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Clinical Specialist - Data Reviewer/Writer in Tucson, AZ at Apex Life Sciences

Date Posted: 12/7/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Tucson, AZ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    12/7/2018
  • Job ID:
    920197

Job Description


**For immediate consideration please send an updated copy of your resume to Megan Mantlo at mmantlo@apexlifesciences.com with 'Clinical Specialist Oro Valley, AZ' in the subject line**

Responsibilities:

  • Actively participates in implementation of strategy to address IVDR clinical evidence requirements across the product portfolio.
  • Conducts scientific literature reviews, objectively evaluates data, and prepares documentation (eg, scientific validity reports and clinical performance reports) for in vitro diagnostic products.
  • Demonstrates understanding of intended uses of IVDs and their application in clinical practice and applies this understanding to critical review of data and preparation of reports.
  • Ensures high quality documentation with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines.
  • Works with a cross-functional team (eg, Regulatory Affairs, Development, Medical Office, Quality, Marketing) to ensure timely completion and approval of clinical evidence documentation for Technical Files.
  • Interfaces with Regulatory Affairs and other groups within the company and other units of the company to stay informed about current performance evaluation requirements published or communicated by major HAs; including but not limited to IVDR guidance documents and implementing acts.
  • Miscellaneous duties and special projects as assigned, including deliverable tracking, process improvement, and literature review-based reports to support product registrations and marketing applications.
  • Tracks progress of assigned deliverables to ensure timelines and other project team needs are met.
  • Serves as a functional area subject matter expert for document management.

Qualifications:

  • Master’s degree in a biomedical or life sciences discipline
  • Minimum of 2 years scientific writing experience (e.g. manuscripts, book chapters, grants, clinical study protocols and/or reports)
  • Experience in study design and data analysis required
  • IVD product / cancer biology / oncology knowledge is highly desirable
  • Excellent written and verbal communication skills
  • Strong work ethic and demonstrated ability to deliver assignments on time
  • Application of scientific principles and concepts
  • Literature databases and search methods
  • Statistical basis for diagnostic device performance characteristics
  • Biomarker characterization, diagnostic testing laboratory workflow, histology, immunohistochemistry, and molecular biology

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




920197

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