Project Manager
Company: Horizontal Talent
Location: Des Plaines
Posted on: July 28, 2022
Job Description:
Job Description:
- The Regulatory Project Manager will manage the execution of the
company Molecular legal entity name change Project and related
activities to Submission.
- Activities requiring coordination and oversight include but are
not limited to label and registration impact assessment, completion
of Deliverables, Technical file review and preparation of required
documents for submission activities, change management, label
vendor activities, international product
notifications/registrations and inventory control.
- Project management responsibilities include the coordination
and completion of the project on time within budget and within
scope.
- Oversee all aspects of projects. Set deadlines, assign
responsibilities and monitor and summarize progress of
project.
- The successful candidate will work directly with stakeholders
to ensure deliverables fall within the applicable scope and
budget.
- He or she will coordinate with other departments including but
not limited to Regulatory, Quality and Supply Chain.
- Candidate should have a bachelor's degree and 2-4 years of
experience as a project manager in a health care products field or
in a related area.
- Rely on limited experience and judgment to plan and accomplish
goals.
- Perform a variety of tasks. Lead and direct the work of others.
Will work under guidance from Associate Director of On-Market
Regulatory.
- Enhance department and organization reputation by accepting
ownership for accomplishing new and different requests;
- exploring opportunities to add value to job
accomplishments.
- Prepare reports for upper management regarding status of
project.
Responsibilities:
- Coordinate internal resources and third parties/vendors for the
flawless execution of projects
- Review and prepare regulatory documentation for various
submissions with the regulatory bodies and Affiliates
- Review Technical files and approve documentation as
needed.
- Collaborate with Country Affiliates to coordinate the
submission activities and ensure that they are completed as per
timelines
- -Work with the project team to track and mange submission
activities
- Ensure that the project is completed on-time, within scope and
within budget
- Assist in the definition of project scope and objectives,
involving all relevant stakeholders and ensuring technical
feasibility
- Ensure resource availability and allocation
- Develop a detailed project plan to monitor and track
progress
- Manage changes to the project scope, project schedule and
project costs using appropriate verification techniques
- Measure project performance using appropriate tools and
techniques (should have familiarity with Microsoft project or
similar project management software)
- Report and escalate appropriate issues to management as
needed
- Manage the relationship with all stakeholders
- Perform risk management to minimize project risks
- Create and maintain comprehensive project
documentation
- Track project performance, specifically to analyze the
successful completion of short and long-term goals
- Meet budgetary objectives and make recommendations for
adjustments to project constraints based on financial
analysis
- Develop comprehensive project plans to be shared with clients
as well as other staff members
- Perform other related duties as assigned
- Develop spreadsheets, diagrams and process maps to document
needs
Requirements:
- Proven working experience in project management
- Excellent internal communication skills
- Excellent written and verbal communication skills
- Solid organizational skills including attention to detail and
multitasking skills
- Strong working knowledge of Microsoft Office (including
Microsoft Project)
- Project Management Professional (PMP) or similar certification
is a plus
- Bachelor's Degree in appropriate field of study or equivalent
work experience
- Strong knowledge and understanding of FDA's, MHRA'S, USFDA
organization and EU and its regulatory compliance
processes.
- Knowledge of European regulations for medical devices, new EU
MDR and MDD, IVDR.
Project Manager top skills & proficiencies:
- Developing and Tracking Budgets
- Supervision without direct reports
- Project Management
- Process Improvement
- Planning
- Performance Management
- Inventory Control
- Verbal Communication
- Proficient in Microsoft Project, Microsoft Excel, Microsoft
Word and SharePoint
Keywords: Horizontal Talent, Des Plaines , Project Manager, Executive , Des Plaines, Illinois
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