Senior Clinical Evaluation Specialist & Regulatory Affairs Specialist
TVM Capital Health Care (AMECO Medical Industries)
Total years of experience :11 years, 10 Months
• - Provide regulatory guidance to project teams to enable accurate decision-making.
- Helps in technical Documentation creation for new products.
- Responsible for creation of Clinical Evaluation (CE) process for new products as well reviewing and updating CE of the ongoing products.
- Responsible for Risk Management (RM) planning and reporting, as well as its updates.
- Responsible for Post-Market Clinical Follow-up (PMCF) and Post Marketing Surveillance (PMS) System, as well as its updates.
- Responsible for Updating and Creating Instruction for Use (IFU) of medical devices.
- Responsible for Vigilance Reporting.
- Responsible for transition from MDD to MDR for the most critical section of TD (CER, RM, PSUR and IFU).
- Responsible for sending the finalized CE, RM and PMS reports to the Quality Assurance (QA) department for documentation.
- Cooperate with QA department in solving problems arising at any stage of product life cycle (From designing stage to packaging and distribution stages).
- Cooperate with Marketing and QA departments in solving complaints arising after post-marketing stage.
- Cooperate with Marketing department in creating Marketing materials for the product families.
- Involved in FDA 510 k submissions (for registration in USA).
- Provide training to team members, trainees and whenever required.
Updating, reviewing and creating SOPs for all departments
• Regular review for all employees’ personal folders
• Ensures that all quality assurance related activities regarding all The organization’s departments, are compliant with all regulatory requirements.
• Establishing a document control and ensuring compliance of SOPs with the local regulations & ICH GCP.
• Ensuring that proper training schedule is set for every employee in the organization
• Conducting internal and external audits to ensure compliance with organization’s SOPs, GCP, Local regulations and all other required regulations.
• Member of the organization’s excellence team, responsible for implementation and follows up of excellence project action plans.
• Reporting of Significant Clinical Quality deficiencies to QA management and helps him to complete corrective action Tasks.
• Developing Quality Operations Process and Procedures for QA in Compliance with applicable regulatory requirements.
• Supporting preparation, Coordination and management of regulatory inspections, including Sponsor/ monitor inspections and Clinical Investigator Inspection.
• Supporting the administration of the Organization’s training Program. Conduct GCP training, clinical Team members, investigators and clinical site staff as needed.
1.recruitment, preparation of trial related documentation (protocols, Case report forms, investigators brochures, consent documents, letters of agreement, confidentiality agreements), organizing trial related regulatory submissions with follow-up to ensure successful outcome.
2. Organize investigator’s start-up meeting and study site initiation meetings.
3. . Ensure that proper drug accountability is maintained in assigned clinical trials sites.
4. Verify all data entries on case report form with source documents.
5. Responsible for prompt reporting and follow-up on all adverse experiences, as required by Protocol, Applicable Regulations and SOPs.
6. Monitoring the assigned clinical trial in accordance with Protocol, Monitoring Plan (if applicable) and SOPs.
7. Planning the requirements for clinical trial materials, ordering clinical trial materials \[CTMs\] (From Sponsor) setting up and monitoring the systems whereby the Monitor Team can ship CTMs to the investigator, maintaining procedures to account for the CTMs, checking the expiration dates of CTMs and requesting extensions if necessary.
8. Keep the study trial master files up to date for all assigned projects to ensure compliance with local, legal and ethical requirements for study conduct.
9. Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly sent to Data Management or entered into the database. Ensure that queries generated are responded to in a timely fashion.
10. Maintain project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigator brochure; protocols; case report forms instructions; consent documents; CTMs shipping orders; start-up meeting attendance documentation; letters of agreement; lab reference ranges; all internal & external correspondences.
11. Administer protocol and study related trainings to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
12. Ensure the quality and integrity of study site practices is compliant with the protocol and applicable regulations and SOPs. Escalate quality issues to Clinical Project Leader (CPL).
13. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
14. Manage patient recruitment strategies (e.g. investigator and research nurse meetings, update newsletters, advertising, letters to PIs).
15. Closely working with the CPL, assuming responsibilities when required.
16. Participate in departmental planning sessions.
17. Provide management to the clinical trial assistants to ensure that their role and contribution is optimized when required.
18. Report Issues of Serious GCP non-compliance, misconduct and fraud as appropriate.
working on medical papers "research paper, medical journal, patient and physicians leaflets, protocols, etc.." for local and multinational pharmaceutical companies
Proofreading and editing final translated versions
Assesse the translator work, and fill in the post translation assessment sheet;
Ensure compliance of the translators with styling guides, and good translation practice and guidelines;
Maintain communications with PM, and translators, and keep the QC officer updated regarding the quality of the revised work; Recommend staff training and point out of the defective areas of expertise;
Working on various translation software;
Assigning and managing projects;
Delivering finished projects to the Project Manager.
training of new translators and revisers
Medway is an Egyptian Agent for 3M organization specialized in marketing of Dental and medical tools and devices and it was launched January 2012.
As a Product specialist my Key duties included the following:
Attain assigned sales, and market share goals in Nasr City and El-Rehab area;
Achieve sales target;
Attend all-important conferences and events related to dentists;
Observe, record and report competitor activities executed in the territory and identify appropriate counter strategy;
Plan, organize and execute product presentation to dentists regarding the use of the product, features and benefits.
Masters of Business Administration
College du Bon Pateur is a private language school, where my first language was french and second language is English. During the 3 years of High school, i succeeded to attend many science conferences as one of the top rank students as well as DELF A2 certificate
Carmelites de St. Joseph is a private language school where 1st language is French and the second is English. i was enrolled as a student since kinder garden to Preparatory stage in this school. as a ranking student in Sciences and Math i attended many competitions in Primary and Preparatory stages. I won the 2nd rank along all the french schools ( Francophones) in the art and literature competition from the CFCC "Centre Francaise de Culture et de cooperation) in 2002. Also our school won the 2nd rank among all schools (Francophone) in art competition from CFCC.