Senior Specialist, Medical Writing

🔥 0 minutes ago

🎸 Mississippi – Remote

🎸 Mississippi – Remote

💵 $108k - $153k / year

⏰ Full Time

🟠 Senior

✏️ Content Writer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Edwards Lifesciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1958

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

Healthcare • Consulting • Food & Beverage

Edwards Lifesciences is a global leader in patient-focused medical innovations. The company specializes in heart valve disease solutions, offering products and services such as transcatheter heart valves and mitral and tricuspid technologies, as well as surgical heart valve solutions. Edwards Lifesciences also focuses on critical care technologies including hemodynamic monitoring, remote monitoring, and predictive monitoring. The company conducts clinical research and is committed to improving patient lives through innovative cardiovascular disease solutions, while being a responsible corporate citizen with an emphasis on global corporate giving.

📋 Description

• Develop complex medical writing documents/deliverables and provide input on templates for assigned projects • Serve as the lead for negotiating deliverables and timelines and resolving project-related issues with cross-functional stakeholders • Conduct literature searches and reviews, including developing search strategies, managing associated documentation, and preparing literature summaries • Represent the team in core meetings for reporting plans and regulatory submissions for clinical studies in the US, EU, and internationally • Lead and contribute to complex cross-functional deliverables, including risk management reviews, IFUs, and SSEDs • Provide leadership, training, guidance, and mentoring to less experienced medical writers • Identify, recommend, and assist with implementing continuous medical-writing process improvements • Act as primary contact for medical writing projects and coordinate internal and external deliverable timelines with Edwards departments and clients

🎯 Requirements

• Bachelor's Degree in related field with 5 years of previous related experience in medical writing or equivalent work experience based on Edwards criteria • Experience with clinical evaluation report (CER) development under MEDDEV 2.7/1 REV. 4 and/or the European Union Medical Device Regulation (EU MDR) • Proven expertise in Microsoft Office Suite, including Word, Excel and PowerPoint • Experience with publication library software (e.g., ENDNOTE) and database systems (e.g., PubMed) • Excellent written and verbal communication skills, including customer negotiating and relationship management skills • Excellent problem-solving, organizational, analytical, and critical thinking skills • Full knowledge and understanding of policies, procedures, and guidelines related to the development of scientific content and medical writing • Good leadership skills and ability to influence change • Strict attention to detail • Ability to interact professionally with all organizational levels • Ability to manage competing priorities in a fast-paced environment • Ability to work in a team environment, including inter-departmental teams and key contacts representing the organization on projects

🏖️ Benefits

• Competitive salaries • Performance-based incentives • A wide variety of benefits programs to address the diverse individual needs of employees and their families