Jobs at Venesco, LLC

Lead regulatory strategy and FDA interactions for medical products. Prepare and review INDs/NDAs/BLAs/IDEs/510(k)s, assess regulatory risk, maintain product profiles, mentor junior staff, and drive SOP/process improvements to ensure compliance throughout the product lifecycle.

Develop and validate SAS programs to produce TLFs, generate SDTM/ADaM/SEND datasets, create define.xml and reviewer guides, support interim/final analyses and FDA submission packages, and maintain documentation and standards while collaborating with Clinical Data Management and Biostatistics.

Provide statistical leadership for clinical and nonclinical studies by developing SAPs and methodologies, designing studies and sample size calculations, reviewing protocols/CRFs, interpreting outputs, supporting FDA meetings and regulatory submissions, mentoring junior staff, and participating in cross-functional program reviews.

Provide medical oversight for pharmacovigilance: review and assess serious adverse events, perform causality and expectedness assessments, lead signal detection and benefit-risk evaluations, support regulatory reporting and inspections, contribute to safety documents (IND, DSUR), and advise project teams and safety committees.

Lead design, development, testing, validation, implementation, and maintenance of FDA-regulated clinical trial EDC databases. Create CDASH CRFs, implement edit checks and derivations, perform UAT and validation, manage change control, generate data extracts/reports, support database lock, and ensure CDISC/SDTM and regulatory compliance for submission-ready datasets.

Perform site qualification, initiation, monitoring, and closeout visits; conduct source data verification, review informed consent and regulatory binders, evaluate protocol compliance, generate monitoring reports, support site training, CAPA tracking, audit/inspection readiness, and maintain study documentation.

Lead and oversee FDA-regulated clinical studies across startup, conduct, and closeout. Manage project plans, TMF, protocol documentation, stakeholder coordination, ClinicalTrials.gov reporting, study metrics, risk mitigation, and support inspections and audits.

Support CMC, quality, manufacturing, and nonclinical activities across product lifecycle: review specs, validations, stability, audits, regulatory CMC content, manufacturing risks, and logistics.

Support pharmacovigilance by triaging and processing adverse event reports, maintaining safety databases and documentation, reconciling clinical and safety data, assisting regulatory (MedWatch) submissions, DSMB logistics, safety trend analysis, and study closeout activities to ensure inspection-ready records.

Integrate, analyze, and interpret data from surveillance, clinical, and operational health systems to support public health decision-making, biosurveillance, and Air Force mission readiness. Apply epidemiology, biostatistics, and research methods to design studies, model outcomes, submit IRB protocols, and provide actionable intelligence to military leaders and public health professionals.

Design, develop, implement, and evaluate instructional programs, eLearning, multimedia, and training materials using ADDIE and instructional design best practices to support Air Force education and training missions.

Design and build dashboards and visualizations from integrated health, surveillance, and operational datasets to inform Air Force public health decision-makers. Perform data preparation, cleansing, modeling, analysis, and communicate insights to senior leaders while ensuring HIPAA-compliant handling of sensitive health information.

The Senior Administrative Services Manager oversees IRB operations, ensuring compliance, managing submissions, and mentoring junior staff in research settings.

The DADMS Analyst manages software/hardware registration, ensures compliance with IT portfolio management, prepares reports, and coordinates with program offices and engineers.

Lead scientific research projects, provide strategic recommendations, support initiatives in partner countries, and analyze emerging technologies.

Provides advanced engineering expertise and leadership in project planning, design, and technical problem solving. Guides junior engineers and supports complex engineering projects.

Oversee clinical trial operations, ensure safety surveillance, manage documentation, and collaborate with teams on regulatory submissions.

Delivers advanced training programs and supports curriculum development in complex technical or scientific fields.

The role involves supporting behavioral science research through study development, statistical analysis, technical reporting, and consultation, focusing on human performance for the Air Force.

The Scientist I conducts technical assessments, research analysis, provides advisory support, collaborates with stakeholders, and develops complex problem solutions.