Senior Medical Writer

• Posted : 2 years ago

In this exciting role as a Senior Medical Writer for the Neurovascular Operating Unit, you will have primary responsibility for developing clinical, scientific, and regulatory documents while working in a cross-functional team in accordance with the highest quality standards. The Neurovascular Operating Unit provides a comprehensive portfolio of proven, powerful neurovascular technologies, setting the highest standards of integrity and reliability in Acute Ischemic and Hemorrhagic Stroke Care.

Location: open to remote within the United States

What You'll Do:

• Lead the development and completion of Clinical Evaluation Plans/Reports (CEPs/CERs) as part of design validation for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CEPs/CERs
• Work in a cross-functional team and draft clinical investigation plans (CIPs), clinical study reports (CSRs), investigator brochures (IBs), and Annual Progress Reports
• Provide support with submissions to regulatory agencies by drafting clinical sections of global submissions (eg, IDE, PMA)
• Collaborate with the Quality organization and perform Clinical Risk-Benefit Analysis (CRBAs) to support risk management activities
• Conduct scientific literature reviews and compile reports such as annual literature updates and periodic safety updates to global regulatory agencies
• Collaborate with Regulatory Affairs and provide support to respond to questions from regulatory agencies
• For all documents, coordinate and manage the review process, lead discussions on document revision, revise documents per comments from external and internal reviewers, and ensure timely approvals from all reviewers
• Conduct literature searches and clinical evidence mapping, manage the literature database, and prepare literature reviews for external and internal stakeholders
• Participate in the periodic reviews of recent scientific publications and online content relevant to the business; draft article summaries for distribution to key stakeholders
• Contribute to post-market surveillance activities by keeping abreast of newly published scientific literature on assigned devices and report to the complaint handling unit, as required

What You'll Need:

• Bachelor’s degree and a minimum of 4 years medical writing experience or advanced degree and a minimum of 2 years medical writing experience
• Advanced degree (PhD, PharmD, MD)
• Experience in the preparation of Clinical Evaluation Reports (CERs) is strongly preferred
• Proficiency with European Union Medical Device Regulations (EU MDR) and guidance
• Basic understanding of Medical Writing, including familiarity with writing styles such as American Medical Association
• Excellent project management and organizational skills
• Ability to understand and interpret results of published literature and clinical studies; working knowledge of statistics is required
• Ability to summarize complex results and present in a clear, concise, and scientifically accurate manner to a wide range of audiences
• Excellent writing and editing skills, and keen attention to detail
• Expertise in conducting focused literature searches on PubMed, MedLine, or other similar medical literature databases

Skills

• publishing
• editing