Please reach out to Pratichi - pjhala(at)divihn(dot)com for more details about this position.Description: Deliverable Project Manager (Medical Devices) **** W2 Only **** Roles: 1
Our Client's ideal candidate: 1. At least 3 years of on-the job project management experience
2. NPD (New Product Development) project management experience particularly in the Life Sciences a plus
3. Works closely with other DPMs to create/refine processes and to ensure consistency
4. Experience in a highly matrixed organization
5. Experience running a project in a multi-cultural/global setting
6. PMI or IPMA or equivalent certification, preferred
7. Experience within the medical device industry, preferred
8. Software: Microsoft: Word, Excel, Outlook, Project and PowerPoint; Adobe Acrobat products; Knowledge in Microsoft Visio and MindManager is a plus.
9. Education: Bachelor's degree (discipline Business or Sciences preferred)
10. Remote position. Local candidates preferred. Summary:
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, be fluent in English (both writing and speaking) and possess critical thinking and analysis skills.
Essential Duties and Responsibilities:
1. Facilitates communication between the World Wide Medical (WWM)-Strategy and 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 and 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 and Development (RandD), 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.
The Project Manager must demonstrate:
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 and MindManager 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:
Minimum of a bachelor's degree
At least 3 years of on-the-job project management experience required
Interview Platform: Phone / Video WebEx
About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.