Labeling Project Leader
The Project Leader I leads project teams to project closure with limited direction. There is a level of independent interaction, influence, and leadership with the project team to ensure the team keeps the project on track and delivers to commitments. The Project Leader I role is guided by the product lifecycle management processes. The individual in this role will be strengthening their independence and strong leadership and project management skills to evolve to leading larger projects.
Essential Duties and Responsibilities
- Responsible for owning and managing multiple labeling change controls.
- Identify and collaborate with multi-functional labeling Subject Matter Experts (SMEs), such as Regulatory, Product Design Owner (PDO), Engineering, Manufacturing, Quality, Packaging, and Print Suppliers, to obtain the requirements and content for labeling.
- Utilize compiled requirements to create or obtain a consolidated redline(s) that reflects all changes to labeling content and labeling specifications.
- Obtain approval of labeling specification content. Obtain draft and/or final artwork based on the labeling requirements.
- Manage labeling translations activities, as needed.
- Drive labeling changes and manage them through the change control process from initiation through implementation (change ownership and communication).
- Responsible to perform accurate product data entries and linkages in document management system, change data entries in the change control management system; and project data entries in labeling project SharePoint site, and review the data input of others for accuracy and compliance to procedures (i.e., CS3 role).
- Coordinate Bill of Materials creation/changes and obsolescence of superseded labeling per change plan.
- Working knowledge of products and processes within a regulated environment.
- The incumbent will perform other duties as assigned.
Qualifications for this role
- Experience as a change control owner.
- Experience with pharmaceutical labeling or regulated environment preferred.
- Good interpersonal, communication, influencing, and negotiation skills.
- Organized, analytical and comfortable with data analysis and numbers.
- Proficient use of Microsoft Office (Word, PowerPoint, Excel, OneNote, SharePoint).
- Basic understanding of Microsoft Project and project schedules.
- Team spirit minded, can collaborate well in a team and can work autonomous on identified and specific tasks.
- Customer minded; strong communication skills: with ability to interact effectively with all levels of local and international organization.
- Experience leading global cross-functional and cross-divisional teams.
- Knowledge of product/document configuration management.
- Working knowledge of related business systems.
- Detail oriented individual.
- Experience working in a global environment.
- Bachelor’s degree or equivalent experience with management/documentation systems, or equivalent change control system.
- 1-2 years of experience performing product or labeling change control responsibilities, with use of TrackWise 8 system or equivalent change management system in pharmaceutical and/or medical device environment (QA, RA, R&D, Mfg, Supply Chain) preferred.
- 1 year of project management.
A Career That Matters
Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.