job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed!
location: Deerfield, Illinois
job type: Contract
salary: $70.00 - 74.34 per hour
work hours: 9 to 5
- 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:
- 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)
- 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).
- 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.
- 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.
- 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.
- Schedules and/or participates in the deliverable kick-off meetings to confirm deliverable scope, project schedule, assigned SMEs, and availability of source documents.
- 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.
- 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.
- 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.
- Implements an effective communication model with cross functional team members that provides deliverable status updates and supports timely completion of deliverables.
- May participate in workshops and company initiatives to help define processes globally and to provide best practices for continuous process improvement.
- Minimum of a bachelor's degree
- At least 3 years of on-the-job project management experience required
- 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
skills: Project Management, MS-WORD, MS-EXCEL, MS-Project
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.