Remote Medical Writer - Neurovascular
5290 California Avenue Irvine, CA 92617 US
In this exciting role as a Medical Writer in the Clinical Sciences, Strategy, and Communications group of the Neurovascular Operating Unit, you will have primary responsibility for leading and developing clinical, scientific, and regulatory documents while working in a cross-functional team in accordance with the highest quality standards. This is a dynamic opportunity where you will also be involved in global clinical development activities and clinical strategy. 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.
Responsibilities may include the following and other duties may be assigned.
- Complete Clinical Evaluation Plans/Reports (CEPs/CERs), and PMCF plans and Summary of Safety and Clinical Performance (SSCPs) as for new and existing medical devices.
- Work in a cross-functional team and draft investigator brochures (IBs) and Annual Progress Reports
- 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 document 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 complaint handling unit, as required
- Excellent writing and editing skills, and a keen attention to detail
- Excellent project management and organizational skills
- Ability to lead multiple large, complex projects to completion with independence under limited supervision
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail; ability to work in a fast-paced environment
- 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
- Strong verbal, written, and interpersonal communication skills
- Ability to provide guidance, coaching, and training to other writers
- Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint) and EndNote
- Expertise in conducting focused literature searches on PubMed, MedLine, or other similar medical literature databases
Must Have (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume.
- Advanced degree (MD or PhD preferred) and a minimum of 0 years medical writing experience
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