Spec Medical Affairs - #99955
Date: 04/19/2022 14:30 PM
City: Miami Lakes, Florida
Contract type: Part Time
Work schedule: Full Day
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. Additional responsibilities may be assigned.
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:
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 Cordis policies and procedures
- Assist in development of processes
- Provide clinical review/approval of labeling materials
- Collect and maintain all documents necessary to ensure compliance with SOP
May support registration of products in non-EU countries
- Bachelors or better in Science or related field
- Team Player: Works well as a member of a group
- Dedicated: Devoted to a task or purpose with loyalty or integrity
- Detail Oriented: Capable of carrying out a given task with all details necessary to get the task done well
- Goal Completion: Inspired to perform well by the completion of tasks
- Work-Life Balance: Inspired to perform well by having ample time to pursue work and interests outside of work
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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