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228 results found
November 30, 2022
Clinical
Novavax HQ, Gaithersburg, Maryland, USA; Remote - US, USA
The Senior Manager, Global Vaccine Safety (GVS) Compliance is responsible for managing and/or leading Pharmacovigilance (PV) quality and compliance activities. These activities may include but are not limited to PV Compliance oversight, audit/inspection readiness, Pharmacovigilance System Master File (PSMF) management, CAPA management, Deviation management, PV business partner agreements and oversight, PV Intelligence, PV Standard Operating Procedure (SOP) management and operational excellence, PV training and knowledge management, business continuity, and oversight of compliance monitoring activities related to regulatory reporting timelines and Key Performance Indicators (KPIs) for internal PV related activities, service provider/vendor activities, and overall PV system performance.
November 30, 2022
Clinical
Novavax HQ, Gaithersburg, Maryland, USA; Remote - US, USA; Remote Maryland, Gaithersburg, Maryland, USA
The Associate Director, Global Vaccine Safety (GVS) Compliance is responsible for leading and oversight of Pharmacovigilance (PV) quality and compliance activities. These activities may include but are not limited to PV Compliance oversight, audit/inspection readiness, Pharmacovigilance System Master File (PSMF) management, CAPA management, Deviation Management, PV business partner agreements and oversight, PV Intelligence, PV Standard Operating Procedure (SOP) management and operational excellence, PV training and knowledge management, business continuity, as well as oversight of compliance monitoring related to regulatory reporting timelines and Key Performance Indicators (KPIs) for internal PV related activities service provider/vendor activities and overall PV system performance.
November 28, 2022
Finance / Accounting
Novavax HQ, Gaithersburg, Maryland, USA
We are seeking an Associate Director, Commercial Finance to join the team located in Gaithersburg, MD. As a leader within our Commercial Finance team, you will report to the Senior Director, Commercial Finance. This role provides management and leadership to the commercial finance team associated with financial consolidation efforts, strategic decision support, forecasting, and month end close activities for global commercial functions and related operating expenses.
November 23, 2022
Regulatory Affairs
Remote - US, USA
We are seeking an Associate Director, Global Regulatory Affairs (GRA) Business Operations. The functions include but not limited to: Regulatory Development and Operations, Regulatory Clinical, Global labeling, Regulatory CMC, Regulatory Information Management and Publishing, Advertising and Promotion Compliance. This role will be responsible for assuring the GRA functional and cross-functional business practices are efficient, compliant with SOPs, establish best practices and drive process improvements.
November 23, 2022
Quality Control
Novavax HQ, Gaithersburg, Maryland, USA
We are seeking a Quality Specialist I to join our Quality Assurance as batch release and project coordinator in Gaithersburg, MD. The specialist will be responsible for support of GMP compliance with a focus on project coordination between the various QA/QC groups. The candidate will provide project coordination support, ensure organizational alignment of the QA/QC teams, and ensure all documents and the data is accurate, provide status update on all on going projects and programs. This position will require periodic weekend/evening work and travel.
November 22, 2022
Supply Chain
Novavax HQ, Gaithersburg, Maryland, USA
Working with the Manager of Production Planning & Coordination you will define and lead the production planning processes for the organization. As a planning professional, you will partner with internal stakeholders as well as a CMO network to drive clarity in execution across the end-to-end supply chain. You will be an integral member of the Operations Team and expected to develop and deliver best-in-class production planning capabilities.
November 22, 2022
Marketing
Remote - US, USA
The Associate Director of Advocacy develops relationships with third-party organizations and key influencers to advance Novavax’ mission, pipeline, science and leadership within the assigned US Region.
November 22, 2022
Legal - Regulatory Compliance
Remote - US, USA; Novavax HQ, Gaithersburg, Maryland, USA
We are seeking a North American Regional Compliance Officer to lead, drive and manage all aspects of Novavax global compliance operations in North America. Reporting directly to the VP, Global Compliance, this position will be responsible for developing strategic direction, compliance guidance, training, as well as implementing and maintaining all aspects of compliance in North America. This position will serve as a critical and valued member of the Compliance and Legal team and will partner with other key stakeholders in the business by providing business-oriented and pragmatic guidance that enables the company to achieve its compliance obligations, purpose, and goals within North America.
November 21, 2022
Process Development and Manufacturing
Novavax HQ, Gaithersburg, Maryland, USA
We are seeking an Associate Scientist to join our Downstream Process Development Department – Early Stage in Gaithersburg, MD. Qualified individuals will play a leading role on downstream process development; scale up, and technical support of cGMP manufacturing for proteins, nanoparticles and virus-like particle (VLP) based vaccines. The candidate will ensure scientifically sound design and scalable purification processes are created. The candidate will also be responsible for generating materials for pre-clinical studies and other development purposes. The candidate is expected to be highly self-motivated, well organized, and very productive. This position will be located at our Gaithersburg, MD facility and will report to a Scientist in Downstream Process Development.
November 21, 2022
Research & Development
DO NOT USE, Gaithersburg, Maryland, USA
The Biorepository Technician is responsible for acquiring the skills to do the receipt, inventory, storage, withdrawal and shipment of biological samples, clinical agents, and materials from multiple clients. These materials may be stored at temperatures below freezing with potentially hazardous properties.