Clinical Evaluation Report Writer

This is a fully remote position, open to applicants in United States.

📋 Description

• Write, edit, review, and format regulatory submission documents independently, including CERs, CEPs, PMS Plans, PMCF Plans, and SSCPs.

• Adhere to project deadlines while following client regulatory submission guidelines and internal document standards.

• Collaborate with internal and external multidisciplinary subject matter experts to coordinate content development.

• Participate in document-development meetings, providing timelines and reports on document status.

• Mentor and train CER Writers.

• Work alongside other writers to enhance writing style, harmonize terminology, and promote team initiatives.

• Formulate CER strategies.

• Conduct systematic literature reviews, perform vigilance database searches, and interpret results.

• Integrate complex technical and clinical information using various formats, including prose, tables, graphics, figures, and flow charts.

• Oversee multiple projects and timelines concurrently.

• Engage with clients and vendors as necessary.

⛳️ Requirements

• A minimum of a BA or BS in a science, engineering, or medical field; an advanced degree is highly desirable.

• 1–5 years of experience in medical writing within the medical device industry or relevant medical writing experience.

• Required fluency in both oral and written English.

• Strong knowledge of medical and surgical terminology.

• Experience in writing CEPs and all sections of CERs.

• Familiarity with SSCPs, PMS Plans, PMS Reports, PSURs, PMCF Plans, and PMCF Reports.

• Understanding of EU medical-device regulations and guidelines, including MDD 93/42/EEC, AIMDD 90/385/EEC, MEDDEV 2.7/1 Rev. 4, and MDR 2017/745.

• Previous experience in a regulated industry with high standards for quality, integrity, and scientific accuracy.

• Proficient in Microsoft Office 365, particularly advanced Word and Excel skills.

• Familiarity with Teams, Outlook, SharePoint, and referencing software such as EndNote.

• Strong grasp of data analysis and statistical methods.

• Capability to plan and conduct systematic literature reviews.

• Experience with literature management tools like QUOSA or Distiller is a bonus.

• Competence in vigilance database searching and interpretation, including FDA MAUDE and FDA Recall Database.

• Ability to clearly, concisely, and accurately synthesize complex technical or clinical information.

• Excellent problem-solving, timeline management, organizational, and attention-to-detail skills.

• Ability to manage multiple projects and timelines simultaneously.

• Ability to develop CER strategies.

🏝️ Benefits

• Fully remote position.

• Occasional travel for team retreats, client-facing meetings, and conferences (<10%).