Senior Specialist, Medical Writing

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $108k - $153k / year

⏰ Full Time

🟠 Senior

✏️ Content Writer

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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 and deliverables and provide input on templates for assigned projects • Lead negotiation of deliverables and timelines and resolve project-related issues with cross-functional stakeholders • Conduct literature searches and reviews, develop search strategies, manage associated documentation, and prepare literature summaries • Represent the medical writing function in core team meetings for reporting plans and regulatory submissions for clinical studies • Lead and contribute to complex cross-functional deliverables, including risk management reviews, IFUs, and SSEDs • Provide leadership, training, guidance, and mentorship to less experienced medical writers • Identify, recommend, and assist with implementing continuous medical-writing process improvements

🎯 Requirements

• Bachelor's Degree in a related field with 5 years of previous related experience in medical writing, or equivalent work experience based on Edwards criteria • Graduate degree in life science, engineering, or a related field preferred • Experience with clinical evaluation report development under MEDDEV 2.7/1 REV. 4 and/or EU MDR preferred • Proven expertise in Microsoft Office Suite, including Word, Excel, and PowerPoint • Experience with publication library software such as ENDNOTE and database systems such as PubMed • Excellent written and verbal communication skills, including customer negotiation and relationship management skills • Excellent problem-solving, organizational, analytical, and critical thinking skills • Full knowledge and understanding of policies, procedures, and guidelines related to 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 organizational contacts on projects

🏖️ Benefits

• Competitive salaries • Performance-based incentives • Wide variety of benefits programs addressing employees' and their families' diverse individual needs