Note: The job is a remote job and is open to candidates in USA. Global Regulatory Writing & Consulting (GLOBAL) is seeking a Clinical Evaluation Report (CER) Writer responsible for creating regulatory submission documents related to Clinical Evaluation Reports. The role involves client interaction, mentoring other writers, and ensuring compliance with regulatory standards.
Responsibilities
- Independently writing, editing, reviewing, and formatting documents that conform to client-based regulatory submission guidelines and internal document standards (CERs, Clinical Evaluation Protocols [CEP], Post-market Surveillance [PMS] Plans, Post-market Clinical Follow-up [PMCF] Plans, Summary of Safety and Clinical Performance [SSCP], etc.), while meeting project deadlines
- Coordinating content development with multi-discipline subject matter experts, both internal and external to Global
- Attending meetings about document(s) in development and providing both internal and external management, team, and reviewers with timelines and document status reports as needed
- Providing mentoring and training for CER Writers
- Collaborating with other writers to ensure continuous improvements in writing style, harmonization of terminology, and team initiatives
Skills
- Minimum of a BA or BS in science, engineering, or medical field
- 1-5 years of medical writing experience in the medical device industry or medical writing
- Oral and written fluency in English is required
- Strong command of medical and surgical terminology
- Experience writing CEPs and all sections of CERs
- Familiarity with SSCPs, PMS Plans, PMS Reports, PSURs, PMCF Plans, and PMCF Reports
- Understanding of EU regulations and guidelines related to medical devices including: MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev. 4; and MDR 2017/745
- Comfort working in a regulated industry that demands conformance with regulatory requirements and a high level of quality, integrity, and scientific accuracy
- Proficiency with Microsoft Office 365. Advanced user of Word (styles, hyperlinking, numbering, etc.) and Excel (using formulas, organizing data, advanced sorting, etc.). Experience using Teams, Outlook, and SharePoint. Experience with referencing software such as EndNote
- Strong understanding of data analysis and statistical methods
- Ability to plan and execute systematic literature reviews (state of the art and device-specific): preparing search queries, selecting appropriate search databases and conducting the searches, creating and applying systematic inclusion/exclusion criteria, appraising literature
- Vigilance database searching and interpretation of results (FDA MAUDE, FDA Recall Database, etc.)
- Ability to synthesize complex technical or clinical information/data in a clear, concise, and accurate manner
- Ability to determine the appropriate medium for synthesizing information such as prose, lists, tables, graphics, figures, flow charts, etc
- Independent and self-driven: strong problem-solving skills, timeline management skills, and organizational skills, and high attention to detail
- Ability to manage multiple projects and timelines simultaneously
- Ability to develop CER strategies
- Advanced degree strongly preferred
- Experience working with clients or vendors is a plus
- Experience conducting quality reviews of CEPs and CERs is a plus
- Experience with literature management tools such as QUOSA or Distiller is a plus
Benefits
- Position is fully remote.
- Occasional travel for team retreats, client-facing meetings, and conferences (<10%).
- Employees are expected to have an appropriate remote working environment.
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