Project Management Specialist (Lab Diagnostics - Product Labeling)

Newark, Delaware
04 Oct 2016
24 Dec 2016
Oil and Gas
Contract Type
Full Time
Division Healthineers
Job Type Regular

Business Unit LD - Laboratory Diagnostics
Job Time Full-Time

Functional Area ENG - Engineering
Experience Level Mid Level

Req ID 155165
Required Education Bachelors Degree

Location DE - Newark, NY - Tarrytown
Required Travel 20%

Division Description
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthcare and Financial Services.

The Siemens Healthcare Division develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.  As a global leader in medical imaging, laboratory diagnostics, and healthcare information technology, we have a keen understanding of the entire patient care continuum-from prevention and early detection to diagnosis and treatment.  

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Job Description
This position is responsible for managing the development and release of all Product Labeling deliverables on new product development teams for a major development program. This position is responsible for developing and maintaining detailed project plans, project budgets, and design control documents (e.g. project plan, design input requirements, design outputs, verification plan & report). This position will be responsible for managing and delegating tasks to assigned resources to ensure high quality, on-time completion of design outputs and project deliverables. This position operates as a strong project manager, strong leader, independent subject matter expert, knowledgeable resource, facilitator and coach to the Product Labeling project team.

- 6-9 years of experience as a Project Manager, Project Planner or Project Analyst, with a minimum of 3 years as a mid-level Project Manager, or higher, in an FDA regulated design control environment.
- Project Management Professional (PMP) certification not required but can be a differentiating factor.
- Thorough knowledge and understanding of FDA design control requirements required.
- Experience as a Technical Writer and/or direct experience in the delivery of customer documentation desired.
- Understanding of product labeling processes and workflow, and relevant manufacturing processes desired.
- Leadership skills and ability to motivate a team without direct line authority.
- Positive attitude and ability to develop effective relationships with all levels of personnel.
- Experience working in IVD, medical device, pharmaceutical or other regulated industry strongly desired.

Major Tasks:
- Represent Product Labeling function on project core team, working with cross-functional team members to ensure successful delivery of new product packaging, instructions for use and customer required documentation.
- Create, manage and maintain project schedule and budget for Product Labeling deliverables.
- Create, manage and maintain all required design control documentation.
- Oversee and delegate tasks to the team of Technical Writers, Graphic Designers and Proofreaders supporting project deliverables without direct line authority, to ensure deliverables are met.
- Identify critical path activities and work with various functions to eliminate road blocks throughout the project lifecycle.
- Actively participate in project team meetings to ensure successful completion of deliverables using standardized project tools and content management systems.
- Responsible for delivering standardized format and content for Product Labeling, providing support, direction and guidance to Technical Writers as necessary.
- Manage and oversee the development and release of each product labeling document from draft through release to customers.

- BA/BS in Life Sciences
- Project Management Professional (PMP) certification preferred, but not required

Siemens encourages qualified long-term unemployed individuals to apply for open positions.

Offer of employment with Siemens is conditioned upon the successful completion of a background check and drug screen, subject to applicable laws and regulations.

Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, disability status, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

EEO is the Law:
Applicants and employees are protected under Federal law from discrimination. Click here to learn more.

Pay Transparency Non-Discrimination Provision:
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. Click here to learn more.