Top 825440 Documentation Jobs

FDA Submissions Specialist
Confidential Healthcare Company —Los Angeles, CA
- $30 - $45 an hour
- Full-time
- Hybrid work
- 5 years
- Writing skills
- Doctor of Philosophy
- Health insurance
- Dental insurance
Quick Apply
Data Compliance Administrator
PROtect, LLC —Artesia, NM
- $30 an hour
- Extended hours
- 5 years
- Analysis skills
- Quality control
- Health savings account
- Dental insurance
Quick Apply
11d
Documentation Control Manager
C.E. NIEHOFF & Co. —Chicago, IL
- $30 - $60 an hour
- Full-time
- Microsoft Outlook
- CAD
- Word processing
- Paid holidays
- Disability insurance
Quick Apply
GMP LIMS Technical Documentation Specialist
Lenox Executive Search —Swiftwater, PA
- $45 - $50 an hour
- Contract
- Microsoft Word
- Background check
- Microsoft Outlook
Quick Apply
7d
Senior Clinical Data Manager
Vforce Infotech —Edison, NJ
- $110,000 - $120,000 a year
- Full-time
- Analysis skills
- Bachelor's degree
- Continuous improvement
Quick Apply
Data Analyst II - Remote Position
Trinity Health —Livonia, MI
- $86,175 - $129,263 a year
- Full-time
- Remote
- Computer Science
- Mid-level
- Project management
Requirements/Documentation Analyst
Guidehouse Digital, LLC —Washington, DC
- $98,000 - $163,000 a year
- Full-time
- Remote
- Mid-level
- Bachelor's degree
- Fair chance
- Commuter assistance
- Health savings account
Technical Data Reviewer
RMS Energy —Remote
- Remote
- Background check
- Computer Science
- OSHA
- Paid training
- Paid holidays
Quick Apply
Documentation Manager
Clinical Ink —Remote
- 5 years
- Bachelor's degree
- Organizational skills
Quick Apply
Data Quality Analyst
ATC —Indianapolis, IN
- Contract
- Continuous improvement
- Senior level
Document Control Administator
Integer Holdings Corporation —Plymouth, MN
- $24.59 - $36.07 an hour
- Full-time
- Microsoft Word
- Microsoft Excel
- Computer literacy
- Disability insurance
- Health insurance
Quick Apply
Epic Application Analyst II - Radiant
Boston Medical Center —Remote
- $71,500 - $104,000 a year
- Full-time
- Remote
- Background check
- Research
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Epic PB Analyst
HCTec —Remote
- From $100,000 a year
- Full-time
- Remote
- Mid-level
- US work authorization
- Epic
- Health insurance
- Dental insurance
Quick Apply
10d
QMS Documentation & Training Analyst
bioventus —Memphis, TN
- Full-time
- Mid-level
- Continuous improvement
- Organizational skills
Documentation Control Specialist
RAMPART IC LLC —Vestavia Hills, AL
- ERP systems
- Mid-level
- 3 years
Data Governance Analyst
Indeed —Remote
- $70,000 - $146,000 a year
- Full-time
- Computer science
- Mid-level
- Military encouraged
- Health insurance
- Paid time off
Quick Apply
3d
Healthcare Data Quality Analyst
ATC —Indianapolis, IN
- Contract
- Senior level
QC Contractor
Katalyst Healthcares & Life Sciences —Avenel, NJ
- Contract
- Hybrid work
- Mid-level
- 3 years
- SharePoint
Quick Apply
Data Entry Operator - SAP BRIM
BVA Bear's IT Solutions —Boiling Springs, PA
- Full-time
- Hybrid work
- Mid-level
- High school diploma or GED
- Associate's degree
- Health insurance
- Work from home
Quick Apply
Ambulatory Clinical Documentation Integrity Specialist (Remote)
Trinity Health —Livonia, MI
- $75,592.71 - $113,389.06 a year
- Full-time
- Remote
- Nursing
- Mid-level
- Analysis skills

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FDA Submissions Specialist

Confidential Healthcare Company
Los Angeles, CA

Quick Apply

Job Details

Full-time
$30 - $45 an hour

Benefits

Health insurance
Dental insurance
Paid time off
Vision insurance

Qualifications

Writing skills
FDA 21 CFR Part 11
GMP
Laboratory regulatory affairs
Attention to detail
Master of Science
ICH Q10
Chemistry, manufacturing & controls
Biomedical regulatory compliance
Clinical quality assurance standards
Internal audits

Full Job Description

The Opportunity

We are seeking a seasoned FDA Submissions Specialist who brings deep, hands-on expertise in navigating the full spectrum of FDA submission processes. This is not an advisory role — we need someone who has personally led and authored regulatory submissions, understands the intricacies of Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP), and can serve as a strategic regulatory partner across the organization. You will take direct ownership of our submission pipeline, drive regulatory strategy from early development through approval, and be the internal authority on FDA requirements, pathways, and evolving guidance.

Non-Negotiable Requirement

Candidates must have direct, hands-on experience preparing and submitting at least one of the following to the FDA: 510(k), IND, BLA, NDA or PMA. Advisory or supporting roles do not meet this requirement — we are looking for individuals who served as core contributors to the submission itself.

What You’ll Do

Lead the end-to-end preparation, assembly, and submission of FDA applications — including 510(k)s, INDs, BLAs, and PMAs — from initial planning through agency receipt, ensuring completeness, accuracy, and strategic framing at every step.
Manage the full lifecycle of active submissions, including amendments, supplements, annual reports, and responses to FDA information requests or deficiency letters.
Author and review responses to FDA information requests, deficiency letters, Complete Response Letters (CRLs), and Refuse-to-File (RTF) notifications with clarity and technical precision.
Serve as the primary point of contact for FDA interactions — preparing meeting requests, briefing documents, and written responses, and representing the company during agency communications.
Develop and own regulatory strategy for pipeline programs, assessing submission pathways, identifying risks early, and advising leadership on optimal routes to approval.
Advise leadership and cross-functional stakeholders on regulatory requirements, timelines, and strategic options to support program decisions.
Ensure ongoing inspection readiness by maintaining robust regulatory compliance across all processes, documentation, and activities per 21 CFR Parts 11, 50, 54, 56, 58, 210/211, 312, 314, 600-series, 820, and applicable ICH guidelines (E6, Q8-Q10).
Support internal audits, CAPA development, and gap assessments aligned with GLP, GMP, and GCP standards.
Collaborate cross-functionally with Clinical Operations, Medical Affairs, R&D, and Quality to align regulatory requirements with program timelines and deliverables.
Provide regulatory support for Chemistry, Manufacturing, and Controls (CMC) sections of INDs, BLAs, NDAs, and supplements, including review of drug substance and drug product specifications, stability data, and manufacturing process descriptions.
Support regulatory strategy for CMC development milestones, including IND- enabling studies, Phase 2/3 manufacturing scale-up, and BLA/NDA readiness assessments aligned with ICH Q8, Q9, Q10, and Q11 guidelines.
Provide regulatory training and guidance to internal teams on submission requirements, compliance obligations, and agency expectations.

What You’ll Bring

Education & Experience

Bachelor’s degree in a scientific or engineering discipline; advanced degree (M.S., Ph.D., Pharm.D., RAC) strongly preferred.
5+ years of FDA regulatory affairs experience in biotech, pharma, or medical devices, with verifiable, hands-on submission authorship.
Direct experience with one or more submission types: 510(k), IND, BLA, or PMA — from drafting through submission and agency follow-up.
Experience with both drug/biologic and device regulatory pathways is a strong differentiator.

Skills and Attributes

Deep command of 21 CFR Parts 50, 54, 56, 58, 210/211, 312, 314, 600-series, and 820, as well as ICH guidelines (E6 GCP, Q8-Q10 pharmaceutical development, and M4 CTD format).
Familiarity with eCTD structure and electronic submission requirements via the FDA Electronic Submissions Gateway (ESG).
Understanding of nonclinical study designs (GLP toxicology, pharmacology) andtheir regulatory significance for IND/NDA/BLA filings.
Ability to clearly communicate complex regulatory requirements to both technical and non-technical stakeholders, including senior leadership.
Highly organized and detail-oriented, with the ability to manage multiple submissions and priorities simultaneously in a fast-paced environment.

Benefits:

Competitive salary: $27-45 an hour
Comprehensive health benefits package including medical, dental, and vision insurance.

Job Type: Full-time

Pay: $30.00 - $45.00 per hour

Benefits:

Dental insurance
Health insurance
Paid time off
Vision insurance

Work Location: Hybrid remote in Los Angeles, CA 90066

Quick Apply

Refine Your Search

documentation jobs

FDA Submissions Specialist

Data Compliance Administrator

Documentation Control Manager

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Requirements/Documentation Analyst

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Ambulatory Clinical Documentation Integrity Specialist (Remote)

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