Global Regulatory CMC Manager
4 weeks ago
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.Responsible for the global regulatory evaluation of CMC change controls with supervision.Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.Requirements: BS/BA degree in Scientific Discipline (Masters or higher preferred) with - years in the pharmaceutical industry, preferably with - years CMC regulatory experience.Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
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Scientific - Global Regulatory CMC Manager
2 months ago
Akron, Ohio, United States Net2Source Inc Full timeWe believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.Participate...
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Senior Principal Scientist
3 weeks ago
Akron, Ohio, United States Bristol-Myers Squibb Full timeSenior Principal ScientistApply locations Summit West - NJ - US New Brunswick - NJ - US time type Full time posted on Posted 16 Days Ago job requisition id R1582246Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely...
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Senior Principal Scientist
4 weeks ago
Akron, Ohio, United States Bristol-Myers Squibb Full timeSenior Principal Scientist page is loaded Senior Principal Scientist Apply locations Summit West - NJ - US New Brunswick - NJ - US time type Full time posted on Posted 16 Days Ago job requisition id R Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is...
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Global Supply Chain Program Manager
2 weeks ago
Akron, Ohio, United States Sunrise Systems Full timeJob Title: Supply Chain Project ManagerCompany: Sunrise SystemsPosition Summary:We are excited to present a remarkable opportunity for a Supply Chain Project Manager at Sunrise Systems. This role is designed for individuals who are eager to engage in the realm of Supply Chain Strategy and Business Operations. You will be responsible for steering critical...
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Global Supply Chain Program Manager
2 weeks ago
Akron, Ohio, United States Sunrise Systems Full timeJob Title: Supply Chain Project ManagerCompany: Sunrise SystemsPosition Overview:Are you prepared to engage in the dynamic field of Supply Chain Strategy and Operational Excellence? Sunrise Systems is seeking a Supply Chain Project Manager to spearhead critical initiatives that enhance our global supply chain processes. This position offers the opportunity...
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Global Customer Service Operations Manager
6 days ago
Akron, Ohio, United States Continental Full timeJob DescriptionJob Summary:We are seeking a highly skilled and experienced Global Customer Service Operations Manager to join our team at Continental. As a key member of our customer service team, you will be responsible for managing the day-to-day operational import/export activities for ContiTech USA and ContiTech Canada.Key Responsibilities:Manage a team...
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Lead Engagement Manager
2 weeks ago
Akron, Ohio, United States Insight Global Full timeInsight Global is seeking a Lead Engagement Manager to operate in a hybrid work environment for one of our prominent clients. This role entails overseeing various attest engagements, ensuring a seamless process from initiation to completion, while also conducting technical research. The individual will manage a team of 1-3 attesting agents, with a focus on...
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Global Supply Chain Manager
6 days ago
Akron, Ohio, United States Sunrise Systems Full timeJob Title: Supply Chain Project ManagerJob Summary:We are seeking a highly skilled Supply Chain Project Manager to join our team at Sunrise Systems. As a key member of our Global Supply Chain Strategy & Business Operations team, you will be responsible for leading the planning and execution of high-priority and complex supply chain projects and/or...
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Senior Compliance Officer
2 weeks ago
Akron, Ohio, United States Summa Health Full timeJob Summary:The Senior Compliance Officer is a critical role within Summa Health, responsible for ensuring the organization's compliance with laws, regulations, and policies. This position requires a strong understanding of regulatory requirements and the ability to collaborate with various departments to maintain a culture of compliance.Key...
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Global Mobility Lead
2 months ago
Akron, Ohio, United States Goodyear Full timeLocation: Akron, OH (Hybrid)Sponsorship Available: No Relocation Assistance Available: No Goodyear. More Driven. Position Description:A critical member of the Total Rewards team that will provide subject-matter expertise to the business regarding all expatriate matters for Goodyear's assignees. This includes complete assignment life-cycle management for...
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Senior Project Manager
1 month ago
Akron, Ohio, United States Innova Solutions Full timeInnova Solutions is immediately hiring for an Senior Project ManagerJob Title: Senior Project ManagerLocation: Summit, NJ (Hybrid)Duration: 12 MonthsPay Range*: $81 - $82 per hour. As a(n) Senior Project Manager you will:Job Description: Apply project management expertise across the portfolio for both standard and complex projects, managing multiple projects...
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Global Infrastructure Engineer
2 weeks ago
Akron, Ohio, United States Goodyear Full timePosition Overview:We are seeking a skilled Facilities Engineer to become a vital member of our Global Engineering division at Goodyear. In this role, you will be tasked with the design and specification of equipment and utility systems aimed at enhancing facility operations, renovations, expansions, or new construction initiatives. Your engineering expertise...
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Helicopter Pilot
5 days ago
Akron, Ohio, United States Global Medical Response Inc Full timeJob SummaryWe are seeking a highly skilled Helicopter Pilot to join our team at Global Medical Response Inc. As a Helicopter Pilot, you will be responsible for safely transporting patients to medical facilities, working closely with medical experts to ensure the highest level of care.Key ResponsibilitiesAircraft Operations: Ensure aircraft readiness for...
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Helicopter Pilot
10 hours ago
Akron, Ohio, United States Global Medical Response Inc Full timeJob SummaryWe are seeking a highly skilled Helicopter Pilot to join our team at Global Medical Response Inc. As a Helicopter Pilot, you will be responsible for safely transporting patients to medical facilities, working closely with medical experts to ensure the highest level of care.Key ResponsibilitiesAircraft Operations: Ensure aircraft readiness for...
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Senior Analyst of Global Transportation
2 weeks ago
Akron, Ohio, United States Goodyear Full timeSenior International Transportation AnalystLocation: Akron, OH, USCompany: GoodyearPrimary Purpose of the Position:Oversee and optimize an international transportation budget exceeding $100 million, focusing on ocean, air, and drayage logistics. Formulate strategies to achieve and surpass annual operational objectives.Direct and enhance the continuous...
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Aviation Medical Transport Pilot
1 week ago
Akron, Ohio, United States Global Medical Response Inc Full timeJoin Our Team as a Helicopter Pilot If you have a passion for aviation and thrive in a fast-paced environment, we invite you to explore an exciting opportunity with us. We are seeking a dedicated Helicopter Pilot to deliver essential medical air transportation services to our clients. Safety is a fundamental aspect of our operations. Compensation Package:...
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Civil CAD Designer
2 days ago
Akron, Ohio, United States Insight Global Full timeJob Summary:Insight Global is seeking a skilled Civil CAD Technician to join their team in a technical role. The successful candidate will be responsible for creating and revising technical drawings associated with civil site design and engineering.Key Responsibilities:Collaborate with designers, engineers, and project managers to execute project...
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ER Nurse
2 days ago
Akron, Ohio, United States Capleo Global Full timeJob Title: ER NurseJob Summary:We are seeking a highly skilled and experienced ER Nurse to join our team at Capleo Global. As an ER Nurse, you will be responsible for providing high-quality patient care in a fast-paced emergency room environment.Responsibilities:Provide direct patient care: Assess, diagnose, and treat patients in the emergency room...
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Akron, Ohio, United States Goodyear Full timeAbout GoodyearGoodyear is a leading tire company with a global presence, employing approximately 72,000 people across 23 countries. Our two Innovation Centers in Akron, Ohio, and Colmar-Berg, Luxembourg, drive the development of cutting-edge products and services that set industry standards. We value diversity and strive to create a safe and inclusive work...
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ER Nurse
6 days ago
Akron, Ohio, United States CapLeo Global Full timeJob Title: ER NurseJob Summary:We are seeking a highly skilled and experienced ER Nurse to join our team at CapLeo Global. As an ER Nurse, you will be responsible for providing high-quality patient care in a fast-paced emergency room environment.Responsibilities:Provide direct patient care: Assess, diagnose, and treat patients in the emergency room...