Medical Writer
Katalyst HealthCares & Life Sciences, Paramus, NJ, United States
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.
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.