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Conduct Project Management activities to deliver quality, efficiency, and timely solutions to clients Plan, develop, monitor, and track project schedules through an integrated project management system across clients and concurrent projects Manage budget and deliverables timelines throughout the project lifecycle Manage the departmental project portfolio to meet evolving deadlines by balancing and
Posted 1 day ago
Certara USA, Inc.
- Seattle, WA / Wilmington, DE / San Diego, CA / 6 more...
Strategic Planning Drive the development of significant change programs that have wide ranging implications and goals Monitor the evolving medical device regulatory environment and changes to provide strategic input to ensure our market position is maintained Provide leadership during the implementation of the corporate framework within Synchrogenix Thought Leadership Serve as a medical device Sub
Posted 2 days ago
Strategic Planning • Provide input on significant change programs that have wide ranging implications and goals • Monitor regulatory environment and changes to provide strategic input to ensure our market position is maintained • Support the implementation of the corporate framework within Synchrogenix Thought Leadership • Serve as a Subject Matter Expert and represent Synchrog
Posted 1 day ago
Certara USA, Inc.
- New Haven, CT / Wilmington, DE / Princeton, NJ / 3 more...
Operations Assure efficient and profitable performance of our suite of analytic services creating a sustainable and scalable resource for EvA as well as broader Certara organization. Assure efficient cross resourcing and collaboration with other EvA and Certara wide teams on multidisciplinary and global projects and programs Support Business Development as needed, including client account manageme
Posted 1 day ago
Certara USA, Inc.
- New Haven, CT / Wilmington, DE / San Diego, CA / 16 more...
Our Pharmacometricians are responsible for supporting quantitative decision making in drug development through the development and application of population PK, PK/PD, exposure response and other models. Qualified candidates will have the ability to work on a variety of therapeutic indications and data types and must be experts in applied Population PK, PK/PD, and/or exposure response modelling an
Posted 3 days ago
In this role you will play a pivotal part in supporting and leading client early and late clinical development engagements by providing scientific and strategic pharmacometrics input that addresses key questions in their development programs, clinical study design considerations, model informed drug development strategies, as well as interactions with and submissions to regulatory authorities. Add
Posted 1 day ago
Certara USA, Inc.
- Orlando, FL / Wilmington, DE / San Diego, CA / 4 more...
Lead or participate in a project team which may be led by a Principal Regulatory Writer or Associate Principal Regulatory Writer Author documents per client specifications, templates, style guides, and other guidance documents Author documents per regulatory authority guidelines and requirements Act as client advisor, working with all parties to lead development of strategies for organizing and pr
Posted 1 day ago
Under supervision of senior analyst/manager, implement wide range of data analyses by using R or SAS. Data analyses may include regression analyses, survival analyses, parametric and non parametric testing, data visualization, simulations etc. Contribute to the drafting of statistical analysis plans and statistical reports under the supervision of senior analyst/manager. Support development of goo
Posted 3 days ago
Certara USA, Inc.
- New Haven, CT / Wilmington, DE / San Diego, CA / 7 more...
#LI JS1 #LI TE1 Certara is looking for talented and motivated Sr. PBPK Consultants that are eager to grow their career and join our team! This position can be based out of any Certara office or full time remote. Job Overview We have an immediate opening for a highly motivated and talented Senior PBPK Consultant and Scientific Advisor with a DMPK, PBPK and/or a biopharmaceutics modelling background
Posted 3 days ago
Certara USA, Inc.
- Parsippany, NJ / Wilmington, DE / San Diego, CA / 5 more...
Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents Lead a project team, actively participate in development and writing of high quality documents (study level and submission level documents, pharmacovigilance documents) Serve as liaison and subject matter expert internally and for clients, guiding
Posted 3 days ago
Lead and provide strategic insight on document quality related tasks including but not limited to quality control reviews using Word features/functions using internal/client templates/toolbars Liaise with KAMs document level publishing Proficiency in techniques to be able to offer services and proactively resolve issues to a client directly in more complex engagements (as a super user or client le
Posted 1 day ago
Certara USA, Inc.
- Gaithersburg, MD / Wilmington, DE / San Diego, CA / 5 more...
Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents Lead a project team, and actively participate in development and writing of high quality documents (study level and submission level documents, pharmacovigilance documents) Author documents per client specifications, templates, style guides, and o
Posted 3 days ago
Conduct Project Management activities to deliver quality, efficiency, and timely solutions to clients Plan, develop, monitor, and track project schedules through an integrated project management system across clients and concurrent projects Manage budget and deliverables timelines throughout the project lifecycle Manage the departmental project portfolio to meet evolving deadlines by balancing and
Posted 1 day ago
Independently implement/overview implementation of wide range of data analyses by using R or SAS. Data analyses may include regression analyses, survival analyses, parametric and non parametric testing, data visualization, simulations as well as advanced statistical methods such as propensity score matching, longitudinal data analyses, etc. Contribute to the drafting of statistical analysis plans
Posted 5 days ago
Certara USA, Inc.
- Raleigh, NC / Wilmington, DE / San Diego, CA / 1 more...
• Lead or participate in a project team which may be led by a Principal Regulatory Writer or Associate Principal Regulatory Writer • Author documents per client specifications, templates, style guides, and other guidance documents • Author documents per regulatory authority guidelines and requirements • Act as client advisor, working with all parties to lead development of stra
Posted 3 days ago
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