Familiar with FDA's Project Optimus guidance. * Well-informed in current and emerging standards of regulatory requirements and expectations for clinical pharmacology. * Hands-on experience with ...
Familiar with FDA's Project Optimus guidance. * Well-informed in current and emerging standards of regulatory requirements and expectations for clinical pharmacology. * Hands-on experience with ...
LIMS SME/Business Analyst
Atlanta, GA · Remote
Work with end users and management to analyze and document user needs Participate in and facilitate meetings, Work with the project team and FDA leadership to identify data needs for LIMS and/or ELN ...
LIMS SME/Business Analyst
Atlanta, GA · Remote
Work with end users and management to analyze and document user needs Participate in and facilitate meetings, Work with the project team and FDA leadership to identify data needs for LIMS and/or ELN ...
FDA Technical Consultant
Washington, DC · On-site
Perform special projects as assigned SKILLS NEEDED TO BE SUCCESSFUL * Regular travel within the ... FDA experience required. * Minimum of 5 years as an FDA investigator or compliance officer, or ...
FDA Technical Consultant
Washington, DC · On-site
Perform special projects as assigned SKILLS NEEDED TO BE SUCCESSFUL * Regular travel within the ... FDA experience required. * Minimum of 5 years as an FDA investigator or compliance officer, or ...
FDA Technical Consultant
Washington, DC · On-site +1
Perform special projects as assigned SKILLS NEEDED TO BE SUCCESSFUL * Regular travel within the ... FDA experience required. * Minimum of 5 years as an FDA investigator or compliance officer, or ...
FDA Technical Consultant
Washington, DC · On-site +1
Perform special projects as assigned SKILLS NEEDED TO BE SUCCESSFUL * Regular travel within the ... FDA experience required. * Minimum of 5 years as an FDA investigator or compliance officer, or ...
... skills FDA Project Information : LabAnswer is pursuing a contract with the Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA) for the continued implementation, deployment ...
... skills FDA Project Information : LabAnswer is pursuing a contract with the Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA) for the continued implementation, deployment ...
... project management support. Brillient will deliver solutions and technical/scientific resources to meet the needs of program offices and centers across all of FDA.
... project management support. Brillient will deliver solutions and technical/scientific resources to meet the needs of program offices and centers across all of FDA.
FDA Food Contract and Training Specialist
Lansing, MI · On-site
$34.12 - $50.12/hr
The FDA Food Contract specialist is responsible for managing and overseeing timely, successful ... project confidence; the ability to utilize and implement sound decision-making skills; a ...
FDA Food Contract and Training Specialist
Lansing, MI · On-site
$34.12 - $50.12/hr
The FDA Food Contract specialist is responsible for managing and overseeing timely, successful ... project confidence; the ability to utilize and implement sound decision-making skills; a ...
Project Manager
Silver Spring, MD · On-site
$85K/yr
E-logic is seeking a veteran Project Manager (PM) to lead a mission-critical federal contract supporting the Food and Drug Administration (FDA). In this role, you will serve as Key Personnel ...
Quick apply
Project Manager
Silver Spring, MD · On-site
$85K/yr
E-logic is seeking a veteran Project Manager (PM) to lead a mission-critical federal contract supporting the Food and Drug Administration (FDA). In this role, you will serve as Key Personnel ...
... and project management support. Brillient will deliver solutions and technical/scientific resources to meet the needs of program offices and centers across all of FDA. Experience and Skills Please ...
... and project management support. Brillient will deliver solutions and technical/scientific resources to meet the needs of program offices and centers across all of FDA. Experience and Skills Please ...
Laboratory Compliance Officer
Denver, CO · On-site +1
$69.02K - $75.93K/yr
Dairy Laboratory Oversight Under FDA/PMO As a certified Laboratory Evaluation Officer (LEO}, use knowledge of applicable FDA Grade A Pasteurized Milk Ordinance federal regulation to evaluate dairy ...
Laboratory Compliance Officer
Denver, CO · On-site +1
$69.02K - $75.93K/yr
Dairy Laboratory Oversight Under FDA/PMO As a certified Laboratory Evaluation Officer (LEO}, use knowledge of applicable FDA Grade A Pasteurized Milk Ordinance federal regulation to evaluate dairy ...
$155.80K - $205.60K/yr
Must exercise judgment within defined procedures and policies to determine appropriate regulatory direction and communicate toServes as primary point of contact with FDA project manager for assigned ...
$155.80K - $205.60K/yr
Must exercise judgment within defined procedures and policies to determine appropriate regulatory direction and communicate toServes as primary point of contact with FDA project manager for assigned ...
Manage and track client projects, project deliverables, invoices, and budgets * Participate in developing business and marketing to clients You will have the following skills and qualifications
Manage and track client projects, project deliverables, invoices, and budgets * Participate in developing business and marketing to clients You will have the following skills and qualifications
Laboratory Compliance Officer
Denver, CO · On-site +1
$69.02K - $75.93K/yr
Dairy Laboratory Oversight Under FDA/PMO As a certified Laboratory Evaluation Officer (LEO}, use knowledge of applicable FDA Grade A Pasteurized Milk Ordinance federal regulation to evaluate dairy ...
Laboratory Compliance Officer
Denver, CO · On-site +1
$69.02K - $75.93K/yr
Dairy Laboratory Oversight Under FDA/PMO As a certified Laboratory Evaluation Officer (LEO}, use knowledge of applicable FDA Grade A Pasteurized Milk Ordinance federal regulation to evaluate dairy ...
... FDA-regulated initiatives ... Provide technical and management leadership across major project tasks, driving innovation and ...
Quick apply
... FDA-regulated initiatives ... Provide technical and management leadership across major project tasks, driving innovation and ...
Experience in food and beverage manufacturing (dairy preferred) with working knowledge of FDA/PMO requirements or the ability to quickly learn and apply them in a fast-paced environment. working ...
Experience in food and beverage manufacturing (dairy preferred) with working knowledge of FDA/PMO requirements or the ability to quickly learn and apply them in a fast-paced environment. working ...
... FDA-regulated initiatives ... Provide technical and management leadership across major project tasks, driving innovation and ...
... FDA-regulated initiatives ... Provide technical and management leadership across major project tasks, driving innovation and ...
FDA Validation Engineer
Nashville, TN · On-site
Write overall project quality (validation scope) plans and validation summary reports. * Organize, guide, and write requirement specifications. * Oversee, execute and review qualification ...
FDA Validation Engineer
Nashville, TN · On-site
Write overall project quality (validation scope) plans and validation summary reports. * Organize, guide, and write requirement specifications. * Oversee, execute and review qualification ...
Project Engineer
Richmond, VA · On-site
Project Engineer Location: Richmond, VA. Duration: Longterm Job Summary: Project Engineer role ... The role requires strong experience in pharma or FDA-regulated environments with GMP knowledge and ...
Quick apply
Project Engineer
Richmond, VA · On-site
Project Engineer Location: Richmond, VA. Duration: Longterm Job Summary: Project Engineer role ... The role requires strong experience in pharma or FDA-regulated environments with GMP knowledge and ...
... FDA-regulated initiatives ... Provide technical and management leadership across major project tasks, driving innovation and ...
... FDA-regulated initiatives ... Provide technical and management leadership across major project tasks, driving innovation and ...
Director, Clinical Pharmacology
Redwood City, CA · On-site
$211K - $264K/yr
Familiar with FDA's Project Optimus guidance. * Well-informed in current and emerging standards of regulatory requirements and expectations for clinical pharmacology. * Hands-on experience with ...
Director, Clinical Pharmacology
Redwood City, CA · On-site
$211K - $264K/yr
Familiar with FDA's Project Optimus guidance. * Well-informed in current and emerging standards of regulatory requirements and expectations for clinical pharmacology. * Hands-on experience with ...
Fda Project information
What are the key skills and qualifications needed to thrive as an FDA Project Manager, and why are they important?
To thrive as an FDA Project Manager, you need a strong background in regulatory affairs, project management, and a degree in life sciences or a related field. Familiarity with FDA submission requirements, electronic common technical document (eCTD) systems, and project management tools like MS Project or Asana is essential. Excellent communication, organization, and problem-solving abilities help manage cross-functional teams and ensure compliance. These skills ensure that projects meet regulatory standards, progress efficiently, and achieve timely FDA approvals.
What are some common challenges faced by professionals working on FDA project teams?
Professionals working on FDA project teams often encounter challenges related to regulatory compliance and shifting guidelines. Navigating complex documentation requirements, coordinating with cross-functional teams (such as clinical, regulatory, and quality assurance), and meeting strict submission deadlines are all common hurdles. Effective communication and adaptability are essential, as projects frequently involve collaboration across departments and ongoing updates based on regulatory feedback. Successfully managing these challenges helps ensure product approval and supports career advancement within regulatory affairs.
What is an FDA Project?
An FDA Project typically refers to a project that involves compliance with the U.S. Food and Drug Administration (FDA) regulations. These projects can include developing, testing, or bringing to market medical products such as drugs, medical devices, biologics, or food items. The goal of an FDA Project is to ensure that products meet safety, efficacy, and quality standards set by the FDA before they are approved for public use. Such projects often require extensive documentation, clinical trials, and regulatory submissions to obtain FDA approval.
What is the difference between Fda Project vs Fda Reviewer?
| Aspect | Fda Project | Fda Reviewer |
|---|---|---|
| Required Credentials | Typically requires a background in life sciences, engineering, or related fields; often includes project management certifications | Requires a degree in life sciences, pharmacy, or medicine; often needs FDA-specific training or experience |
| Work Environment | Project teams within pharmaceutical or biotech companies, regulatory agencies, or consulting firms | Regulatory agencies, pharmaceutical companies, or biotech firms reviewing submissions |
| Employer & Industry Usage | Used in project management contexts to oversee regulatory submissions and compliance | Used in regulatory review processes to evaluate drug, device, or food applications |
In summary, Fda Project roles focus on managing regulatory initiatives and ensuring compliance within organizations, while Fda Reviewers are responsible for evaluating and approving submissions directly for regulatory approval.
More about Fda Project jobs
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Job description
The Opportunity:
We are seeking a passionate and experienced Clinical Pharmacologist with strong early development background to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization.
As a member of the Early Development Clinical Pharmacology group, you will:
Provide strategic insight and technical leadership within the Clinical Pharmacology function.
Author technical reports and/or regulatory documents for major milestones of clinical development, specifically IND, EOP1 & EOP2 Briefing Documents. Participate in regulatory interactions and responses to regulatory questions.
Apply state-of-the-art quantitative modeling, including translational PK/PD, population PK, and exposure-response analyses, to guide recommended phase 2 dose/schedule (RP2Ds) selection for pivotal studies.
Work with the Discovery organization to support assets in the IND-enabling stage, including collaboration with DMPK and Toxicology groups in assessment of human start dose and assessment of the need for human DDI studies.
Work with the Clinical Development team in designing FIH study.
Design and report Clin Pharm studies such as hADME, Food-Effect and DDI studies.
Engage and work with CROs on clinical pharmacology activities.
Represent the Clinical Pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions.
Required Skills, Experience and Education:
A Ph.D. or Pharm.D (with Fellowship) with Pharmaceutical Sciences background with 8+ years of relevant industry experience in Clinical Pharmacology.
Prior experience with small molecules oncology drug development.
Familiar with FDA's Project Optimus guidance.
Well-informed in current and emerging standards of regulatory requirements and expectations for clinical pharmacology.
Hands-on experience with WinNonlin and Clin Pharm study designs.
Strong understanding of DMPK, CMC and Toxicology and related regulatory guidance is required.
Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences.
A critical thinker and passionate team player and quick learner with high energy who thrives in a dynamic and fast-paced environment.
Prior management experience.
Preferred Skills:
Prior experience interacting with FDA on dose optimization.
Hand-on experience with PBPK models.
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