Job Description

**Description** **Job Profile and Summary:** The Medical Writer is a member of the Global Medical Affairs and Post Market Surveillance team and is responsible for researching, creating, editing and coordinating the production of clinical documents; with a focus on Clinical Evaluation Reports required for CE marked medical devices and Post Market Surveillance documents required for both CE marked, and non-CE marked medical devices. The Medical Writer will plan and develop high quality clinical documents to support Cordis Medical devices. Primary responsibilities include preparing Clinical Evaluation Reports (CERs) and Plans (CEPs), Product Safety Update Reports (PSUR), Canadian Annual Summary Reports (CASR) and others as required by regulations. Additional responsibilities include providing input to product development and post-market sustaining core teams. The Medical Writer has medical writing and project management experience, a thorough understanding of research methodology and the ability to develop high-quality clinical documents. Extensive knowledge of the European medical device guidelines/regulations such as MEDDEV and MDD/MDR is required. The Medical Writer has the ability to lead cross-functional project teams. **Essential duties and responsibilities:** 1. Write Clinical Evaluation Reports (CERs) and post market surveillance summaries for CE marked devices 2. Work with internal teams to gain cross-functional inputs and approvals 3. Support periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives. 4. Develop and manage CER project plans and timelines. 5. Plan and deliver intra-departmental and cross-functional communication to ensure critical information is transmitted to relevant parties in a timely manner. 6. Perform periodic reviews of risk documentation, product labeling, and marketing claims as part of the clinical evaluation process. 7. Perform comprehensive literature searches to support assigned product lines. 8. Participate in audits 9. Consistently apply applicable global regulations and guidelines, as well as Cordis policies and procedures 10. Assist in development of processes 11. Provide clinical review/approval of labeling materials 12. Collect and maintain all documents necessary to ensure compliance with SOP 13. May support registration of products in non-EU countries **Essential qualifications:** **Technical skills:** 1. Minimum 3 years writing experience 2. Proven experience performing literature reviews, analyzing data and communicating outputs. 3. Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role. 4. Experience writing scientific documents for regulatory or journal submissions 5. Experience presenting scientific/clinical evidence in a written and oral manner to cross-functional teams. 6. Demonstrated ability to build positive constructive relationships with cross-functional team members 7. Extensive knowledge of MDD, MDR and MEDDEV requirements **Core skills:** 1. Excellent scientific writing skills 2. Experience creating and performing literature searches in Embase, PubMed and Google Scholar 3. Experience using Microsoft Word, Excel, PowerPoint. 4. Strong data extraction and analysis skills 5. Proactive with a sense of urgency in managing job responsibilities 6. Self-motivated and able to work independently. 7. Analytical thinking and inquisitive mindset 8. Ability and desire to develop good working relationships internally and externally **Education:** Bachelors in a relevant discipline required. Master's degree or PhD preferred \#LI-VC1 Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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