AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
The Program Manager, CMC Dossier Management assists with the development and oversight of Chemistry, Manufacturing, and Controls (CMC) strategic project plans to support CMC regulatory deliverables such as INDs/IMPDs and Marketing Applications.
Responsibilities
Provide dossier support to CMC projects team, including creation and maintenance of content plans, source document maps, rosters, and timelines. Skilled in coordinating diverse teams with varying priorities and working styles to achieve project goals. Independently identifies opportunities for improvement of departmental work processes and contributes to a single large project or several small process improvement projects. Apply project management principles and techniques to the coordination and completion of assigned goals and tasks. Provide regular updates to CMC project team on progress of submission and after the content plan and timeline for the submission are set, ensure team is kept up to date if changes are made. Provide general training support, administration and guidance regarding project management practices and systems. Establish and maintain strong network within department and external stakeholders. Assesses progress against plans, processes, and practices to determine effectiveness and recommend areas for process improvement. Contribute to cross-functional discussions around submission-related risk mitigation strategies. Qualifications
Bachelors with 10+, Masters with 8+, or PhD with up to 4 years of CMC functional experience including late-stage development experience. Prior experience in a relevant laboratory-based CMC function (chemistry, analytical, formulation, etc.) in order to assist CMC project teams in the planning, preparation, review and approval of submission documents. Create and maintain project management tools / templates in order facilitate the submission process. What We Offer
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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Provide dossier support to CMC projects team, including creation and maintenance of content plans, source document maps, rosters, and timelines. Skilled in coordinating diverse teams with varying priorities and working styles to achieve project goals. Independently identifies opportunities for improvement of departmental work processes and contributes to a single large project or several small process improvement projects. Apply project management principles and techniques to the coordination and completion of assigned goals and tasks. Provide regular updates to CMC project team on progress of submission and after the content plan and timeline for the submission are set, ensure team is kept up to date if changes are made. Provide general training support, administration and guidance regarding project management practices and systems. Establish and maintain strong network within department and external stakeholders. Assesses progress against plans, processes, and practices to determine effectiveness and recommend areas for process improvement. Contribute to cross-functional discussions around submission-related risk mitigation strategies. Qualifications
Bachelors with 10+, Masters with 8+, or PhD with up to 4 years of CMC functional experience including late-stage development experience. Prior experience in a relevant laboratory-based CMC function (chemistry, analytical, formulation, etc.) in order to assist CMC project teams in the planning, preparation, review and approval of submission documents. Create and maintain project management tools / templates in order facilitate the submission process. What We Offer
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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