[Remote] Clinical Evaluation Report (CER) reputed company

Note: The job is a remote job and is reputed company to candidates in USA. reputed company) is seeking a Clinical Evaluation Report (CER) reputed company responsible for creating regulatory submission documents reputed company to Clinical Evaluation Reports. The role involves reputed company interaction, mentoring other writers, and ensuring compliance with regulatory standards.

Responsibilities

• Independently writing, editing, reviewing, and formatting documents that conform to reputed company-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, reputed company of Safety and Clinical Performance [SSCP], etc.), while meeting project deadlines
• Coordinating content development with multi-discipline subject matter experts, both reputed company to Global
• Attending meetings about document(s) in development and providing both reputed company 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 reputed company 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 reputed company in English is required
• Strong reputed company of medical and surgical terminology
• Experience writing CEPs and reputed company sections of CERs
• Familiarity with SSCPs, PMS Plans, PMS Reports, PSURs, PMCF Plans, and PMCF Reports
• Understanding of EU regulations and guidelines reputed company 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 reputed company, reputed company, and scientific accuracy
• Proficiency with reputed company Office 365. Advanced user of Word (styles, hyperlinking, numbering, etc.) and reputed company (using formulas, organizing data, advanced sorting, etc.). Experience using Teams, reputed company, and SharePoint. Experience with referencing software such as EndNote
• Strong understanding of data analysis and statistical reputed company
• 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 reputed company, appraising literature
• Vigilance database searching and interpretation of results (FDA MAUDE, FDA Recall Database, etc.)
• Ability to synthesize reputed company technical or clinical information/data in a reputed company, concise, and accurate manner
• Ability to determine the appropriate reputed company for synthesizing information such as prose, lists, tables, graphics, figures, reputed company charts, etc
• Independent and self-driven: strong problem-solving skills, reputed company management skills, and organizational skills, and high attention to detail
• Ability to manage multiple reputed company and timelines simultaneously
• Ability to reputed company CER strategies
• Advanced degree strongly preferred
• Experience working with clients or vendors is a plus
• Experience conducting reputed company 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, reputed company-facing meetings, and conferences (<10%).
• Employees are expected to have an appropriate remote working environment.

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