Medical Writing & Biostatician Lead
Ray -
Dokki, GizaPosted 2 years ago30Applicants for1 open position
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- 1In Consideration
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Job Description
- Accountable for setting the strategy and operational execution, related to medical writing activities and deliverables within Integrated Data Analytics and Reporting data management, risk management – central monitoring, statistical programming and medical writing), in line with Medical Affairs’ priorities and Therapeutic Area objectives, in close collaboration with the Medical information Manager and the Medical Director, the Clinical Development Operations Portfolio Delivery groups and Quantitative Sciences (QS), in order to ensure success in efficiently providing high quality deliverables.
- Accountable for MW resource management and allocation.
- Responsible for the management and development of all Medical writers employees within the organization to meet current and future business needs.
- Accountable for setting the strategy and operational execution related to medical writing activities and deliverables of the Regulatory Medical Writing group. This includes :Establishes the strategy and direction of Regulatory Medical Writing within the organization and RAY strategic objectives.
- Interacts with leaders to establish organizational priorities, ensures alignment of MW's, and executes on the organizational priorities, with a focus on quality MW deliverables.
- Oversees the MWs team and assures timely completion of deliverables for all areas of clinical research within the assigned therapeutic areas.
- Ensures the MWs strategy and processes are clear towards all stakeholders by organizing clear and consistent communication around it.
- Accountable to ensure that the Regulatory Medical Writing services are in step with or ahead of best practices in the industry with regard to effectiveness and efficiency, and ensures continuous evaluation, benchmarking, and process improvement.
- Accountable for the development and consistent implementation of Regulatory Medical Writing processes,Ensures compliance to departmental, company and company policies and requirements; also ensures that up-to-date technology platforms are available to support the MWs processes and resources in the most optimal way, in close partnership with relevant parties like Enabling Business Information Solutions.
- Aligns MW processes and priorities to maximize MWs effectiveness; implements innovative approaches to enhance productivity and effectiveness.
- Implements end-to-end document and reporting standards, and drives adherence to standards in trials/programs and regulatory submissions.
- Oversees initiatives related to process improvements, regulatory compliance and other key department, cross-functional activities as assigned. Participates in and/or lead cross-functional and cross-sector initiatives.
- Provides leadership to the MWs team by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. The position is responsible to create an environment where employees feel engaged and empowered, and take pride in their role, responsibilities and deliverables.
- charged with making decisions associated with the management of assigned personnel
- Design and manage the implementation of the Medical BioPharmaceuticals product strategy globally and regionally
- Create and develop the strategic direction, business/resource planning, and team leadership on a global level for the product, in collaboration with the Medical Director
- Cross-functional leadership and collaboration across all Medical Bio Pharmaceuticals functions (e.g. Strategy & Operations and Medical Evidence)
- Closely follow medical developments within Therapeutic area and disseminates new information to transform clinical trends and emerging data into new plans
- Develops data collection. Coordinates and carries out data collection, processing, and analysis. Provides consultation on design of data processing systems, specifying the needed output, the required input and the methods of validation and quality control
- Responsible for ensuring the statistical validity of study activities by solving problems occurring in the data collection process.
- Recommends analytical design for a broad range of data. Recommends the most appropriate statistical procedures for evaluation of outcome of studies. Uses a wide variety of statistical procedures including but not limited to categorical data analysis, exploratory and graphical methods, analysis of variance, correlation analysis, multiple linear regression, time series analysis, logistic regression, survival analysis, spatial analysis, and non-parametric methods.
- Responsible for leading the initial development and ensuring the accuracy of medical promotional materials and communications prior to submission
- Provides technical leadership, consultation, advice on statistical analysis, methods and techniques for research studies.
- Ensure the execution of RAY mission and vision.
Job Requirements
- Medical Background
- Min 5 Years Experience
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