Immediate Need in Deerfield IL for a Project Manager. 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, be fluent in English (both writing and speaking) and possess critical thinking and analysis skills. Expected to last 12 months, possible temp to perm.
location: Deerfield, Illinois
job type: Contract
salary: $70 - 80 per hour
work hours: 8am to 4pm
1. Facilitates communication between the World Wide Medical (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:
o Clinical Evaluation Plans (CEP),
o Clinical Evaluation Reports (CER),
o Post-Market Clinical Follow-up Plans (PMCFP),
o Post-Market Clinical Follow-up Reports (PMCFR),
o Post-Market Clinical Follow-up L2 activities, and
o 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., Subject Matter Experts) such as WWM-Medical Affairs, Post Market Surveillance (PMS), Product Quality (PQ), Research & Development (R&D), Regulatory Affairs (RA), Global Patient Safety (GPS), Global Business Unit (GBU) Project Managers, and potentially external vendors in order 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 and/or participates in the 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 determine risk reaction (Acceptance, Mitigation, Escalation). Anticipates potential deliverable schedule conflicts and challenges for proactive solutions and manages deliverable schedule. Ensures escalation of any unresolved deliverable delays or risks to leadership within WWM, as well as the 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 Teamcenter (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.
- Experience level: Experienced
- Minimum 5 years of experience
- Education: Bachelors (required)
- Project Manager
- Product Development (5 years of experience is preferred)
- Medical Device (5 years of experience is preferred)
- Life Science (5 years of experience is preferred)
- PMP (5 years of experience is preferred)
- PMI (5 years of experience is preferred)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.