Medical Affairs Supervisor
Job Description
Medical Affairs Supervisor
Job Description
Helping in preparation and maintaining CE Files registration, Key responsibilities include: Prepare regulatory documents and responses to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs) understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, and EU MDR 2017/745. Perform systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical devices Perform routine literature searching for specific medical devices Perform full Comparison between different medical devices to demonstrate equivalence Perform critical review and data analysis from clinical investigations and literature for incorporation into the CER Serve as the regulatory writer on assigned CER projects, collaborating with the CE Scientific Quality Manager to meet all project deliverable timelines Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates Supports the clinical study review and approval process through supporting documentation and assisting with responses to regulatory authority (e.g., FDA, Competent Authorities) questions, if applicable. Preparing Risk assessment sheet for each CE product
– Medical Affairs Specialist help to organize and monitor the different phases of clinical trials of drugs. Key responsibilities include: Writing drug trial methodologies (procedures) Identifying and briefing appropriate trial investigators (clinicians) Setting up and disbanding trial study centers Designing trial materials and supplying study centers with sufficient quantities Providing clinicians with instructions on how to conduct the trials Collecting and authenticating data collection forms (commonly known as case report forms) Monitoring progress throughout the duration of the trial Writing reports
– Preparation and Reviewing of medical and scientific files. Key responsibilities include: Responsible for the preparation of scientific files requested by Drug regulatory affairs (local and Export) Responsible for the preparation of Pharmaco-economics files requested by Drug regulatory affairs (local and Export) Aid in the preparation of the naming list of the new products Formulation of insert leaflets for new products and non-referenced product Literature searching Reviewing of all inserts, layouts, labeling and stickers of local and Export Drug regulatory affairs for scientific accuracy Reviewing and editing of all medical content on Brochures, Flyers and Websites to ensure the validity of all medical information and relevancy of scientific information at marketing projects Participate in scientific meetings such as advisory boards and develop reports for it. Disseminate, review and present clinical and scientific data to the intended audience. Analyze scientific studies to extract relevant information that serve the objectives of the project. Develop scientific communication materials such as slide decks, communication tools, reports…etc. for HCPs and lay audiences. Cross-referencing of medical content and facts check for MOH approvals. Translate medical content if/and when needed.
Skills
Minimum 2 years experience in medical field Be appropriately qualified & experienced / trained (has adequate theoretical & practical knowledge for the performance of clinical trials activities). Be a pharmacist with at least a bachelor degree in pharmacy and have constant access to medical expertise. Be available 24 hours (contact details / phone number). Have the skill for the management of medical insights and strategies
Education
Pharmacy
Job Location Cairo, Egypt Job Role Medical, Healthcare, and Nursing Years of Experience Min: 2 Max: 5 Residence Location Egypt Job Role: Medical, Healthcare, and Nursing Experience: 1 – 3 Years of Experience
