Hybrid preferred. Location NIL Deerfield or Round Lake
Project Manager
The Project Manager provides project leadership for high-visibility, highly complex compliance initiatives across multiple business units and functions around the globe.
This leader works closely with the program manager and project teams to define the business case, scope, schedule and resource plans.
This person is accountable to drive execution to the plans by monitoring and controlling all aspects of the work. She / he / they collaborates with the project leads and the program manager to define teams, milestones and help to resource the project accordingly.
Essential Responsibilities
- Provides project planning and leadership by implementing strategies and priorities based upon the overall program
- Provides clear direction on requirements to meet expectations of internal customers and business stakeholders
- Interacts with all functions and levels of management ensuring effective ongoing communication of priorities and progress updates in line with agreed plans across teams
- Accountable for core team performance and program schedule and execution
- Has visibility to capital projects related to the program and escalates delays and risks as needed
- Ensures identification and communication of project risks, development of risk plan and proactive management of risk response strategies
- Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes
- Maximizes business results through continuous improvement in organization's ability to execute programs from identification through implementation
- Work within the guidelines of project management, standard performance metrics, and regulatory guidelines to apply best practice Project Management skills and standards (such as PMBOK).
Qualifications :
- Minimum : Bachelor’s degree or equivalent, Operations, or related discipline plus years project management experience.
- Experience in a regulated industry such as pharmaceutical or medical manufacturing with a knowledge of GMP regulations.
- PMP (Project Management Professional) Certification preferred
- Self-motivated, team player, good interpersonal skills, and experienced in driving high performing teams.
- Strong leadership skills
- Proficient with Microsoft Project, Excel and PowerPoint
- Ability to operate in a virtual environment of various backgrounds and cultures as well as across time zones
- Respectful of individuals and the diverse contributions of all
USA - Program Manager Quality/Clinical/Regulatory Affairs Jr.
This leader works closely with the program manager and project teams to define the business case, scope, schedule and resource plans. She/he/they collaborates with the project leads and the program manager to define teams, milestones and help to resource the project accordingly. The Project Manager ...
Project Manager - Quality/Clinical/Regulatory Affairs Jr
This leader works closely with the program manager and project teams to define the business case, scope, schedule and resource plans. She/he/they collaborates with the project leads and the program manager to define teams, milestones and help to resource the project accordingly. Candidates are missi...
Manager, Regulatory Affairs
The Manager position in Regulatory Affairs contributes to the regulatory strategy for new and modified Sysmex medical device products. The Manager Regulatory Affairs is responsible for the preparation, documentation and submission of regulatory applications for Sysmex products. We currently have a g...
Future Opportunities - Join Our Talent Pipeline for Manager/Sr. Manager, Global Regulatory Affairs
Advise internal cross-functional team who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, & others such as Commercial. Responsible for operating in compliance with regulations, company policies, procedures, & guidance ...
Project Manager (Quality/Clinical/Regulatory Affairs)
Project Manager (Quality/Clinical/Regulatory Affairs). This leader works closely with the program manager and project teams to define the business case, scope, schedule and resource plans. She/he/they collaborates with the project leads and the program manager to define teams, milestones and help to...
Senior Manager, Regulatory Affairs, US & Canada (Hybrid Onsite)
Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy. Advise internal customers who may contribute to...
Senior Manager, Regulatory Affairs / Regulatory Affairs Leader
Are you ready to lead regulatory strategies that will have a global impact? Join my client as a Senior Manager in Regulatory Affairs, where you'll be at the forefront of innovation in the medical device industry. Manage and mentor a team of regulatory affairs professionals. Lead and shape regula...
USA - Regulatory Affairs Ops Specialist I
Title: Regulatory Affairs Ops Specialist I. Coordinate submission scheduling with regulatory publishing and ensures delivery of high-quality documents. Managing the preparation of regulatory submissions for IND, ANDA, NDA, K, Clientrom, and other electronic submission types. Creating timelines for r...
Sr. Manager- Regulatory Affairs
Leading and enabling strong cross-functional partnership between Regulatory Affairs and all key stakeholders including R&D, Marketing, Quality, Clinical Affairs, and other functions at all levels within the business, and the local Regulatory Affairs teams in the Philips international markets organiz...
Quality & Regulatory Manager - Medical Device/Equipment (Remote with travel)
Quality & Regulatory Manager - Medical Device/Equipment (Remote with travel). Quality and Regulatory Manager. Implement the worldwide Belimed Quality Policy and derive appropriate programs and systems to support strategic direction and conduct training on those systems. Analyze quality/regulatory in...