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6 days old

Deliverable Project Manager

Kelly Services
Chicago, IL 60684
**Deliverable Project Manager**

**Location:** Remote

**Pay:** $140k+/annually


The healthcare industry requires that we abide by medical device regulations from around the world. Part of the requirements is to produce documents which describe the safety and performance of our medical devices. We are looking for individuals to manage the execution and successful completion of document deliverables to ensure required timelines are met. The ideal candidates must have project management experience and possess critical thinking and analytical skills.


**Essential Duties and Responsibilities:**

This project management role is responsible for managing the execution and successful on-time completion of medical device deliverables owned by Worldwide Medical (WWM) that are required for CE-marking in the EU and Rest of World (ROW).


1. Facilitates communication between the WWM-Strategy & Delivery Team, product teams (SMEs), and the Medical Writer (internal or external vendor) to ensure successful, on-time completion of the following deliverables owned by WWM:


+ Clinical Evaluation Plans (CEP),

+ Clinical Evaluation Reports (CER),

+ Post-Market Clinical Follow-up Plans (PMCFP),

+ Post-Market Clinical Follow-up Reports (PMCFR),

+ Post-Market Clinical Follow-up L2 activities, and

+ Summary of Safety & Clinical Performance (SSCP).


2. Manages the successful completion of above deliverables for the creation of new deliverables (new product development of geographic expansion), regularly scheduled updates (On-Cycle Periodic Updates) as well as ad-hoc updates (Off-Cycle Updates).



3. Proactively partners with cross functional business partners (i.e., SMEs) such as WWM-Medical Affairs, Post Market Surveillance (PMS), Product Quality (PQ), Research & Development (R&D), Regulatory Affairs (RA), Global Patient Safety (GPS) and potentially external vendors to facilitate timely completion of deliverables.



4. Submits Proposed Initiatives (PIs) to the Sustaining Products Organization-Product Core Teams (SPO-PCT) for all on-cycle and off-cycle updates to existing deliverables.



5. Develops deliverable project plans/schedules (if no Medical Writing vendor involved) or monitors deliverable project plans/schedules (if created by Vendor PM); working closely with the Master Schedule Manager and Medical Writer to ensure timelines are met.



6. Schedules deliverable kick-off meetings to confirm deliverable scope, project schedule, assigned SMEs, and availability of source documents.



7. Ultimately responsible to drive the effort in successfully delivering the required documents by the required timelines. If anything places that delivery at risk, collaborates with cross functional business partners to mitigate that risk. Anticipates potential deliverable schedule conflicts and challenges for proactive solutions and manages deliverable schedule. Ensures escalation of any unresolved deliverable delays to leadership within WWM, as well as SME Leadership Team.



8. Owns the historical context of each of the deliverables including why historical decisions were made around each of the assigned deliverables. Communicates this context during the next document update and ensures the required decisions are made based on this history.



9. Collaborates with Medical writers and ensures all source documents are obtained in a timely manner from TcU or SMEs. If vendor is not contracted to provide this data gathering role, Deliverable PM will gather the source documents.



10. Implements an effective communication model with cross functional team members that provides deliverable status updates and supports timely completion of deliverables.



11. May participate in workshops and company initiatives to help define processes globally and to provide best practices for continuous process improvement.


**Qualifications:**

Expertise in project management

Excellent oral and written communication skills

Strong organizational skills, attention to detail, and business acumen

Must possess knowledge and expertise in Microsoft Word, Microsoft Excel, Microsoft Project and Adobe Acrobat products. Knowledge in Microsoft Visio is a plus.

Must have a flexible mindset, able to work in a fast-changing environment with competing priorities

Able to problem solve and resolve issues/obstacles to successfully meet deliverable timelines

Proven ability to work collaboratively with cross functional teams to meet timelines where competing priorities may exist

PMI or IPMA or equivalent certification preferred

Experience within the medical device industry preferred


**Education and/or Experience:**

Completion of a Bachelors degree

At least 3 years of on-the-job project management experience required

Microsoft Word, Excel, PowerPoint, Outlook, Project, Visio, etc


**Why Kelly** **** **?**


Youre looking to keep your career moving onward and upward, and were here to help you do just that. Our financial staffing experts will connect you with premier companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in in your career. It all adds up.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2021-10-11 Expires: 2021-11-11

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Deliverable Project Manager

Kelly Services
Chicago, IL 60684

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