Associate Director​/Manager, Product Labeling; Hybrid

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work‑life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Associate Director, DRA Product Labeling will lead and manage the coordination of operational activities of labeling/packaging matters for assigned BIPI marketed products including label compliance reviews, development and maintenance of packaging components, liaison between the corporate design office, graphic offices, and production sites for implementation per established timelines and in line with local regulations, corporate compliance and business objectives. This role will manage overall operational activities to support late‑stage development labeling for NCEs/NBEs and labeling supplements, in conjunction with the assigned RA Labeling Content Manager and Product Manager in the RA Product Groups.

The AD, DRA Product Labeling will participate as a PLRT member contributing to the compliance and grammatical aspects of the content of labeling. Additionally, when required, the incumbent will present packaging concepts for consideration. The position holder will continuously evaluate innovative opportunities to improve efficiency and execution of process to support labeling initiatives in compliance with Corporate and local regulatory requirements.

The AD, DRA Product Labeling Operations will provide training, advice, and mentoring to affected cross‑functional colleagues and within Labeling Operations, as appropriate, for labeling related procedures. The incumbent will provide functional support to label management as needed and assist/manage the overall operational activities of the DRA Labeling Operations Group to keep priorities in line with business goals.

• Independently communicates via established procedures with SLCI responsible or labeling services to revise and create artwork for various labeling components for assigned BIPI marketed products.
• Ensures that timelines for revised artwork are adhered to as to minimize impact on production.
• Interacts with Corporate Design Office as needed for US labeling changes to ensure consistency with design guidelines or requests for local deviations.
• In collaboration with Supervisor and upon Supervisor request, provides training (using available training materials or create new training materials) to affected cross‑functional colleagues, as appropriate, for labeling related procedures.
• Mentors the BIPI RA Product Labeling Operations staff responsible for operational management in collaboration with Supervisor.
• Continuously identifies needs and develops and/or maintains local procedures to support labeling initiatives in compliance with Corporate and local regulatory requirements.
• Provides guidance, training, and technical expertise to labeling specialists and labeling managers for the preparation and approval of Structured Product Labeling (SPL) files.
• Collaborates with planning function to elevate and present requests to senior management to deviate from compliance implementation dates.

• Ensures labeling components for BIPI US late‑stage development projects, new product launches and post‑marketing labeling revisions comply with Corporate Design guidelines and local regulations.
• Influences critical labeling operational activities as appropriate to successfully generate quality documents with internal customers and with FDA to achieve timely labeling reviews/approvals in alignment with business objectives.
• Works closely with staff and project/product responsible DRA colleagues…