Project Manager (Mass Spec & Point Of Care)

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The Position

Project Manager (Mass Spec & Point of Care)

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.

The Opportunity:

Roche Diagnostics is seeking an experienced Project Manager to develop, create, document, and facilitate highly professional project plans related to multiple and parallel US FDA regulatory 510(k) submissions for cobas i601 (cobas Mass Spec). This is an exciting opportunity to be a part of a team responsible for shaping the way mass spectrometry is adopted in the future. Cobas Mass Spec is expected to be the most important product launch in RDC over the next decade and the US is expected to lead the world in product sales and contribute over 40% of overall global revenue.

This position will interface between regulatory activities and labeling activities and is responsible for highly complex projects with medium to high risk. These projects have multiple dependencies and require management of parallel processes. This individual will plan and coordinate across multiple stakeholders including Regulatory Affairs, US labeling, US marketing, US Launch Management and Global Marketing.

The Project Manager is a trusted consultant, liaison, and advisor regarding all facets of the project plans. The scope of these projects include diagnostic FDA submissions related to cobas i601, as well as critical future Point of Care products. In year 1 the majority of the Project Manager's time will be dedicated to cobas i601 projects (80%) but that will evolve over time based on priority Core Lab and Point of Care needs.

Key Roles & Responsibilities:

• Design, gain agreement, communicate, and lead the execution of professional project strategies and plans for cobas i601 submissions and Point of Care submissions while adhering to Roche Diagnostics policies and procedures

• Lead and win the commitment of internal Roche Diagnostics stakeholders to follow the defined and align processes

• Collaborate and effectively communicate with project stakeholders and teams to outline work plans and assign duties, responsibilities, and accountabilities

• Champion the program by using existing business processes, compliantly eliminating business processes (compliantly), and/or standing up new processes

• Conduct status update meetings with key stakeholders

Who you are:

(Required Qualifications & Experience)

• You hold a Bachelor's degree

• You hold a minimum of 5 years relevant project management work experience

Preferred Qualifications:

• PMP certification

• Roche process for label creation

• US Regulatory knowledge

• US diagnostics knowledge

• Experience with Lean/Six Sigma business process improvement methodology

• Exceptional teamwork and collaboration skills are essential to facilitate the work of cross-functional and interdepartmental team

• Self-starter with strong analytical and problem-solving skills

• Effective communication skills are critical

• Strong customer service, technical, problem-solving, and organizational skills

• Must be dependable, attention to details, and proficient in coordination tasks

• Ability to work with minimum or no supervision

Location:

• Preferred location: On our campus in Indianapolis, IN, however, we welcome candidates from all US territories as working remotely is a possibility.

• Relocation benefits are not available for this position

• The role is expected to have minimal travel (<15%); however, the preference is for this individual to reside within 50 miles of a major metropolitan airport in the US

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. These products and services are used by researchers, physicians, patients, hospitals and laboratories worldwide to help improve people's lives.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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