Global Regulatory Expert
6 days ago
We are seeking a seasoned Sr. Manager to provide regulatory support for our COVID-19 vaccine programs and be based in one of our East Coast hubs. This role involves managing INDs, marketing applications, and other regulatory submissions, as well as coordinating with global regulatory leads and project teams.
About the Job
- Develop and execute regulatory strategies through the product development lifecycle.
- Coordinate, develop, and contribute to content and format of regulatory submissions and related supplements and amendments.
- Identify and assess regulatory risks for assigned projects or programs.
- Serve as point of contact with regulatory agencies relevant to assigned projects or programs.
- BA/BS degree in a scientific/engineering/healthcare discipline required; Masters, PharmD or PhD preferred.
- 5+ years of experience in the Pharmaceutical industry preferred.
- 3+ years of experience in Regulatory strategy or relevant training/experience preferred.
- Strong knowledge of current US and EU regulations.
- Experience with CTD format and content of regulatory filings.
- Exceptional written and oral communication skills.
At Moderna, we are committed to building a culture of belonging and making a meaningful impact on society. We believe in giving our people a platform to change medicine and an opportunity to change the world. Our team is driven by a passion for innovation and a commitment to excellence.
We offer a competitive salary of $120,000 per year, plus benefits including medical, dental, and vision coverage options, flexible spending accounts, lifestyle spending account funds, family care benefits, and more. We also provide opportunities for professional growth and development, as well as a comprehensive suite of employee benefits.
Our company values diversity, equity, and inclusion, and we strive to create a work environment that is welcoming and inclusive for all employees. If you share our values and are passionate about making a difference in the lives of others, we encourage you to apply.
-
Bethesda, Maryland, United States Links Global Full timeJob OverviewLinks Global is seeking an experienced Data Driven Software and Database Solutions Expert to join our IT team. This role involves designing, developing, and maintaining high-quality software applications and database systems.ResponsibilitiesSoftware Development: Design, develop, test, and maintain software applications using programming languages...
-
Data Scientist
2 days ago
Bethesda, Maryland, United States Tenica Global Solutions Full timeTenica Global Solutions is seeking a highly skilled Data Scientist to join our team as a Senior Technical SETA (Science, Engineering, Technology, and Analysis) expert. In this role, you will leverage your expertise in quantitative social science, computer science, data science, or related disciplines to drive cutting-edge research and analysis.About the...
-
Global Logistics Operations Specialist
6 days ago
Bethesda, Maryland, United States Xometry Full timeXometry, a leading digital marketplace for manufacturing, is seeking an experienced Global Logistics Operations Specialist to join its fast-paced Logistics Department. This role will involve working with internal and external customers to coordinate international and domestic shipments.The ideal candidate will have a minimum of 3 years of experience in the...
-
Global Health Research Consultant
6 days ago
Bethesda, Maryland, United States Lifelancer Full timeJob Title: Global Health Research ConsultantEstimated Salary: $124,750 - $187,000 per yearLocation: Remote (United States)Job Type: Full-timeJob DescriptionWe are seeking a highly skilled Global Health Research Consultant to provide design, implementation, and analysis support to research projects related to socio-behavioral determinants of disease outcomes,...
-
Expert Financial Services Manager
6 days ago
Bethesda, Maryland, United States Fidelity TalentSource LLC Full timeFidelity TalentSource LLC is seeking a highly skilled Expert Financial Services Manager to join our team. This role offers an estimated salary of $80,000 - $110,000 per year.About the RoleWe are looking for a seasoned professional with at least five years of experience in financial sales and management. As an Expert Financial Services Manager, you will...
-
Medical Review Physician Expert
4 days ago
Bethesda, Maryland, United States Managed Care Advisors Full timeAt Managed Care Advisors, we are seeking a highly skilled Medical Review Physician Expert to join our team. As a Medical Review Physician Expert, you will play a crucial role in providing high-quality medical reviews and recommendations to support our clients' needs.About the Role:Conduct thorough medical assessments to determine program and benefit...
-
Bethesda, Maryland, United States General Dynamics Information Technology Full timeWe are seeking a highly skilled Cloud Security SME to join our team in Bethesda, MD. This is an exciting opportunity to make a personal impact and work on challenging projects.Globally trusted by governments and businesses alike, GDIT delivers mission-critical IT solutions and services that help clients achieve their goals. As a Cloud Security SME, you will...
-
Cybersecurity Expert
3 days ago
Bethesda, Maryland, United States General Dynamics Information Technology Full timeJob Summary:">This role offers an exciting opportunity to contribute to the success of our customer by providing cloud security expertise. As a Cybersecurity Expert, you will play a critical part in ensuring the confidentiality, integrity, and availability of sensitive information.">About Us:">General Dynamics Information Technology (GDIT) is a global...
-
Bethesda, Maryland, United States Precision Medicine Group Full timeAbout UsPrecision Medicine Group is a leading provider of health economics and outcomes research, global pricing, access strategy, and analytics services. Our team of experts delivers high-quality solutions to support our clients' success.Job SummaryWe are seeking an experienced Medical Research Expert with a focus on health economics to join our team. This...
-
Strategic Policy Expert
7 days ago
Bethesda, Maryland, United States Axle Full timeJob OverviewAxle is a pioneering bioscience and information technology company driving advancements in translational research, biomedical informatics, and data science applications nationwide and globally.Our team of experts in biomedical science, software engineering, and program management collaborates to develop and apply research tools and techniques...
-
Federal Contracting Manager
5 days ago
Bethesda, Maryland, United States Links Global Full timeJob Title: Federal Contracting ManagerSalary: $80,000 - $120,000 per yearAbout UsLinks Global is a leading provider of professional services to the federal government. We are committed to delivering high-quality solutions that meet the needs of our clients.Job DescriptionKey ResponsibilitiesManage the full life cycle of federal government contracts, from...
-
Cloud Security Expert, TS/SCI Clearance
6 days ago
Bethesda, Maryland, United States General Dynamics Information Technology Full timeAbout the RoleGeneral Dynamics Information Technology (GDIT) is seeking an experienced Cloud Security Expert to support our customer activities. As a key member of our team, you will help ensure today is safe and tomorrow is smarter.We are a global technology and professional services company that delivers consulting, technology, and mission services to...
-
Bethesda, Maryland, United States CohnReznick LLP Full timeAbout the RoleCohnReznick LLP is seeking an experienced International Tax Associate to join our team in one of our offices. As a key member, you will play a vital role in supporting our international tax department and contributing to the growth and success of our organization.
-
Network Automation Expert
7 days ago
Bethesda, Maryland, United States ARK Solutions, Inc. Full timeJob DescriptionWe are seeking an experienced Senior Network DevOps Engineer to join our team and help drive the adoption of network automation practices across all Global Network teams.
-
Bethesda, Maryland, United States Xometry Full timeJob DescriptionXometry is a leading digital marketplace connecting manufacturers with Fortune 1000 companies. As an International Logistics Coordinator, you will play a crucial role in our fast-paced Logistics Department.This position involves working with internal and external customers to quote and coordinate International and Domestic Shipments. Your...
-
Cloud Architect Lead
1 week ago
Bethesda, Maryland, United States NTT DATA, Inc. Full timeWe are seeking a seasoned Cloud Architect to lead the design and implementation of cloud solutions for a federal scientific research agency in the United States.About the RoleThis is a senior-level position requiring expertise in cloud architecture, security, and IT service management frameworks. The ideal candidate will possess a strong understanding of...
-
Bethesda, Maryland, United States NTT DATA Services Full timeAbout the JobWe are seeking a highly skilled Computer Systems Specialist to join our team in Bethesda, Maryland. The ideal candidate will have expertise in desktop support and be able to provide prompt, knowledgeable, and professional customer support to our customer base.ResponsibilitiesProvide technical support on software, hardware, and operating systems,...
-
Cloud Security Specialist
2 days ago
Bethesda, Maryland, United States NTT DATA Full timeCloud Security SpecialistWe are seeking an experienced Cloud Security Specialist to join our team in Bethesda, Maryland. This role involves managing cross-functional teams and ensuring the delivery of secure, scalable solutions for federal agencies.Job Description:The successful candidate will oversee the technical execution of cloud-based projects, ensuring...
-
Clinical Research Operations Specialist
1 week ago
Bethesda, Maryland, United States Guidehouse Full time**About the Role**A Clinical Research Operations Specialist is needed to provide clinical research regulatory support through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program.This role is centered around clinical research protocol and informed consent document development, requiring expert writing skills. The specialist will...
-
Bethesda, Maryland, United States MedVanta Full timeMedical Coding Auditor Job DescriptionMedVanta, the nation's largest physician-owned and operated next generation management services organization (MSO), is seeking a Medical Coding Auditor to join our team. As a key member of our Revenue Cycle Management team, you will play a vital role in ensuring the accuracy and compliance of our medical records.Key...