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Medical Writer Specialist
2 months ago
GxPeople Global is seeking a skilled Medical Writer to join our team on a permanent basis. This remote position offers the opportunity to work with a global medical device manufacturer, with some travel required throughout the year.
Key Responsibilities:- Collect, collate, and report on Post Market surveillance data to ensure compliance with regulatory requirements.
- Assist in designing and distributing questionnaires to collect post-market clinical follow-up data.
- Visit customers and trade shows to gather post-market clinical follow-up data.
- Upload approved documentation into the Quality Management System (QMS).
- Support the Regulatory Affairs team as needed.
- Identify opportunities for process improvements and implement changes to enhance clinical procedures.
- Scientific background (BSc or above in Biology, Chemistry, Biomedical Engineering, Life Science, or related field).
- Expertise in conducting focused literature searches on PubMed, MedLine, or other similar databases.
- Experience writing Post-Market Clinical Follow-up (PMCF) plans and reports to comply with EU MDR 745/2017 and MDCG guidelines.
- Understanding of how clinical activities support the QMS and product lifecycle.
- Excellent written and verbal communication skills.
- Effective communicator with the ability to convey messages logically and concisely.
- Ability to work to deadlines, be self-motivated, and well-organized.
- Ability to formulate reports and present findings.
- Attention to detail, systematic, and meticulous work orientation.
- Strong familiarity with Microsoft Office.
- Data mining and analysis skills.
- Ability to work cross-functionally to collect post-market clinical data.
Please contact us for more information about this opportunity.