Labeling and Technical Publication Project Manager
Location: Bloomington, Minnesota
Internal Number: R459997
COVID-19 vaccination requirements
Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, COVID-19 vaccines will be required for all Stryker US employees effective January 4, 2022, as well as all new US employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine. If you are applying to a sales and field role which requires access to customer accounts as a function of your job, you may be required, depending on customer requirements, to obtain the COVID-19 vaccination before the January 4 effective date of Stryker's vaccine policy. For more information, please visit our COVID-19 Vaccination Requirements FAQs page.
Why join Stryker?
We are proud to be named one the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com
Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.
Who we want-
Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
What you will do-
Reports to the Manager of IFU and Technical Publications. Responsible for planning, leading, and implementing requirements of labeling projects worldwide within T&E Division. The project lead coordinates assigned departmental and external projects. This person also participates in defining project goals, priorities, schedules, and resources needs. Subject matter expert for labeling systems and processes for the T&E Division. Local contact person for internal and external stakeholders and requests concerning Labeling and TechPub matters. Coordination and replying to respective requests.
Development and maintenance of project scope, detailed plans and resource needs in the field of labeling. Participation in the definition of project strategy, goals, priorities and budget requirements.
Track project progress through regular coordination meetings in accordance with approved plans and regular communication about successes/issues/risks and decisions that impact project or related initiatives with senior management
Subject Matter Expert within the T&E Division regarding Labeling requirements, processes, and tools. - range of stake holders; executive sponsor to user level.
Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes
Coordination and Execution of work packages, priorities and dates with the cross-site and cross-divisional departments (CQR, AO, GQO, R&D, Corporate). Assistance in conflict management between project goals and functional goals in cooperation with the department heads
Contribution to product strategy and roadmap for labeling initiatives and compliance
Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
May coordinate the activities of one or more employees / contractors
May perform other duties as assigned
What you need-
Bachelor's degree in related field required
Minimum 4+ years of experience in medical device and/or Pharma industry required
Minimum 4+ years of experience in labeling, regulatory affairs and/or quality required
Practical program leadership/project management experience in a matrix management organizational structure
Demonstrated ability to independently initiate work and assume responsibility for work that spans functional departments
Knowledge of data sources and systems such as ERP, OnePLM, MasterControl, Label Data Management,
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.
Together with our customers, we are driven to make healthcare better.
At Stryker, quality is first in everything we do. We are driven to make healthcare better for our customers by
providing innovative products and services that meet regulatory requirements through our effective quality system.
The Company was founded in 1941 by Dr. Homer Stryker and incorporated in 1946 as the Orthopedic Frame Company. In 1964, the Company’s name was changed to Stryker Corporation.
• $13.6 billion in annual sales in 2018; annual revenue has grown for 39 straight years
• 17.1% CAGR (compound annual growth rate) in sales over 39 years
• ~36,000 employees globally in 2018
• 43 manufacturing and research & development locat...ions worldwide
• Included in the Standard & Poor’s 500 Index
• Ranked # 233 on Fortune Magazine’s “FORTUNE 500” list for 2019
• Ranked # 3 on Fortune Magazine’s “World’s Most Admired Companies” list for the “Medical Equipment” industry for 2019
• Ranked # 11 on Fortune Magazine’s “100 Best Companies to Work For” list (U.S.) for 2019
• Spent $862 million on R&D in 2018
• 7,784 patents owned globally in 2018
• Initial public offering of stock was in 1979
• Listed on the New York Stock Exchange under ticker SYK