Project Manager 2 - Product Labeling at Dexcom in San Diego, California

Job Description:

About Dexcom

Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class-while empowering the community to take control of diabetes. Dexcom reported full-year 2020 revenue of $1.9B, a growth of 30% versus 2019. Headquartered in San Diego, California, with additional offices in the U.S., Europe, and Asia Pacific, the company employs over 6,000 people worldwide.

Essential Duties and Responsibilities:

• Supports product labeling projects from planning and development through production release and revision.


• Serves as a supporting labeling resource on projects and product core teams up to commercial distribution and maintains involvement throughout the product labeling lifecycle.


• Understands quality management system and follows applicable procedures to ensure compliance with business and industry standards as well as regional and local regulations.


• Partner with Labeling Program Managers to prioritize and plan labeling-related schedules, milestones, and deliverables in support of global and regional product launches or labeling change projects.


• Maintains labeling requirements, including language translations, and helps coordinate with other functional project managers and approved suppliers to facilitate on-time execution.


• Prioritizes among competing needs and opportunities; tracks and maintains updates for multiple projects simultaneously; utilizes project management tools as applicable.


• Demonstrates developing business judgment and innovation in approaching business challenges.


• Understands design controls, medical device labeling, artwork production, labeling translation, and project management tools and techniques.


• Maintains knowledge of industry requirements and supports implementation within regional compliance databases.


• Other duties as assigned.

Required Qualifications:

• Bachelor's Degree or equivalent years of experience


• Experience in medical device labeling translations and localization for the US, EMEA, APAC, or a combination thereof


• Knowledge of GDP, GMP, FDA, UDI, MDR, and ISO requirements and standards


• Proficient with MS Office, including Outlook, MS Project, and Visio


• Experience with document management systems, such as Agile PLM and SharePoint


• Ability to build relationships across functions and business units


• Able to work in a fast-paced environment and meet aggressive timelines


• Excellent organization, prioritization, problem solving, and communication skills


• Resourceful, innovative, and possesses the ability to work with general direction and oversight

Preferred Qualifications:

• Black Belt or Green Belt certification


• Proficient in Confluence


• Familiar with Content Management tools, such as MadCap Flare/Central


• Familiar with Requirements Management tools, such as DOORS

Functional Description

Performs non-technical project completion using an internal customer perspective, typically from initiation through delivery. Monitors the project from initiation through delivery including planning and directing schedules, assessing scope, and monitoring budget/spending. Coordinate cross-functional teams through meetings, monitoring team performance, and progress measurement activity which bring distinct, specific projects to completion both on time and within budget.

Functional/Business Knowledge

• Developing professional expertise,applies company policies andprocedures to resolve a variety ofissues.


• General application of concepts and principles.


• Demonstrates project management skills and successful track record of completion.


• Contributes to the development of new concepts, techniques, and standards.

Scope

• Receives general oversight and guidance on approaches to compete project related tasks.


• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.


• Develops solutions to a variety of problems.


• Builds productive internal/externalworking relationships.

Judgement

• Exercises judgment within defined procedures and practices to determine appropriate action.


• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.

Management

• N/A

Field Sales

• N/A

Experience and Education

• Typically requires a Bachelors degree and a minimum of 2-5 years of related experience.

Workplace Type

• The Workplace Type for this role is Flex. Based on the nature of your position you will be working onsite approximately 2-3 days per week from collaborative space and hoteling desks at our Dexcom sites. You will need to be located within commuting distance (typically 75 miles/120km) of your assigned Dexcom site.

If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at talentacquisition@dexcom.com.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.

View the OFCCP's Pay Transparency Non Discrimination Provision at this link.

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