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Improving R&D of first-in-human drug candidates in pharma. Supercharging clinical trials. Elevating the quality of care.
Medical Writer – Clinical Specialist
Location
United Kingdom
Posted
79 days ago
Salary
0
Seniority
Senior
Job Description
Medical Writer – Clinical Specialist
Retinai
• collaborate with internal and external stakeholders to prepare clinical study deliverables and clinical documents supporting submissions to regulatory agencies for Software as Medical Devices, including AI-based products. • collaborate in writing and maintaining Standard Operating Procedures to ensure organizational alignment with global regulatory standards. • draft and refine Instructions for Use (IFU) and User Manuals to ensure complex AI-based software functionalities are accessible and clear for clinical end-users. • prepare critical clinical investigation documents, including Clinical Investigation Plans (CIP), Clinical Investigation Reports (CIR), and Informed Consent Forms (ICF). • prepare Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER), including conducting systematic literature reviews to substantiate product safety and performance. • collaborate in the preparation of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) plans and reports, and Periodic Safety Update Reports (PSUR) to maintain regulatory compliance. • Support the company’s clinical evidence strategy by drafting high-quality scientific publications, white papers, and abstracts for international conferences and peer-reviewed journals. • Support FDA clinical study design
Job Requirements
- University degree in Biomedical Engineering, Pharmacy, or similar.
- Minimum of 5 years relevant work experience, thereof 2 to 3 years of experience in a medical device company and a good understanding of Regulation (EU) 2017/745 (EU MDR), ISO 14155 standard requirements, ICH E6 (R3) Guideline for good clinical practice (GCP) and 21 CFR Part 812, as well as MEDDEV 2.7.1/rev4 and MDCG guidelines related to clinical evaluation and post-market surveillance
- Previous experience with FDA clinical study design support (i.e FDA 510k and/or FDA Denovo pathway)
- Proven project management skills
- Strong communicator with proven ability to manage and communicate with internal and external stakeholders
- High level of interpersonal skills
- Self-starter with a high degree of autonomy
- Experience in the Ophthalmology field is a plus
- Experience with AI in medicine is a plus
- Fluency in English
- Skilled in the use of Microsoft Office and/or Google G-suite applications (Word, Excel, PowerPoint and / or Docs, Sheets, Slides).
- Willingness to travel occasionally (up to 4 events per year).
Benefits
- A chance to be part of an exceptional team driving innovation in healthcare.
- A competitive salary in a supportive work environment that fosters work-life balance.
- Opportunities for professional growth and development in an international setting.
- A culture of collaboration and inclusion, which is fundamental to our ethos.
- Occasional travel to our HQ in Switzerland, immersing you in our core operations and company culture.
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