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The Senior Project Manager CMC will lead CMC development and regulatory activities, ensuring alignment with internal and external stakeholders and compliance with GxP standards.

As a Senior CMC Specialist, you will lead analytical methods development, manage GMP activities, and ensure compliance for regulatory submissions in biologics development.

The Associate supports Third Party Due Diligence & Risk by executing due diligence, onboarding vendors, monitoring risks, and ensuring compliance with procurement processes. Responsibilities include maintaining supplier documentation, tracking vendor statuses, and collaborating with stakeholders to manage vendor risk effectively.

The role involves strategic planning and execution of regulatory submissions (J-NDA) related to CMC for pharmaceutical products, including preparing high-quality dossiers, vendor management, and lifecycle management. Collaboration with cross-functional teams is essential to ensure compliance with regulatory guidelines and submission strategies.

Lead advanced analytics strategy for commercial success, shaping opportunities, implementing data-driven solutions, and mentoring a team of data scientists to influence decision-making in a fast-paced environment.

The Programming Intern will assist with compliance and data quality initiatives by automating CMS data validation processes and analyzing data mismatches. The role involves developing automation solutions and insights to improve submission accuracy and operational efficiency, collaborating with cross-functional teams.

The Associate Director, Category Lead will develop and execute strategic sourcing initiatives in Tech Ops, negotiate with suppliers, and engage stakeholders to align procurement efforts with business goals.

The Associate Director, Operational Excellence leads project management initiatives, drives operational tools development, ensures process consistency, and collaborates across teams for strategic project support in late-stage manufacturing development at Genmab.

The Associate Director, Contract Management leads a global team in overseeing the management of Clinical Trial Agreements, ensuring compliance and efficiency while fostering collaboration across various departments, including Legal and Finance.

The Commercial Supply Chain Planner coordinates supply activities across global operations, ensuring compliance and continuity of product supply. Responsibilities include managing production planning, CMO engagement, and utilizing ERP tools.