About the Role:
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This position leads global marketing authorization submission management processes, partnering with scientists to create and manage RIM submission content. The successful candidate will provide guidance on structure and content placement, assist with submission related Ministry of Health responses or Lilly affiliate questions, and lead CMC submission management process by providing knowledge of CMC regulatory requirements.
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Responsibilities:
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* Prepare CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements;
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* Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products;
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* Implement and interpret global regulations and guidance into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements;
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* Create an environment that encourages open discussions on issues to achieve a robust outcome on project decisions;
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* Communicate effectively to guide and influence within work group/function and with development team regarding life-cycle management processes;
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Requirements:
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* Bachelor's Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline);
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* Knowledge of pharmaceutical drug development or industry-related experience preferred;
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* Written, spoken and presentation skills;
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* Negotiation and influence skills;
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* Attention to detail and ability to effectively prioritize;
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* Proven effective teamwork skills; able to adapt to diverse interpersonal styles;
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