Medical Writer Job at Katalyst Healthcares and Life Sciences in Paramus
Katalyst Healthcares and 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.
- 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.
- uthorization Applications (MAAs) Responses to regulatory queries.
- 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.
- 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.
- 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.