- Franklin Lakes, New Jersey, US
- 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