Manager Senior Manager, CMC Dossier Strategy and Leadership (Biologics)

Purpose :

This position participates in global regulatory dossier preparation for AbbVies Biologics portfolio activities by gathering information from internal and external partners and authoring elements of global dossiers. The role prepares sections of regulatory submission documents of high scientific and technical quality that are compliant with global regulatory requirements. Partners with CMC teams during the development of CMC control strategies. Implement well-defined efficient processes for preparation of these CMC documents.

Responsibilities

• Authors sections of IND / IMPDs BLAs / MAAs and regional requirement documents.
• Gathers and / or authors source information from internal and external partners required to support dossier authoring activities.
• Authors data-rich sections of INDs and MAAs based on current best practices. Authors narrative-rich sections of early-phase INDs.
• Embedded in complex CMC development teams to collaborate on forging CMC control strategies and plan for the data packages that will support the strategies.
• Manage IND / IMPDs dossier submission timelines and supporting activities for early-stage programs.
• Participate in quality checks to ensure the accuracy of dossier content and consults SMEs as needed.
• Contributes to developing automation tools to enhance authoring efficiency.
• Independently identifies opportunities for improvement of departmental work processes and contributes to cross-functional process improvement projects.
• Establish and maintain strong networks within departments and external stakeholders. Utilize an established organizational network to identify opportunities gaps and synergies consistent to improve efficiency within role.

Qualifications :

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law :

Note : No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

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.

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more :

Work :

No

Employment Type : Full-time

Key Skills

Marketing,Data Visualization,Tableau,Customer Segmentation,Microsoft Powerpoint,Investment Banking,Strategic Planning,Financial Modeling,Customer relationship management,Management Consulting,Google Suite,Analytics

Experience : years

Vacancy : 1