Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp Email and Phone Number
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"When life gives you lemons, throw grapefruit back! They make a bigger splat!"Life doesn't go as expected. When faced with a life changing or threatening medical diagnosis, we pray treatment or therapy (drug or medical device) is available to fight it. My passion comes from being that person and recognizing we still have so much to do to help all. Whether it's making quality systems robust, running a trial or preparing reg documents, I champion it. If it needs to get done, I'm there with an optimistic and excited outlook.As a versatile Clinical Researcher with experience in Regulatory Affairs and Quality Systems, I'm known as a: DYNAMIC, RESOURCEFUL PROBLEM SOLVER✔ Thrives on challenge with ability to change focus quickly, engages a team and provides ethical, high quality solutions✔ Comes up to speed quickly on complex clinical or regulatory issues (FDA,ISO,MDD), confronts project with a fearless approach✔ Develops innovative ideas in a creative yet logical framework delivering long-term solutions to short-term problemsCATALYST OF CHANGE✔ Not afraid to tackle anything, can see a task through regardless of what it takes using a “Can do”, energetic multi-tasking attitude✔ Achieves results through a collaborative approach, maintains a client focus with high attention to detail and taking decisive action✔ Tells people what they need to know, engages them in the change and creates trust to nurture desired outcomesCOMPELLING COMMUNICATOR, INSPIRING RELATIONSHIP BUILDER✔ Puts together compelling and convincing arguments to motivate and influence✔ Instills confidence by listening thoughtfully and communicating clearly especially during times of adversity, uses please and thank you✔ Fosters relationships between stakeholders, CROs, sites or sponsors using a combination of responsiveness, passion and curiosity✔ Careful and concise writer/editor producing easy-to-read/use study (Protocol,CRF), regulatory (CRBA,CER) and clinical quality (SOP,Audit) documents
Insightec
View- Website:
- insightec.com
- Employees:
- 496
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Director Of Clinical AffairsInsightecMinneapolis, Mn, Us
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Director Of Clinical And Regulatory AffairsAgitated Solutions Inc Feb 2024 - PresentSt Paul, Minnesota, Us -
Director Of Clinical AffairsInsightec Feb 2022 - Dec 2023Tirat Carmel, Haifa, Il• Leadership and dynamic resource management of global clinical affairs team for non-invasive neurosurgery clinical trials (USA, Canada, Europe, Israel, Asia) with MRI Guided Focused Ultrasound• Orchestration of approximately 40 trials including feasibility, pivotal (IDE) and post-market medical device and pharmaceutical (IND) clinical studies in adults and pediatrics
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Principal Product Development Strategist- Clinical/Program DirectorNamsa Jan 2021 - Feb 2022Toledo, Oh, Us -
Principal Clinical Study ManagerNamsa Jul 2018 - Feb 2022Toledo, Oh, Us
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Director Of Clinical, Regulatory, Quality And EngineeringFrestedt Incorporated Nov 2017 - Apr 2018UsComprehensive and Strategic Consulting Services including Regulatory Affairs (strategies, submissions, and discussions), Clinical Affairs (strategies, protocols, data analyses, CRO and KOL management), and Quality Systems (SOP strategy, documentation, audits) -
Director, Clinical, Quality And Regulatory AffairsMagellan Medical Technology Consultants, Inc. Feb 2015 - Nov 2017Minneapolis, Minnesota, UsMagellan Medical Technology Consultants is a company of medical technology and healthcare experts valued for being accessible, responsive and enthusiastic partners in creating and implementing powerful solutions for complex med tech and healthcare challenges with the expertise of five integrated business units: Market Access Now, Clinical Research Organization, National Field Teams, Reimbursement Solutions, and Regulatory Compliance. -
Business Strategist, PresidentBig Bad Wolfe Strategies Oct 2008 - Feb 2015Specializing in assisting companies to create a solid foundation by developing organizational strategies and operational efficiencies to achieve their future goals. ～ Organizational Efficiencies～ Operational and Process Streamlining～ Strategic Planning and Solutions～ Market Assessment and Competitive Analysis～ Financial Analysis～ Technical Writing
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Clinical Research, Clinical Quality And Regulatory Affairs | Project Manager | Consultant | CraFrestedt Incorporated Oct 2008 - Feb 2015UsManaged strategic projects within a virtual CRO for client companies (sponsor and site) of clinical research, regulatory affairs and quality systems
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Executive Director (Interim)Shamblott Family Dentistry Mar 2013 - Jun 2014UsDeveloped a comprehensive strategic plan to improve the patient experience, employee job satisfaction and overall operating efficiencies as well as increase revenues, number of new patients and referrals -
Clinic AdministratorSound Sleep Centers Oct 2008 - Oct 2010Maple Grove, Minnesota, Us -
Adjunct FacultyUniversity Of Phoenix 2006 - 2009Phoenix, Az, Us -
Business ManagerOn Call Clincians Jan 2006 - Oct 2008Minneapolis, Mn, Us -
Account ManagerOn Assignment Lab Support 2002 - 2005Glen Allen, Va, Us -
Project Manager/Development ScientistBasf Apr 1998 - Apr 2000Ludwigshafen, De -
Quality Assurance Specialist- Medical TextilesMedline Industries Jul 1996 - Apr 1998Northfield, Il, UsQuality Assurance Management of 77,000 Class 1 and 2 Medical Products
Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp Skills
Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp Education Details
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University Of Minnesota - Carlson School Of ManagementStrategic Management And Entrepreneurship -
University Of ManitobaChemistry
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Clemson UniversityPolymer/Analytical/Textile Chemistry
Frequently Asked Questions about Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp
What company does Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp work for?
Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp works for Insightec
What is Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp's role at the current company?
Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp's current role is Director of Clinical Affairs.
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What schools did Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp attend?
Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp attended University Of Minnesota - Carlson School Of Management, University Of Manitoba, Clemson University.
What are some of Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp's interests?
Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp has interest in Children, Health.
What skills is Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp known for?
Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp has skills like Strategy, Medical Devices, Management, Clinical Trials, Project Management, Analysis, Clinical Research, Healthcare, Fda, Strategic Planning, Marketing, Regulatory Affairs.
Who are Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp's colleagues?
Pamela Wolfe, Mba, Ms, Ccrp, Acrp-Cp, Acrp-Mdp, Facrp's colleagues are Stephen Morio, Margarita Shimanovich, Bere N., Haya Zarko, Melissa Marin, Gosha Ganelis, Sarem-Aslani, Ali, Dr..
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