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Certara is hiring a Talent Acquisition Partner to support our Synchrogenix Regulatory Science Division! We will consider candidates that can work from our Wilmington, DE office or remotely with occasional travel. Company Overview Regulatory and Communications Strategy, Science, and Solutions As the largest consultancy of regulatory and medical writers in the industry, Synchrogenix is already a wel
Posted 1 day ago
T he Finance Associate is a key member of the finance team that works to support forecasting, budget vs. actual analysis, and KPI reporting. The Finance Associate is a key member of the finance team that works to support forecasting, budget vs. actual analysis, and KPI reporting. Responsibilities Gain proficiency in reporting functionalities across multiple systems Maintain data from multiple syst
Posted 1 day ago
Certara USA, Inc.
- Wilmington, DE / San Diego, CA / Nashville, TN / 8 more...
Strategic Planning Identifies future directions in the ASR and T&D spaces and works with the Executive Leadership Team to establish business goals for the service line Understands industry dynamics and is able to internally communicate and facilitate changes and create long term solutions supporting evolution and growth. Thought Leadership Represents Synchrogenix ASR and T&D at conferences and in
Posted 1 day ago
Company Overview Regulatory and Communications Strategy, Science, and Solutions As the largest consultancy of regulatory and medical writers in the industry, Synchrogenix is already a well recognized, multi disciplined provider of regulatory writing, operations, and communications services. Additionally, our innovative technology platform, which includes both the ClinGenuity Artificial Intelligenc
Posted 1 day ago
Certara's pharmacometric drug development and informatics software portfolio is the most wide ranging in the industry and used across the drug development life cycle. Pharmacologists, toxicologists, biostatisticians, pre clinical scientists, chemists, geneticists and other scientists use our software to inform key safety and efficacy decisions, including target identification and optimization, fir
Posted 1 day ago
Certara's pharmacometric drug development and informatics software portfolio is the most wide ranging in the industry and used across the drug development life cycle. Pharmacologists, toxicologists, biostatisticians, pre clinical scientists, chemists, geneticists and other scientists use our software to inform key safety and efficacy decisions, including target identification and optimization, fir
Posted 1 day ago
Certara USA, Inc.
- Wilmington, DE / San Diego, CA / Nashville, TN / 9 more...
The Associate Director of Resource Management will be accountable for driving global resource assignments and capacity management to support and strengthen Synchrogenix position as a thought leader and a premium technology enable service provider in the industry. The Associate Director of Resource Management will serve as the primary Point of Contact (POC) for all resourcing decisions across the v
Posted 1 day ago
The Senior Director is accountable for oversight of a region to assure regional groups are sufficiently billable and profitable through maintenance of client relationships and writing of proposals. The Senior Director will be response for "selling integrated drug development offerings", act as a drug development lead and establish and lead a consulting business unit (CBU). The CBU Lead will play t
Posted 1 day ago
Certara USA, Inc.
- Wilmington, DE / San Diego, CA / Nashville, TN / 8 more...
Lead or participate in a project team which may be led by a Principal Regulatory Writer or Associate Principal Regulatory Writer, depending on document type or therapeutic experience Author documents per client specifications, templates, style guides, and other guidance documents Author documents per regulatory authority guidelines and requirements Act as a client point of contact Manage budget fo
Posted 1 day ago
Certara USA, Inc.
- Gaithersburg, MD / Wilmington, DE / San Diego, CA / 11 more...
Work closely with client, internal, and partner organization teams to lead development of strategies for organizing and preparing regulatory documents Lead a project team comprised of internal and client team members as well as partner organizations Serve as a liaison and subject matter expert for clients, guiding and advising them on strategies and best practices for achieving approval from regul
Posted 1 day ago
Certara USA, Inc.
- Gaithersburg, MD / Wilmington, DE / San Diego, CA / 11 more...
Associate Principal Regulatory Writers are critical members of our regulatory writing team. "APRWs" serve as lead authors, project leads and subject matter experts on complex regulatory documents. They also contribute to submission level documents and have the breadth and depth of experience and knowledge needed to guide our clients through the global regulatory landscape. Responsibilities Work cl
Posted 1 day ago
Certara USA, Inc.
- Wilmington, DE / San Diego, CA / Nashville, TN / 9 more...
The Regulatory Project Manager collaborates with the regulatory and submission leads for our regulatory consultation, document writing and submission level services. This individual will manage regulatory projects across multiple clients and work with internal project groups to advance agreed upon deliverables within budget and timelines. Has the capability of tracking milestones as well as helpin
Posted 1 day ago
The Talent Acquisition Coordinator will support the global recruitment strategy for Synchrogenix. This individual will need to have a high attention to detail, strong customer service and the ability to manage multiple priorities at once. Responsibilities Proactively develop, maintain, analyze and regularly deliver accurate reports Candidate pipelines, funnels, and forecasts Employee data Requisit
Posted 1 day ago
Certara USA, Inc.
- Wilmington, DE / San Diego, CA / Malvern, PA / 7 more...
Edit documents per client specifications, templates, style guides, and other guidance documents Edit documents per client and internal QC checklists. Create, manage, and maintain client document timelines and deliverable matrix Function as a client "super user," i.e., maintain and organize client specific guidance, templates, technologies, and preferences Act as a client point of contact Manage bu
Posted 1 day ago
As the Associate Director, Clinical Pharmacology, you will support the design, execution, and management of high quality clinical pharmacology, DMPK, and pharmacometrics studies. This position plays a pivotal role in assisting our Directors and Sr. Directors as they provide strategic clinical pharmacology guidance on drug development. Our team includes thought leaders who are among the most well r
Posted 1 day ago
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