Medical Writer
New
G
GetingeMedical Devices
United States, ESTContractMiddle
Salary105,000 - 115,000 USD per year
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Job Details
- Experience
- Minimum of 3 years medical writing experience
- Required Skills
- Project ManagementMicrosoft Office
Requirements
- Bachelor's degree in a relevant scientific discipline, or equivalent combination of education and experience.
- Minimum of 3 years of medical writing experience.
- High level of attention to detail and ability to own and drive accuracy.
- Strong interpersonal, communication, and project management skills.
- Proficiency in using and navigating PubMed, Embase, and other literature search engines.
- Strong working knowledge of EU MDR (2017/745), EU MDD (93/42/EEC), and MEDDEV guidance.
- Familiarity with ISO 14155, ISO 13485, ISO 14971, and ICH guidance (E3 CSR, E6 R3 GCP).
- Advanced skills in Microsoft Office (Outlook, Word, Excel, PowerPoint).
- Demonstrated ability to work independently and as part of a team.
- Ability to prioritize tasks under urgent deadlines in a fast-paced environment.
Responsibilities
- Serve as a clinical evaluation lead to develop Clinical Evaluation Reports (CER) and associated documentation.
- Participate in the Post-Market Clinical Follow-up (PMCF) team for evaluation and analysis.
- Perform comprehensive systematic, documented literature reviews to support Clinical Evaluation and protocol development.
- Analyze clinical evidence to assist with clinical development strategy.
- Write and edit clinical study documentation such as protocols, Investigator's Brochures, and Clinical Study Reports.
- Act as a subject matter expert on clinical aspects of technical documentation.
- Develop manuscripts for peer-reviewed journals and abstracts for medical congresses in collaboration with medical professionals.
- Contribute to the development and optimization of Clinical Affairs SOPs.
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