Medical Writer (19-00271) – CA – Irvine

The Medical Writer supports the Global Neurovascular business unit. This Writer will develop clinical, scientific, and regulatory documents while working in a cross-functional team in accordance with the highest quality standards.
Lead the development and completion of Clinical Evaluation Reports (CERs) as part of
design validation for new medical devices to support product registrations internationally,
maintain periodic updates, perform gap analysis, and revise existing CERs
  • Collaborate with the Quality organization and perform Clinical Risk Benefit Analysis
  • (CRBAs) to support risk management activities
  • Work in a cross-functional team and draft clinical study reports (CSRs); provide support
  • with submissions to regulatory agencies by drafting clinical sections of global
  • submissions (eg, IDE, PMA)
  •  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 stake holders
  • ¿ 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
  •  May attend major national & international conferences to keep up to date with
  • advancements in the field; contribute to the development of conference coverage reports
  • for internal distribution
  • Develop and maintain SOPs and writing tools, such as templates and style manuals
  • Experience in the development of clinical, scientific, and regulatory documents
  • Basic understanding of Medical Writing, including familiarity with writing styles such as
  • American Medical Association
  • Demonstrated ability to meet project goals within a matrix environment; excellent project
  • management and organizational skills
  • Understanding of global regulatory agencies and regulatory processes concerning
  • medical devices
  • 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 a keen attention to detail
  • Strong verbal, written, and interpersonal communication skills
  • Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint) and
  • EndNote
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with
  • attention to detail; ability to work in a fast-paced environment
  • Expertise in conducting focused literature searches on PubMed, MedLine or other similar
  • medical literature databases
REQUIRED EDUCATION: Advanced degree in a scientific discipline (Ph.D., MD, or Pharm. D.)
preferably with 1+ years' experience in the medical device/pharmaceutical field

Source: Job Diva – Job Listing

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