fda Jobs in maryland

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Senior Outcomes Specialist

E-Solutions, Inc.

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California, USA

Third Party

Job title: Senior Outcomes Specialist Location: Remote Mandatory Skills: SQL, SAS, R, or Python, Healthcare What's in it for you :- We are seeking a results-driven and analytical Senior Outcomes Specialist to support the Foundational Data Analytics (FDA) Program. This role will focus on measuring, analyzing, and improving clinical, operational, and financial outcomes across the enterprise. The ideal candidate will bring deep expertise in healthcare analytics, outcomes measurement, and perfor
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Posted 18 hours ago

Clinical Data Automation

Epis Data Inc

•

Remote

Contract

Title: c (SDTM/CDISC, AI/ML) Location: Remote Duration: Long Term Experience: 9+ Years Requirement: 1. Must already be familiar with SDTM/CDISC clinical data standards 2. MUST have a pharma environment/industry experience. 3. Previous experience implementing scalable AI solutions is ideal About the Role We are seeking a talented Python Developer with experience in clinical data standards (SDTM/CDISC) and a passion for AI/ML-driven automation. In this role, you will design and implement scalable
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Posted 22 hours ago

Principal Regulatory Consultant Dietary Supplements

Apptad Inc

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New Jersey, USA

Contract, Third Party

Job Description: Job Title: Principal Regulatory Consultant Dietary Supplements (U.S.-Based) Position Type: Contract / Consulting Location: Jersey City, NJ Department: Regulatory Affairs / Corporate Development Position Summary: We are seeking a highly experienced and credentialed Regulatory Consultant to support strategic M&A due diligence initiatives within the dietary supplement industry. This role demands deep understanding of the U.S. regulatory landscape, including DSHEA, FDA cGMPs (21 CFR
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Posted 14 days ago

Sr. Biostatistician needed for Remote Job longterm Contract!!!

Nam Info Inc

•

Remote or US

Third Party, Contract

Dear, Hope you are doing well. Send resumes along with expected bill rates on W2( NO Benefits) or Independent contractors only apply and share to Note : NO 3rd party candidates, or H1's/EAD's/OPT's please. Role : Sr. Biostatistician Location:Remote Duration : 6+ months contract EST time zone- candidate need to work in EST time Skills: At least 8years of experience In Addition to the above Statistical Programming II experience Lead statistica
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Posted 3 days ago | Updated 1 hour ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

•

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's
Posted 19 days ago | Updated 8 hours ago

CQV Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Job Description: We are seeking a highly motivated and experienced CQV Engineer to join PharmEng Technology, a leading global provider of engineering and consulting services to the pharmaceutical and biotechnology industries. The CQV Engineer will lead commissioning, qualification, and validation activities for new and existing pharmaceutical facilities and equipment. Responsibilities: Develop and execute commissioning, qualification, and validation protocols for new and existing pharmaceutical
Posted 8 days ago | Updated 8 hours ago

Remote QA Manager with Healthcare Payer and Claims exp

Infinite Computer Solutions (ICS)

•

Remote

Full-time

Note : GCEAD, L2EAD, consultant can apply for this position who can work on W2. Job Summary: We are looking for an experienced QA Healthcare Manager to lead the quality assurance team in ensuring the reliability, security, and compliance of healthcare applications. The ideal candidate should have a strong background in healthcare software testing, regulatory compliance (HIPAA, CMS, FDA), test automation, and team leadership. Key Responsibilities: we need someone who understand healthacre paye
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Posted 21 days ago | Updated 11 days ago

Senior Clinical SAS programmer with Pharma experience -Remonte-W2 -Contract

Biogensys

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Remote

Contract

Biogensys is currently hiring a Senior SAS programmer with Pharma experience for 6 to 12 months contract on w2. This is a remote position, no corp to corp, or 1099. No sponsorship is available. Statistical Programmer II: Pharma experience/Remote At least 7-8 years of experience in ADaM/TLF.Create, validate, and maintain SAS programs for data analysis, reporting, and submission deliverablesDevelop analysis datasets (ADaM) and tables, listings, and figures (TLFs) to support statistical analysis in
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Posted 6 days ago

Sr. Principal Statistics

PARAKEET WORLD SOLUTIONS LLC

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Remote

Contract

Job Title: Sr. Principal StatisticsLocation: Remote Duration: 6 MonthsEmployment Type: W2 ContractExperience Level: Mid-SeniorEducation Required: Ph.D. or MS in Statistics or BiostatisticsIndustry: Pharmaceuticals Job Summary:The Sr. Principal Statistician will lead statistical activities in clinical trials, from protocol development to final study reporting. The role will also contribute to regulatory filings, in-licensing evaluations, and marketing support. Key Responsibilities:Review protocol
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Posted 21 days ago

Statistical Programmer needed for Remote Job only EST candidates needed!!!

Nam Info Inc

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Remote or US

Full-time, Third Party, Contract

Dear, Hope you are doing well. Send resumes along with expected bill rates on W2( NO Benefits) or Independent contractors only apply and share to Note : NO 3rd party candidates, or H1's/EAD's/OPT's please. Role :Statistical Programmer II Location :Remote Duration : 6+ months contract EST ZONE CANDIDATES ONLY Statistical Programming II: Key responsibilities At least 5 years of experience in ADaM/TLF. Create, validate, and maintain SAS programs for data analysis, reporting, and submission de
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Posted 3 days ago | Updated 1 hour ago

Clinical Data manager

Intone Networks Inc.

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Remote

Contract, Third Party

Need stronger with working on Data Acquisition, DTAs and vendor relations. Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.Assist in creating external data transfer agreements, ensuring alignment with Takeda Standards and specifications to support data integration, analysis, and reporting.Provide support in setting up infrastructure for external data to flow into T
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Posted 10 days ago | Updated 5 days ago

DTS Lead - Intelligent Clinical Supply Management

Quantum Integrators Group LLC

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Remote or King of Prussia, Pennsylvania, USA

Contract, Third Party

Role Name: DTS Lead - Intelligent Clinical Supply Management (ICSM) Location: King of Prussia, PA. REMOTE 6+ Months contract Job Description The DTS Lead ICSM is responsible for leading the design, implementation, and optimization of SAP's Intelligent Clinical Supply Management (ICSM) solution. This role supports clinical trial operations by ensuring efficient planning, forecasting, packaging, labeling, and distribution of clinical trial materials across global sites, while maintaining regulato
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Posted 5 days ago | Updated 1 day ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 8 hours ago

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 9 days ago | Updated 8 hours ago

Manufacturing Technical Writer--EAM

Eliassen Group

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Anywhere, US

Contract

Description: **Hybrid onsite | 3x a week | Mesa, AZ** Our client has an exciting opportunity for a Manufacturing Technical Writer--EAM. Due to client requirement, applicants must be willing and able to work on a w2 basis. For our w2 consultants, we offer a great benefits package that includes Medical, Dental, and Vision benefits, 401k with company matching, and life insurance. Rate: $25 - $35 / hr. w2 Responsibilities: Rewrite Process Instructions for new Asset Management system, working w
Posted 20 hours ago | Updated 8 hours ago

IT Enterprise Architect with Life Science Experience

K Source Inc

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Remote

Contract, Third Party

Hi , This is Sagar from KSource Inc. We have an excellent job opportunity for you below is the JD please have a look. Job Title: IT Enterprise Architect with Life Science Experience Location: Boston, MA (Remote) Duration: 12+ months Job Description: The IT Enterprise Architect is a key role within Gates MRI IT, combing a blend of deep technical and architectural expertise with industry foresight, and strategic thinking. This position is essential for crafting a cohesive IT architecture that sup
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Posted 4 days ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 28 days ago | Updated 8 hours ago

Data Manager MedRA Coder (WHODrug)

General Dynamics

•

Frederick, Maryland, USA

Full-time

Type of Requisition: Pipeline Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: NACI (T1) Job Family: Medical Affairs Job Qualifications: Skills: Clinical Data Management, Electronic Data Capture (EDC), MedDRA Coding, WHODrug Certifications: None Experience: 5 + years of related experience ship Required: Yes Job Description: GDIT's Military Health team is hiring Data Manager MedRA Coder (WHODrug) to support the Office of
Posted 18 days ago | Updated 8 hours ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 29 days ago | Updated 8 hours ago

Senior Appian Developer

General Dynamics

•

Gaithersburg, Maryland, USA

Full-time

Type of Requisition: Pipeline Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: Other Job Family: Software Engineering Job Qualifications: Skills: Appian (Platform), Appian BPM, Appian Process Automation Certifications: None Experience: 5 + years of related experience ship Required: No Job Description: General Dynamics Information Technology is seeking numerous candidatesto fill multiple-level Appian Developer roles on
Posted 50 days ago | Updated 8 hours ago