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Facility Management Director
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Director of Energy Managment
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Facility Management Director
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Stellar Enterprises New Richmond, WI, United States Freelance**Life Center Ottobeuren GmbH**: · At Sonnenbühl 3, 87724 Ottobeuren · Values and care go hand in hand for us. The **Argentum Group** is one of the leading providers of full-time care with over 40 locations and its own academy. We set standards for excellent care and as an employ ...
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Redpath & Company Saint Paul, United StatesJob Description · Job DescriptionSalary: · At Redpath and Company, our strength is our people. We believe in our employees, and offer a unique culture that promotes flexibility, creativity, and growth. As a rapidly growing mid size firm, we are the perfect size to be able to pr ...
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Director of Nursing Services Rn
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Theater Staging Specialist
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Vice President, Internal Audit
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Clinical Veterinarian
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Xenspire Technologies Twin Cities , MN, United StatesRAR is embarking on an exciting growth phase with development of and upgrades to existing facilities and expanding research into gnotobiotics and new non-human primate models. In light of this expansion, this position reflects an increase in the number of current clinical veterin ...
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Production Planner Manufacturing
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Port View Resources Ramsey, United StatesOur client, a** Ramsey, New Jerse **y manufacturer has an opening for a** Production Planner. **This is a full-time, permanent on-site position. · **Responsibilities**: · Liaise with Managing Director to promote continual improvement of the planning system. · Work with department ...
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Beyond The Canvas- Art Specialist I
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Mds Coordinator Rn
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Before And/or Afterschool Site Supervisor
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Metropolitan YMCA of the Oranges Maplewood, United StatesSign on bonus may apply · Are you ready to lead both children and staff? We're seeking leaders to help guide the future of our SACC program and our youth · Do you have talents to share, and want to make an impact on the lives of children? We're inviting people with passion and en ...
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Junior Camp Counselor
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Managing Director
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Managing Director
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Managing Director
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Business Management Specialist Media House
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Legal advisor as head of legal department
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Nexus Solutions Mendota, United StatesGermany's top address for IT company consulting is seeking reinforcements to support the young and dynamic team at the Nuremberg location. · The ASCON group advises and supports medium-sized clients for over 20 years , with approximately 20 employees, primarily from the IT ind ...
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Quantum Innovations Maplewood, United StatesOur client is a non-profit organization for youth welfare in Bremen and plans, operates, and constructs non-commercial facilities for leisure, education, and sports with a diverse and competent range of services for children and adolescents. Our client cooperates with schools in ...
Managing Director - Saint Paul, MN, United States - Parexel International
Description
As one of our ex-FDA colleagues describes it: "you get to see a lot of cool stuff very quickly".If you're looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there's no better place to be than as a Vice President, Technical on Parexel's Regulatory Strategy team (RS) As a VP, Tech you'll work on a variety of assignments, diverse product types for clients with wide-ranging geographical considerations while enjoying fantastic career opportunities and work/life balance all while working from home.
As a critical member of Parexel's Regulatory Strategy team, you'll be creating opportunity for clients throughout the product lifecycle.
Sharing your scientific, technical, regulatory and/or commercial expertise with them, so that they can bring better, safer products to market, in line with regulators' requirements.
You'll be working at a senior / strategic level, and leading teams of respected SMEs in supplying the answers.
We're currently seeking a highly experienced Clinical Regulatory Leader, Health Authority Medical Review Team Lead, Master/Senior Medical Review Officer who is looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy teamA Technical Vice President must be an internationally recognized professional in their field of expertise with fully proven rainmaking skills and relationships at the most senior levels within client organizations.
Project ExecutionWorks within a team environment or individually based on the project needs
Works within broad project guidelines and leads issue and conflict resolutions
Prioritizes own workload and prioritizes the workload of the project team to achieve the project scope and objectives
Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action
Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
Produces quality work that meets the expectations of RS and the client. Reviews the work of colleagues for content and quality to ensure the expectations of the client and RS are met
Manages project engagements (small or large)
Interacts with the assigned Project Assistant to ensure accurate financial management and for general project support
Provides guidance to project team members and acts as a mentor to junior staff
Frequently presents speeches or seminars to industry groups based on recognized expertise in his/her field
Reviews the thought leadership activities (presentations, articles) of colleagues for content and quality to ensure the expectations of RS are met
Regularly quoted by general and industry news outlets
Contributes expertise to professional societies, academic or other similar groups influential in his/ her area of expertise
Consulting Activities and Relationship Management
Provides a full range of technical and/or business consulting services across multiple disciplines of services including representing clients to regulatory agencies
Completes and delegates project activities in a timely manner with an understanding of issues which may impact project profitability and client satisfaction
Acts as a loaned executive for a client when required
Facilitates resolutions to possible problems or conflicts within the project team and/or the client
Provides guidance as needed to lower-level colleagues on appropriate methods of executing project activities
Demonstrated ability to interact professionally at multiple levels including senior and executive management within a client organization. Identifies opportunities for follow-on business or changes in project scope and exploits the opportunities with RS management and account management
Education - MD or PhD required
Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in Clinical Development/Clinical Trial Design, Clinical Strategy, and authoring clinical sections of regulatory applications.
Previous experience with a regulatory agency (such as the FDA or MHRA) as a Senior / Master Medical Review Officer, Team Lead, etc.
or a related Medical role ie. Extensive Oncology experience is required.The ability to travel up to 20-30% domestically and/or internationally may be required for Client and/or Health Authority Meetings and Thought Leadership/Conference Attendance
Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.
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