14 Results for

Author Jobs in Madison, NJ

Jobs

New Brunswick, NJ10 days ago

$42.85–$45.45 Per Hour

Responsibilities:Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports. Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy.

New York, NY17 days ago

$48.57–$50 Per Hour

The AEM Author is responsible for creating, editing, managing, and publishing digital content using Adobe Experience Manager (AEM). Skills: Category Name Required Importance Experience SkillCategoryTest1_MN Digital : Adobe Experience Manager (AEM) Yes 1 >7 years

New Brunswick, NJ25 days ago

o Primary Responsibilities: o Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports. o Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy.

Paramus, NJ30+ days ago

The ideal candidate will collaborate with cross-functional teams, including Clinical, Regulatory, Biostatistics, and Medical Affairs, to create well-structured, scientifically accurate, and regulatory-compliant documents. Collaboration & Review: Work closely with cross-functional teams, including medical, clinical, regulatory, statistical, and quality assurance teams.

Paramus, NJ12 days ago

$45–$49 Per Hour

This role bridges drug development, manufacturing, and quality control to deliver high-quality eCTD submissions. Compliance & Risk Management: Identify/escalate CMC regulatory risks and propose mitigation strategies.

New Brunswick, NJ25 days ago

$40–$42 Per Hour

Primary Responsibilities:Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports. Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy.

New Brunswick, NJ25 days ago

$33.03–$41.95 Per Hour

New!

New York, NY4 days ago

$50–$56 Per Hour

Key Requirements and Technology Experience:Key skills: Regulatory submission, Technical Writer/Regulatory Writing, AuthoringCMC Regulatory AuthoringRegulatory submissionsBS/BA, MS, or PhD , from an accredited school in a science/health field (e.g., Biology, Analytical Chemistry, Pharmacy, or a related field).Candidates must possess Chemistry, Manufacturing and Controls (CMC) and CTD authoring experience (Modules 2 and 3).A background in pharmaceutical manufacturing or quality control/quality assurance is a plus. Responsibilities:The technical writer develops and authors chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post‑approval regulatory dossiers within pre‑established timelines.

NY30+ days ago

$90,000–$130,000 Per Year

Preferred: Experience with large healthcare datasets (EHR, claims, monitoring data) Knowledge of IRB processes and regulatory requirements Experience with digital health, virtual care, or outcomes research Prior authorship in CV journals or presentations at major cardiology conferences (ACC, AHA, HRS, ESC). Required: Advanced degree (MD, PhD, MPH, MS, or equivalent) Experience conducting clinical research or real-world evidence studies Strong statistical and data analysis skills Demonstrated experience writing and publishing peer-reviewed manuscripts Familiarity with cardiovascular clinical research preferred.

New Brunswick, NJ25 days ago

$68,702–$87,256

This includes supporting Module 2.3 and Module 3 content, coordinating source documentation, managing submission timelines, reviewing and adjudicating comments, facilitating data verification, and helping ensure consistency and clarity across the dossier. This position requires close collaboration with Process Development, Analytical Development, Cell Therapy Technical Operations, Quality, Regulatory Sciences, CMC matrix team leaders, project management, document management, and external suppliers as needed.

Springfield, NJ30+ days ago

This role will work closely with internal and client cross-functional teams, including quality assurance, regulatory, production, and project management, to ensure timely delivery, accuracy, and clarity of all technical documents essential for the manufacturing and regulatory processes in a pharmaceutical industry. Document Management: Assist in the management of controlled documents in document control systems (e.g., electronic document management systems), ensuring traceability, version control, and appropriate distribution of approved documents.

Union, NJ30+ days ago

$45–$50

Experience authoring a variety of document types, including system design documents, project management-related plans, user guides/manuals, and training materials . Advanced skills using Microsoft Word (including creating, editing, deleting styles; track changes; and maintaining proper version control), Excel, and PowerPoint .

NY30+ days ago

Remote

$95,000–$105,000 Per Year

In addition to representing the Clinical Communications team as a content expert, the Principal Medical Writer interfaces with clients, promotional review teams, key opinion leaders, and a variety of internal professional services. • Assist writers/editors on the team in workload prioritization with deliverables and timelines of projects, prioritizing timely delivery of high-quality content.

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Author Jobs in Madison, NJ

Quality - Technical writer ECLARO

AEM Author Varite, Inc

Quality - Technical writer Mindlance

Medical Writer Katalyst Healthcares & Life Sciences

Pharmaceutical CMC Writer Macpower Digital Assets Edge Private Limited

Technical writer Sunrise Systems Inc

Technical writer Integrated Resources, Inc

Technical Writer II Pyramid Consulting

Clinical Research Writer Heartbeat Health Inc

Regulatory CMC Technical Writer SOKOL GxP Services

Technical Writer CEDENT

On Site Technical Writer - Union, NJ Adaptation

Principal Medical Writer MJH Healthcare Holdings LLC

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