Medical Writer
New
Based in the United StatesFull-TimeMiddle
Salary105,000 - 115,000 USD per year
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Job Details
- Experience
- Minimum of 3 years of medical writing experience.
- Required Skills
- Microsoft Office
Requirements
- Bachelor’s degree in a relevant scientific discipline or equivalent.
- Minimum of 3 years of medical writing experience.
- Strong understanding of clinical affairs regulations (EU MDR 2017/745, MEDDEV, MDCG, ISO standards, ICH).
- Experience conducting literature reviews using PubMed, Embase, or similar.
- Exceptional written and verbal communication skills.
- Strong analytical, organizational, and problem-solving skills.
- Excellent project management abilities to meet deadlines.
- Ability to work independently and within cross-functional teams.
- Advanced proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint).
- Flexibility for project-based travel if required.
Responsibilities
- Lead and contribute to the development of Clinical Evaluation Reports (CERs) and related clinical documentation.
- Support Post-Market Clinical Follow-up (PMCF) activities through data and literature assessments.
- Conduct comprehensive and systematic literature searches using research databases.
- Analyze clinical evidence to support clinical development strategies.
- Write, edit, and review clinical study documentation including protocols and study reports.
- Ensure documentation meets regulatory expectations for submission.
- Develop scientific manuscripts, abstracts, and conference submissions.
- Collaborate with medical professionals to ensure data integrity and publication alignment.
- Contribute to the optimization of clinical affairs procedures and practices.
- Partner with internal teams and external stakeholders, including clinical vendors.
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