Frederick County, Maryland, United States · On-site
Description Senior Regulatory Affairs Scientist Venesco LLC is seeking a Senior Regulatory Affairs Scientist to serve as a senior regulatory subject matter expert responsible for developing regulatory strategies, leading…
Skills: Regulatory Strategy, FDA Submissions, Risk Assessment, Target Product Profiles, Regulatory Intelligence
Frederick County, Maryland, United States · On-site
Description Pharmacovigilance Physician Venesco is seeking a Pharmacovigilance Physician to provide medical oversight and clinical expertise for all safety surveillance and pharmacovigilance activities. The physician is …
Skills: Pharmacovigilance, Medical Review, Causality Assessment, Safety Signal Evaluation, Benefit-Risk Analysis
Frederick County, Maryland, United States · On-site
$85k–$105k/yr
Description Medical Coder Venesco LLC is seeking a Medical Coder to perform clinical coding activities for adverse events, medical histories, procedures, and concomitant medications for FDA-regulated clinical trials, ens…
Skills: Medical Coding, MedDRA, WHO Drug Dictionary, Clinical Data Review, Coding Reconciliation
Frederick County, Maryland, United States · On-site
$125k–$150k/yr
Description Clinical Database Developer Venesco LLC is seeking a Clinical Database Developer to serve as the technical lead for the design, development, testing, validation, implementation, and maintenance of clinical tr…
Skills: Clinical Database Development, EDC Systems, CDASH, CDISC Standards, SDTM
Frederick County, Maryland, United States · On-site
$145k–$165k/yr
Description Senior Biostatistician Venesco LLC is seeking a Senior Biostatistician to provide statistical leadership for clinical and nonclinical studies by designing statistical methodologies, developing analysis plans,…
Skills: Statistical Analysis Plans, Study Design, Sample Size Calculation, Clinical Study Oversight, Regulatory Submissions
Frederick County, Maryland, United States · On-site
$135k–$148k/yr
Description SAS Programmer Venesco is seeking skilled SAS Programmers to develop validated statistical programs and CDISC-compliant datasets to support clinical trials, statistical analyses, safety reporting, and FDA sub…
Skills: SAS Programming, CDISC Standards, SDTM, ADaM, SEND
Frederick County, Maryland, United States · On-site
$85k–$95k/yr
Description Safety Surveillance Support Specialist Venesco LLC is seeking a Safety Surveillance Support Specialist to support pharmacovigilance and clinical safety activities by processing safety reports, monitoring adve…
Skills: Pharmacovigilance, Drug Safety, Adverse Event Reporting, MedWatch, Argus
Frederick County, Maryland, United States · On-site
$135k–$150k/yr
Description Product Technical Operations Scientist Venesco LLC is seeking Product Technical Operations Scientists to provide Chemistry, Manufacturing and Controls (CMC), investigational product, manufacturing, quality, a…
Skills: CMC, Pharmaceutical Development, FDA Regulatory Requirements, GMP, GLP
Frederick County, Maryland, United States · On-site
$125k–$143k/yr
Description Clinical Trial Manager Venesco LLC is seeking Clinical Trial Managers to provide leadership and operational oversight for FDA-regulated clinical studies, ensuring studies are executed in accordance with appro…
Skills: Clinical Trial Management, FDA Regulations, ICH-GCP, Project Planning, Trial Master File (TMF) Management
Frederick County, Maryland, United States · On-site
$100k–$110k/yr
Description Clinical Research Associate Venesco LLC is seeking a Clinical Research Associate (CRA) to provide clinical monitoring and oversight support to ensure studies are conducted in compliance with protocols, Good C…
Skills: Clinical Monitoring, Source Data Verification, Protocol Compliance, Regulatory Documentation, Site Qualification
Pensacola, Florida, United States · On-site
$19/hr–$24/hr
Description Venesco, LLC is hiring a Pharmacy Technician to provide services at Naval Hospital Pensacola and outlying clinics. Pharmacy Technicians will care for active-duty services members and their dependents. This is…
Skills: Pharmaceutical Dispensing, Prescription Filling, Drug Interaction Monitoring, Inventory Maintenance, Quality Improvement
Washington, District of Columbia, United States · On-site
$100k–$135k/yr
Description Senior International IT Procurement Expert Venesco LLC is seeking an International IT Procurement Expert for a Key Role on a proposal. Ideal candidates will have experience with national-scale IT procurements…
Skills: IT Procurement, Systems Integration, Bidding Document Development, Implementation Oversight, International Donor-Funded Projects
Beavercreek, Ohio, United States · On-site
$60k–$65k/yr
Description Public Health Instructor Venesco is seeking a Public Health professional to support the 711th Human Performance Wing at Wright-Patterson Air Force Base as a Public Health Instructor. US Citizenship is require…
Skills: Public Health Education, Instructional System Development, Classroom Instruction, Force Health Management, Community Health
Beavercreek, Ohio, United States · On-site
Description The Instructional Systems Designer (ISD) supports the Academic Development Branch by designing, developing, implementing, and evaluating instructional programs, eLearning content, multimedia products, and tra…
Skills: Instructional Design, ADDIE Methodology, eLearning Development, Adobe Captivate, SCORM
Beavercreek, Ohio, United States · On-site
Description The Data Visualization Specialist supports Public Health programs by transforming complex health, surveillance, and operational data into actionable visual insights for military leaders and decision-makers. T…
Skills: Data Visualization, Data Integration, Business Intelligence, Knowledge Management, Data Preparation
Beavercreek, Ohio, United States · On-site
Description The Epidemiologist supports Public Health operations by integrating, analyzing, and interpreting data from multiple surveillance, clinical, and operational health systems to improve public health decision-mak…
Skills: Epidemiology, Biostatistics, Public Health Research, Data Analytics, Knowledge Management
Pierce County, Washington, United States · On-site
$40/hr–$50/hr
Description Venesco, LLC is a premier government contractor providing Healthcare, IT, Research & Development and other services to government agencies. Venesco prioritizes employee connectedness and work life balance. Ve…
Skills: Chemistry, Urinalysis, Hematology, Serology, Bacteriology
Ward County, North Dakota, United States · On-site
$40/hr–$44/hr
Description MFLC Child, Youth, and Adult Behavioral Counselors Venesco LLC is looking for Military Family Licensed Counselors (MFLC) to support military members and families at/around Minot AFB in Minot, ND. We have an i…
Skills: Non-medical Counseling, Coaching, Training, Education, Stress Management
Beavercreek, Ohio, United States · On-site
Description Venesco, LLC., is seeking a Nurse Educator to assist on a contract with a federal government client in Dayton OH US Citizenship is required for this position. The contractor shall provide educational/training…
Skills: Curriculum Development, Clinical Training, Nursing Education, Critical Care Nursing, Emergency Room Management
Bandera, Texas, United States · On-site
$65k–$75k/yr
Description Quality Assurance Specialist Venesco, LLC is looking for a Quality Assurance Specialist for our customer at the United States Institute for Surgical Research (USAISR) in San Antonio Texas. In this role you wi…
Skills: Quality Assurance, Animal Study Monitoring, Audit Reporting, Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
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The role involves developing regulatory strategies and leading FDA interactions and submissions throughout the medical product lifecycle. The scientist will also provide risk assessments, maintain Target Product Profiles, and mentor junior personnel.
Candidates must have a Master's degree or higher in Life Sciences or a related field and hold a Regulatory Affairs Certification (RAC). A minimum of 12 years of FDA regulatory affairs experience with extensive submission expertise is required.
Description
Senior Regulatory Affairs Scientist
Venesco LLC is seeking a Senior Regulatory Affairs Scientist to serve as a senior regulatory subject matter expert responsible for developing regulatory strategies, leading FDA interactions, managing submissions, and ensuring compliance throughout the medical product lifecycle.
Requirements
Duties and Responsibilities
Minimum Qualifications
Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.
For more information on Venesco, LLC., visit https://venesco.com.
Venesco, LLC is a premier government contractor delivering Healthcare, IT, Research & Development, and a range of mission‑critical services to federal agencies. For more than 18 years, we’ve evolved from a small consulting firm into a respected leader in biomedical R&D and IT support, backed by strong financials, mature processes, and a commitment to employee connectedness and work–life balance. Our success is driven by our skilled professionals, agile management practices, and high‑quality standards. Venesco holds a Top‑Secret Facility Clearance and maintains CMMI® Maturity Level 3 (Services) and ISO 9001:2015 and 14001:2015 certifications. We’ve been recognized on the Inc. 5000 and Washington Technology’s Fast 50 lists for five consecutive years. With more than 350 credentialed employees and 65+ prime contracts — ranging from small teams to programs with 150+ personnel — we deliver the impact of a large enterprise while maintaining the agility of a small business. Venesco continues to recruit motivated, talented individuals who want to contribute to meaningful federal initiatives and join a collaborative, high‑performing team.
Offices: 400 Virginia Ave SW, Washington, District of Columbia 20024, US · 14801 Murdock Street Suite 125, Chantilly, Virginia 20151, US · 100 M St SE, Washington, District of Columbia 20003, US
Venesco, LLC is a premier government contractor delivering Healthcare, IT, Research & Development, and a range of mission‑critical services to federal agencies. For more than 18 years, we’ve evolved from a small consulting firm into a respected leader in biomedical R&D and IT support, backed by strong financials, mature processes, and a commitment to employee connectedness and work–life balance. Our success is driven by our skilled professionals, agile management practices, and high‑quality standards. Venesco holds a Top‑Secret Facility Clearance and maintains CMMI® Maturity Level 3 (Services) and ISO 9001:2015 and 14001:2015 certifications. We’ve been recognized on the Inc. 5000 and Washington Technology’s Fast 50 lists for five consecutive years. With more than 350 credentialed employees and 65+ prime contracts — ranging from small teams to programs with 150+ personnel — we deliver the impact of a large enterprise while maintaining the agility of a small business. Venesco continues to recruit motivated, talented individuals who want to contribute to meaningful federal initiatives and join a collaborative, high‑performing team.
Offices: 400 Virginia Ave SW, Washington, District of Columbia 20024, US · 14801 Murdock Street Suite 125, Chantilly, Virginia 20151, US · 100 M St SE, Washington, District of Columbia 20003, US
