Medical Writer, Consultant
Kaye/Bassman International
Location: Basking Ridge, New Jersey (Hybrid)
Duration: 3-Month Contract with Potential for Full-Time Conversion
Full-Time Contract Role: (40 hours/week)
Our client is seeking an experienced Medical Writer to support the preparation of clinical and regulatory documents across multiple development programs. This position offers the opportunity to work within a fast-paced, collaborative environment supporting clinical development and regulatory submission activities. The ideal candidate will possess strong scientific writing capabilities, a solid understanding of the drug development process, and experience developing regulatory-compliant clinical documentation.
Responsibilities:
- Author and support the development of Clinical Study Reports (CSRs), Protocols, Investigator's Brochures (IBs), DSURs, and regulatory submissions, including NDAs and BLAs
- Ensure documents comply with FDA, EMA, ICH-GCP, and applicable regulatory requirements
- Perform quality control reviews, including editorial review, formatting verification, cross-referencing, and source data verification
- Summarize efficacy and safety data into concise, scientifically accurate regulatory narratives
- Manage document formatting, tables, figures, references, appendices, and document consistency
- Incorporate reviewer feedback and facilitate comment resolution discussions
- Maintain timelines and proactively communicate project status to stakeholders
- Support document revisions, redlines, and change summaries as required
Qualifications:
- Advanced Degree in life sciences, scientific communications, or a related field
- 4+ years of pharmaceutical or biotechnology medical writing experience
- Experience in supporting regulatory submissions (BLA/NDAs)
- Experience authoring CSRs, Protocols, IBs, DSURs, and regulatory submission documents
- GCP or AMWA Certification
- Strong understanding of clinical development and regulatory submission processes
- Experience working with FDA, EMA, and ICH-GCP guidelines
- Excellent scientific writing, editing, and communication skills
- Strong attention to detail and ability to manage multiple priorities
- Proficiency with Microsoft Office and SharePoint
Vacancy posted 1 day ago
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