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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 3 days ago
Demonstrate strong proficiency with quality control review, including verification of document against source, verification of internal consistency, verification of grammar based on understanding of grammar rules and begin to train others in this knowledge Expertly perform formatting techniques consistent with company guidelines, including but not limited to application of styles, table insertion,
Posted 3 days ago
Certara USA, Inc.
- Philadelphia, PA / San Diego, CA / Princeton, NJ / 2 more...
Associate may conduct any or multiple of the following activities in the areas of PK and data management PK Associate PK tasks such as NCA, entry level Modeling and Simulation, creation of TFL, authoring of CSR PK sections, ADA summaries. Performs noncompartmental analyses (NCA), creation of tables, figures and listings (TFL), authoring of pharmacokinetic (PK) sections in Clinical Study Report, Re
Posted 3 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
Certara USA, Inc.
- New Haven, CT / Princeton, NJ / Raleigh, NC / 3 more...
• Supports client projects from early nonclinical development activities through late stage development nonclinical and clinical pharmacology activities and quantitative analyses. • Identify additional support opportunities for client companies within and outside the Early Development group. • Collaborates with internal and client teams on regulatory, nonclinical development, clinic
Posted 4 days ago
include Accountable for oversight of a consultancy team to assure team members are sufficiently billable 80% of time in the office and profitable through maintenance of client relationships and writing of proposals. Billable consultant 60 80% Is part of the QSS US Leadership team together with the regional Senior Vice President (SVP) Accountable for organizational structure and operations of the c
Posted 5 days ago
Certara USA, Inc.
- New Haven, CT / Wilmington, DE / Princeton, NJ / 3 more...
Key duties and responsibilities include General Commercial/Market Analysis and Intelligence gathering Inputting, formatting, integrating, analyzing, and interpreting data to guide strategic commercial decisions Conducting examinations of commercial operations, performance, customer profiles and segment trends, industry impacts, and competition to improve optimize efficiency, profitability, and gro
Posted 5 days 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
The Associate Director Pharmacometrics will support client early and late clinical development engagements by providing pharmacometric evaluations that address 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. Responsibilities Conduct modeling analyse
Posted 5 days ago
• Conduct secondary research, including obtaining competitive intelligence, reviewing clinical studies, compiling information from research databases, analyzing sales information and market trends of life science products and services being evaluated • Develop discussion guides and survey tools for interviews with clinicians and health authorities • Recruit, or oversee the recruitme
Posted 5 days ago
Certara USA, Inc.
- Wilmington, DE / Princeton, NJ
Work as a billable consultant (~75% of "time in the office") on client projects. Consulting consists of a combination of hands on evaluations, as well as project scoping, analysis plan development, results interpretation, reporting and sharing with client teams. Depending on size of projects and depth of experience/knowledge, the Director, Biostatistics may provide project leadership to multiple
Posted 5 days ago
Certara USA, Inc.
- Cambridge, MA / Wilmington, DE / San Diego, CA / 1 more...
s • Remain knowledgeable of changes in the industry and adapting best practices Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on
Posted 6 days ago
The Director, Business Development will be responsible for identifying and pursuing strategic business with new and existing clients, understanding client business model and corporate objectives; understanding their development program focus, objectives and priorities; understanding their critical decisions and challenges and financial position; and evaluating and articulating how Simcyp’s c
Posted 6 days ago
Certara USA, Inc.
- Philadelphia, PA / San Diego, CA / Princeton, NJ / 3 more...
#LI TE1 Certara is looking for talented and motivated 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 Associate PBPK Consultant and Scientific Advisor with a DMPK, PBPK and/or a biopharmaceutics modelling background. The can
Posted 6 days ago
Our Pharmacometricians are responsible for providing expertise into clinical development plans, including the design, conduct, and interpretation of relevant clinical pharmacology and PK/PD studies. Qualified candidates will have the ability to work on a variety of therapeutic indications and data types with an adequate understanding of applied population PK and PK/PD modeling and simulation to su
Posted 6 days ago
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