Manager, U.S. Label & Launch Operations, USPI Production

Working with Us
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Position Summary:

The Manager, U.S. Label & Launch Operations, USPI Production is responsible for managing the operational processes associated with USPI production in the U.S. market. This role will drive and execute production of the U.S. Prescribing Information and all derivative documents across therapeutic areas to ensure compliance with prescribing information and FDA guidelines.

The role works closely with the Proofreading team, Labeling Operations, Commercial Regulatory Affairs, and Worldwide Commercialization Excellence (WCE) on execution of all label updates and launches.

The role will be part of a team responsible for the seamless implementation of prescribing information and all derivative labeling documents across all brands. 

This is an important role within U.S. Commercialization Strategy & Operations Organization and key to Bristol Myers Squibb’s ambition to continue advancing the efficient and expeditious execution of launch and label update operations. In this position, this individual will report directly to the Associate Director, U.S. Label & Launch Operations.

Key Responsibilities:

• Drive the creation of InDesign layouts of USPI documents to ensure all follow FDA and BMS regulations and Brand guidelines. 

• Develop Photoshop versions of labeling documents per specifications. 

• Develop artwork and illustrations as required for Global Regulatory, Packaging, and R&D. 

• Develop and maintain Universal Patient Language Important Safety Information aligned with Brand guidelines and UPL ISI templates. 

• Manage multiple projects in tandem and with expedited timing. 

• Deliver materials with the utmost quality, while implementing content updates with meticulous eye for detail. 

• Develop and maintain strong relationships with key stakeholders. 

• Partner with Proofreading team to ensure documents are consistent with regulations and error-free. 

• Remediate all U.S. Prescribing Information PDFs for ADA compliance to post to digital platforms. 

• Identify opportunities for efficiency and communicate with leadership areas for improvement. 

• Develop subject matter expertise in all production areas supported by USPI Production. 

• Troubleshoot problem files or processes for seamless support. 

• Develop expertise in all guidelines and requirements of USPI Production. 

Qualifications & Experience:

•  Expertise in Adobe Creative Suite.

• Familiarity with Figma and XD.

• Exemplary skills in remediating complex PDFs. 

• Meticulous eye for detail and long-term experience in the InDesign creation of mechanicals with heavy text. 

• Experience working in a multi-channel environment and ability to work in a matrix team setting

• Ability to navigate complex and continually evolving organizational environments.

• Strong written and verbal communication and presentation skills.

• Ability to work on multiple projects with competing deadlines. 

• Experience working with leadership and communicating directly with senior leaders. 

• Ability to learn new technology and systems quickly.

• Pharmaceutical experience required.

• Expert in complex PDF remediation.

• Minimum of 10 years of production experience required
   

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transfo