve technologies. Manage literature reviews, complex deliverables, and collaboration across clinical, regulatory, and business teams.
Tavsif
- Prepare complex medical writing documents and deliverables, contributing to project-specific templates.
- Lead negotiations on deliverables and timelines while resolving issues with cross-functional stakeholders.
- Plan and conduct literature searches and reviews, maintain supporting documentation, and produce literature summaries.
- Represent the medical writing team in meetings covering reporting plans and regulatory submissions for clinical studies in the United States, European Union, and other international markets.
- Lead or support complex cross-functional work, including risk management reviews, instructions for use, and summary of safety and clinical performance documents.
- Guide, train, and mentor medical writers with less experience.
- Recommend and help implement ongoing improvements to medical writing processes.
- Serve as the main contact for medical writing projects and coordinate internal and external timelines with Edwards teams and clients.
Talablar
- Bachelor’s degree in a related field plus five years of medical writing experience, or equivalent work experience under Edwards’ criteria.
- Experience developing clinical evaluation reports under MEDDEV 2.7/1 Rev. 4 and/or the European Union Medical Device Regulation.
- Advanced proficiency with Microsoft Word, Excel, and PowerPoint.
- Experience using publication management software such as EndNote and research databases such as PubMed.
- Strong written and verbal communication, including customer negotiation and relationship management.
- Strong problem-solving, organizational, analytical, and critical-thinking abilities.
- Comprehensive understanding of the policies, procedures, and guidelines governing scientific content and medical writing.
- Demonstrated leadership and the ability to influence change.
- Exceptional attention to detail.
- Professional communication skills across all organizational levels.
- Ability to manage competing priorities in a fast-paced setting.
- Ability to collaborate within teams, including interdepartmental groups and project contacts representing the organization.
Imtiyozlar
- Competitive salary offerings.
- Performance-based incentive opportunities.
- A broad benefits portfolio designed to support the varying needs of employees and their families.