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Medical Writer


R esponsibilities:

  • Write clinical evaluation reports (CERs) and post market surveillance summaries for CE marked devices
  • Work with internal teams to gain cross-functional inputs and approvals
  • Support periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives.
  • Develop and manage CER project plans and timelines.
  • Plan and deliver intra-departmental and cross-functional communication to ensure critical information is transmitted to relevant parties in a timely manner.
  • Perform periodic reviews of risk documentation, product labeling, and marketing claims as part of the clinical evaluation process.
  • Perform comprehensive literature searches to support assigned product lines.
  • Participate in audits
  • Consistently apply applicable global regulations and guidelines, as well as Cardinal Health policies and procedures
  • Assist in development of processes
  • Provide clinical review/approval of marketing materials
  • Maintain and update spreadsheets tracking the status for CER projects
  • Collect and maintain all documents necessary to ensure compliance with SOP
  • May manage contract writers
  • May support registration of products in non-EU countries
  • Minimum 3 years writing experience
  • Proven experience performing literature reviews, analyzing data and communicating outputs.
  • Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.
  • Experience writing scientific documents for regulatory or journal submissions
  • Experience presenting scientific/clinical evidence in a written and oral manner to cross-functional teams.
  • Demonstrated ability to build positive constructive relationships with cross-functional team members
  • Demonstrated high level of personal integrity, emotional intelligence, flexibility
  • Extensive knowledge of MDD, MDR and MEDDEV requirements
  • Excellent scientific writing skills
  • Experience creating and performing literature searches in Embase, PubMed and Google Scholar
  • Experience using Microsoft Word, Excel, PowerPoint.
  • Strong data extraction and analysis skills
  • Proactive with a sense of urgency in managing job responsibilities
  • Self-motivated and able to work independently.
  • Analytical thinking and inquisitive mindset
  • Ability and desire to develop good working relationships internally and externally
  • 8 hour shift
  • GCP: 1 year (Preferred)
  • Managed care: 1 year (Preferred)
  • Writing skills: 1 year (Preferred)

Work Location: Remote

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