Clinical Writer We offer to Medical Writers a high profile and exciting job, learning how to operate as a consultant and widening and deepening their professional capabilities. Job Overview: As a Medical Writer specializing in medical devices at our consulting firm, you will be an essential member of our regulatory affairs team, working on diverse projects for various medical device companies. Your primary responsibility will involve creating and refining high-quality, accurate, and compliant clinical and regulatory documents that support our clients' medical device development, registration, and commercialization efforts. Your work will contribute significantly to ensuring regulatory approval and successful market access for our clients' medical devices. Key Responsibilities: • Clinical Document Preparation: Prepare, review, and edit clinical documents for medical device companies, such as clinical evaluation reports (CERs), periodic safety update reports (PSURs), clinical study reports … Ensure that these documents adhere to relevant regulatory guidelines and meet our clients' specific needs. • Project-Based Writing: Collaborate with cross-functional project teams to develop clinical documents tailored to each client's unique medical devices, therapeutic areas, and regulatory requirements. • Literature Research: Conduct thorough literature research to gather relevant clinical data and scientific information to support medical device regulatory submissions. • Data Analysis: Analyze and interpret clinical data and statistical reports to support the content of clinical documents and provide valuable insights to our clients. • Client Interaction: Engage in direct communication with clients to understand their specific requirements, address queries, and provide expert guidance on clinical writing matters. • Document Management: Maintain organized records of clinical documents, versions, and related files for each project, ensuring compliance with document management procedures. • Collaboration and Support: Collaborate closely with project managers, regulatory experts, and other team members to meet project timelines and deliverables effectively. • Continuous Improvement: Continuously assess and enhance our clinical writing processes, templates, and standard operating procedures to optimize efficiency and maintain the highest quality outputs. Qualifications and Skills: ● Education: Advanced degree in a Engineer or life sciences/clinical discipline • Experience: Previous experience in writing documents such as scientific articles, articles, clinical chapters for regulatory submissions… • Language: English at mother tongue level. • Scientific Literacy: Ability to critically analyze scientific literature, clinical data, and statistical reports to create accurate and customized clinical documents for each project. Familiarity with the use of online literature databases. • Writing Skills: Excellent writing skills, with the ability to adapt writing styles to suit different audiences and clients. • Attention to Detail: Meticulous attention to detail to ensure accuracy and compliance of clinical documents tailored to each client's requirements. • Collaboration: Strong team player with the ability to work collaboratively with cross-functional teams and build positive relationships with clients. • Time Management: Effective time management skills to prioritize tasks, handle multiple projects simultaneously, and meet project deadlines. • Ethics and Integrity: Demonstrated commitment to maintaining confidentiality, ethical writing practices, and adhering to regulatory requirements. • Flexibility: Ability to adapt to changing project requirements and client needs efficiently.