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Labeling Specification Spec

MPHS, TN 38132

Posted: 12/22/2024 Employment Type: Contract Job Category: Regulatory Affairs Job Number: 616785 Is job remote?: No Country: United States

Job Description


HM's Top Needs:

1. IT system testing experience

2. Excellent verbal and written communication and interpersonal skills

3. Basic understanding of ERP systems and integration methods

 

Education Required: Bachelors Degree

Years’ Experience Required: 2+ years/0-1+ years

 

Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, 40 hours

Work Location: Memphis, TN (1800 Pyramid Place)

                Do they need to be local to any MDT office and if so where? Yes

Does this person need to be on site? If so, full time or part time? Yes, hybrid work in office



Responsibilities may include the following and other duties may be assigned.
  • Engages with business leaders to understand how strategies and data-driven changes can improve efficiencies and add value.
  • Works with data sets to define use cases to improve products, processes and/or services.
  • Conducts thorough analysis of business processes and identify areas for improvement.
  • Collaborates with project stakeholders to develop business requirements for product or system changes.
  • Drives business agenda during solution delivery process.
  • Drives business requirements elicitation, solution option selection, User acceptance testing and other project related activities in product labeling.
  • Collaborates with IT to follow Medtronic System Compliance Methodology? (MSCM) process and provides project status updates based on project schedule.
  • Generates necessary MSCM documents in Polarion and owns validation activities.
  • Works with technical, user, and testing teams to perform test scenario identification, test script creation, test data creation, test execution and end user training.
  • Owns and provides support for formal testing activities such as FUT, SIT and UAT as necessary.
  • Partners with project team to oversee any defect management processes.
  • Engages with end users, and vendor as necessary to lead timely resolution of issues during validation cycle of labeling and integrated systems ensuring adherence to project timelines.
  • Collaborates with Cross-Functional Teams and works closely with IT teams to ensure seamless coordination of changes.
  • Provides comprehensive training and support to end-users, ensuring they can effectively use the labeling system.

 

Preferred Qualifications:
  • Medtronic experience.
  • Thorough understanding of end-to-end business process, preferably in Lifesciences industry.
  • Experience with Manufacturing systems and product labeling knowledge will be an added advantage.
  • Basic understanding of ERP systems and integration methods.
  • Experience dealing with customers, upper management, and stakeholders.
  • Ability to multi-task and work on multiple projects simultaneously.
  • Flexibility to handle diverse tasks and responsibilities.
  • Ability to take initiative and work independently managing multiple priorities to achieve goals and objectives.
  • Experience with end-to-end global implementation programs, responsible for designing and implementing the overall solution.
  • Project management experience, with the ability to lead cross-functional teams.
  • Excellent verbal and written communication and interpersonal skills.
  • Collaborative attitude with a problem- solving mindset.
  • Eagerness to learn and continuously improve skills and knowledge.
  • Knowledge of third-party tools such as Polarion, Documentum, HP ALM (Application Lifecycle Management; formerly HP Quality Center), Agile.

 

Required Knowledge and Experience:
  • Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
  • May have practical knowledge of project management.
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About MPHS, TN

Ready to kickstart your career in the vibrant area surrounding Mt. Pleasant High School, Tennessee? This charming region nestled in Maury County boasts a rich tapestry of career opportunities, cultural delights, and natural beauty just waiting to be explored. From the historic Rippavilla Plantation to the lively Maury County Park, this area offers a perfect blend of history, art, and outdoor recreation. With quaint local cafes serving up delicious Southern cuisine, professional theaters like the Cherry Theater, and the chance to catch a game with the local minor league baseball team, the growth possibilities are endless. Join us in discovering your dream job in this unique and enchanting corner of TN!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.