ICON Strategic Solutions Company Is Starting Urgent Recruitment For The Following Multiple Positions For All Nationalities In Qatar ( 107 Remote Vacant Job )

• Deliver Trials(s) on time, within budget, and with highest achievable quality.
• Assist in the review, development and/or writing of clinical trial documents and manuals as needed, including but not limited to Protocol, Case Report Forms, informed consent forms, Clinical Study Report and other regulatory documents.
• Manage the evaluation and selection of investigative sites for applicable clinical trials, responsible for feasibility.
• Select, coordinate, and monitor activities of vendors.
• Review of monitoring reports and conduct co-monitoring visits, as needed.
• Develop and manage trial(s) timelines, budget and priorities.
• Participate in data review and discrepancy resolution.
• Ensure set up and maintain all systems in order to plan and implement trial(s) and track progress.
• Generate reports to update management on progress of the clinical trial(s)
• Ensure appropriate clinical trial supply plans are implemented and managed where appropriate
• Develop recruitment plans, risk-mitigation plan, monitor, and implement contingencies as required.
• Participate in monitoring study/program safety.
• Develop key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
• Perform initial review of CRO and other third-party vendor training on protocols, guidelines, and/or practices.
• Lead multi-disciplinary trial teams, including the study team meetings.
• Function as the primary contact for program(s) between Drug Development and other departments

• Drives the design of all assigned project level submission documents in support of the Clinical Development Plan (CDP) 
• Validates the individual study protocol design and clinical study report (CSR) key messages.
• Contributes to the project level data presentation strategy and messaging standards 
• Authors other clinical regulatory documents, as required such as IND, NDA/MAA/BLA, Clinical Overviews, Clinical Summary of efficacy & Integrated summary of efficacy, Clinical Summary of Safety 
• Mentors Senior Scientific Medical Writers and Scientific Medical Writers in developing expertise in writing clinical, regulatory and submission documents.

•  Expertise in pharmacovigilance requirements relating to marketed products and clinical trials across all major markets
•  Extensive signal detection & management experience is a must.
•  Understanding of the principles of databases, querying data sources as well as developing and applying search strategies
•  Working knowledge of MedDRA
•  Excellent attention to detail, data interpretation and medical-scientific writing skills
•  Advanced critical thinking and problem-solving skills with ability to evaluate and escalate appropriately Solid project management skills with the ability to manage multiple projects simultaneously and ability to redress issues proactively with limited management intervention
•  Ability to motivate, mentor and provide guidance to less experienced staff, routinely exhibiting robust and proactive scientific expertise
•  Excellent oral and written English language communication skills, including paraphrasing skills
•  Advanced computer skills with the ability to work within multiple systems; advanced skills in Microsoft Office products (including Outlook, Word, and Excel)
•  Working knowledge of Oracle Empirica.
•  Ability to maintain a positive and professional demeanor in challenging circumstances and to proactively plan for likely scenarios using personal experience
•  Ability to work effectively within a team to attain a shared goal

• Represents the regulatory project and submission management (RPSM) group in cross-functional planning to develop global regulatory submission and execution plans in line with the client’s needs and regulatory team goals. 
• Partners with document providers to project manage the timely receipt of submission ready documents for inclusion in global dossiers. 
• Communicates external agency submission standards and internal business submission processes to ensure compliance and efficiency in the delivery of submission. 
• Ensures that company is aware and responsive to external guidelines, regulations, changes in the marketplace and other information relating to global regulatory project and submission management.

• Leading and performing the assessment of medical safety data for assigned products
• Developing and executing safety signaling and benefit-risk management strategies
• Closely collaborating with stakeholders internally (e.g. Regulatory Affairs, clinical development, medical affairs) and externally (e.g. Key Opinion Leaders or regulatory agencies) to align safety communications and to ensure the safe use of products
• Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting 
• Perform safety signal management and benefit risk assessment activities as well as other regular and/or ad-hoc aggregate safety data reviews as needed for assigned product(s)
• Lead cross-functional teams to perform regular and/or ad-hoc review of existing and emerging aggregate safety data for assigned product(s)
• Contribute to the development of the overall safety governance structure and activities
• Provide safety strategies and deliver accurate, timely and high quality safety contributions for the preparation of relevant sections of regulatory submission documents globally (e.g. ISS, SCS, narratives) for assigned product(s)
• Prepare and/or review safety sections of clinical/regulatory documents (including study protocols, IBs, Clinical Study Reports, or ICFs)
• Provide medical safety support for the preparation of responses to regulatory authority inquiries. Assure that safety information is timely, complete, and accurate
• Lead the overall preparation of periodic safety reports (e.g. PSUR, DSUR); provide medical safety content and ensure consistency and quality of these documents
• Oversee the medical assessment of individual case safety reports (ICSR) 
• Confirm criteria and content for expedited reporting and unblinding (e.g. SUSAR or urgent safety issues) 
• Lead or actively contribute to the preparations and presentation of safety information to the Data Safety Monitoring Board (DSMB)
• Provide medical safety contributions at internal audits and regulatory inspections 

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