Director II NBE (New Biological Entity) Author

Company Description

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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

Job Description

The Director II NBE Author leads the development and oversight of Chemistry, Manufacturing, and Controls (CMC) dossier strategy and authoring to support CMC regulatory deliverables such as INDs/IMPDs and Marketing Applications. Responsibilities include working with the CMC project team and external stakeholders to develop cutting-edge control strategies and influencing the generation of data packages that support the CMC control strategy.  The Director II oversees a team of authors that write the narrative sections of CTDs to communicate a single, integrated strategy to health authorities, contributes to the preparation of regulatory query responses and briefing books, and serves as a subject matter expert (SME) for technical topics related to dossier content. The Director II also partners with functional leads to create AbbVie best practices and influences across internal and external stakeholders to address emerging module 3 topics

Responsibilities:

• Leads a team of Dossier Leads and Dossier Authors with ultimate accountability for the creation of high-quality submission content by establishing best practices, coaching and mentoring.
• Conducting management reviews for INDs, IMPDs, NDAs and BLAs to ensure clear and consistent messaging of the control strategy across the filing.
• Participates in CMC Governance meetings to provide expert guidance in the creation of data sets for high quality submissions, real-time perspectives on regulatory expectations on data packages, and risk identification and mitigation strategies.
• Skilled in influencing diverse teams with varying priorities and working styles to achieve project goals.
• Independently identifies opportunities for improvement of departmental work processes and man