Project Manager
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Job Info

*Description:*




* The Regulatory Project Manager will manage the execution of the 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.

* Prepare reports for upper management regarding status 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.



*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