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Medical Writer

Katalyst Healthcares & Life Sciences

Paramus, NJ

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JOB DETAILS
SKILLS
Best Practices, Biostatistics, Brochures, Clinical Data, Clinical Practices/Protocols, Clinical Study Publications, Clinical Support, Clinical Trial, Communication Skills, Computer Networks, Cross-Functional, Document Management, Drug Development, Editing, FDA (Food and Drug Administration), GCP (Good Clinical Practices), Healthcare Quality, ICH Regulations, Industry Standards, Industry/Trade Analysis, Maintain Compliance, Marketing, Medical Affairs, Medical Writing, Multitasking, New Drug Application, Pediatrics, Project/Program Management, Quality Assurance, Regulations, Regulatory Compliance, Regulatory Requirements, Research Protocols, Risk Management, Statistics, Technical Writing
LOCATION
Paramus, NJ
POSTED
30+ days ago
Responsibilities:
  • Develop clinical & regulatory documents (CSRs, CSPs, IBs, ICFs, CTD Modules, NDAs/BLAs/MAAs).
  • Ensure compliance with ICH, GCP, FDA & EMA guidelines.
  • Collaborate with Clinical, Regulatory, Biostatistics & Medical Affairs teams.
  • Manage multiple projects & timelines.
  • We are seeking a skilled Medical Writer to develop high-quality clinical and regulatory documents in compliance with industry standards and regulatory guidelines.
  • 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.
Regulatory Document Writing:
  • Prepare and author clinical and regulatory documents, including but not limited to.
  • Clinical Study Protocols (CSPs) and Protocol Amendments.
  • Clinical Study Reports (CSRs).
  • Investigator's Brochures (IBs).
  • Informed Consent Forms (ICFs).
  • Common Technical Document (CTD) Modules (e.g., Module 2.5 Clinical Overview, Module 2.7 Clinical Summary).
  • Briefing Documents for Regulatory Authorities (e.g., FDA, EMA) Periodic Safety Reports.
  • Risk Management Plans (RMPs) and Pediatric Investigation Plans (PIPs).
  • New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing.
  • Authorization Applications (MAAs) Responses to regulatory queries.
Clinical Development Support:
  • Develop and maintain clinical development plans, clinical trial protocols, and statistical analysis plans.
  • Collaborate with clinical teams to ensure alignment of clinical documents with study objectives and regulatory requirements.
  • Interpret complex scientific and clinical data and communicate findings clearly and concisely.
Regulatory Compliance & Standards:
  • Ensure documents comply with ICH, GCP, FDA, EMA, and other applicable regulatory agency guidelines.
  • Maintain up-to-date knowledge of regulatory writing best practices, industry trends, and evolving guidelines.
Collaboration & Review:
  • Work closely with cross-functional teams, including medical, clinical, regulatory, statistical, and quality assurance teams.
  • Review and edit documents prepared by internal teams or external vendors to ensure scientific accuracy, clarity, and compliance.
  • Participate in team meetings, regulatory interactions, and strategy discussions.
  • Drive document production timelines according to established plans.
  • Plan and manage multiple simultaneous document development projects with shifting priorities.

About the Company

K

Katalyst Healthcares & Life Sciences

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