Product Labeling Project Manager (Remote/Flexible) (Finance)
The Product Labeling Project Manager will play a critical and leading role in providing operational oversight to meet critical program deliverable dates. The Labeling Project Manager is responsible for leading multiple moderate to complex projects within a product labeling program from initiation through project closure.
Responsibilities:
- Responsible for owning, managing, and monitoring multiple simple to complex product labeling projects from initiation through completion and product labeling is ready for print in collaboration with the project labeling team.
- Lead cross-functional meetings and influence stakeholders and team members to drive alignment, develop plans and deliver results. Build team ownership and commitment to project plans
- Partner and collaborate with a variety of functions to achieve project objectives. This includes identifying resources required for project activities, timeline development, and project prioritization.
- Prioritize, delegate, and manage tasks among projects and team members, as appropriate, to drive execution of project deliverables and minimize risk.
- Develops project scope summary descriptions and rationale based on labeling request and requirements as applicable.
- Create and manage schedules to track labeling projects to successful completion.
- Lead or participate in cross-functional planning sessions for product labeling projects.
- Creates and manages all critical key performance indicators (KPIs), key metrics and reporting for stakeholder visibility and awareness of critical product labeling deliverables.
- Manages & supports product labeling translation activities for product labeling and provides oversight to product labeling team in support of translation activities.
Required Qualifications:
- Bachelor's degree
- 5+ years Project Management experience in the Medical Device or Life Sciences industry
Preferred Qualifications:
- Demonstrated project management experience leading cross functional teams and managing project scope and schedule.
- Must have ability to understand medical/clinical and technical aspects of product.
- Experience managing product labeling projects is preferred or other comparable experience
- Translation management experience preferred
- PMP Certification preferred
- Demonstrated working knowledge of FDA labeling and other Regulatory Requirements
- Expert knowledge with MS Office suite including MS Project
- Experience with Smartsheet highly recommended
- Ability to use systems and tools to design and develop operational metrics and reporting.
- Experience with document management systems, such as Agile PLM and SharePoint.
- Excellent writing, communication and organizational skills
- Demonstrated problem solving / issue resolution skills
- Ability to understand and communicate product knowledge.
- Team player capable of working with and influencing cross-functional project teams.
- Ability to multi-task, organize, judge priorities and provide guidance to other product labeling team members.
- Ability to comply with SOPs, regulatory guidelines, etc.
- Ability to travel intermittently (up to 10%) to support effective team performance and collaboration.
NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote
Additional Information:
The US base salary range for this full-time position is $118,500.00 - $177,750.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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