Medical Writer, Clinical Evaluation Reports (Remote US Based)

Green Key Resources; United States; Remote; USD 70,000 - 100,000; Full time

Job summary

A leading company in medical equipment manufacturing is seeking a Medical Writer to support the development of clinical evaluation documents. The role involves writing Clinical Evaluation Plans and Reports, analyzing clinical evidence, and ensuring compliance with regulatory guidelines. Candidates should possess a BA/BS degree, strong writing skills, and at least 2 years of relevant experience in medical or scientific writing.

Qualifications

• Minimum of 2 years relevant experience.
• Knowledge of regulatory agency guidelines on clinical evaluation requirements.

Responsibilities

• Writing Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER).
• Conducting comprehensive literature searches and critically evaluating clinical evidence.
• Reviewing IFUs and Risk Management files.

Skills

Medical writing

Data analysis

Literature review

Communication

Education

BA/BS degree

MS preferred

Job description

Medical Writer, Clinical Evaluation Reports (Remote US Based)

The Clinical Evaluation Specialist supports the development of clinical evaluation documents (e.g., CEP, CER, PMCFP, PMCFR, and SSCP) throughout the product development and lifecycle. Experience in medical or scientific writing, critical literature review, data analysis, and/or quality engineering/risk management, along with strong written and verbal communication skills, are required. This role involves supporting a lead author by writing documents, reviewing literature, and other tasks under their guidance.

Responsibilities may include:

• Supporting the clinical evaluation process by writing Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post Market Clinical Follow Up Plans (PMCFP), Post Market Clinical Follow Up Reports (PMCFR), and Summary of Safety and Clinical Performance [SSCP] for medical devices.
• Identifying, evaluating, appraising, analyzing, summarizing, and synthesizing clinical evidence from sources such as preclinical studies, clinical investigations, literature, and post-market surveillance. Analyzing results for product applications and submissions.
• Conducting comprehensive literature searches, critically evaluating clinical evidence, reviewing and summarizing scientific literature, extracting data, interpreting results, synthesizing literature, and preparing formal reports.
• Reviewing IFUs, Risk Management files, and other cross-functional documents to ensure alignment of risk information.
• Having knowledge of regulatory agency guidelines on clinical evaluation requirements.
• Communicating timelines, required inputs, project risks, etc., clearly and promptly with cross-functional stakeholders.

Required Knowledge and Experience:

• BA/BS degree required; MS preferred.
• Minimum of 2 years relevant experience.

Seniority level

• Associate

Employment type

• Contract

Job function

• Writing/Editing and Design

Industries

• Medical Equipment Manufacturing, Pharmaceutical Manufacturing, Writing and Editing