SM-Director, Medical Writing

We're currently partnered with a leading biotech that are going through a very exciting growth period and are looking to add an accomplished Medical Writer to their team. They're a leading in their space and have a very strong pipeline.

Includes but not limited to:

• Leads the development and authoring of Investigational New Drug applications, clinical protocols, clinical study reports, investigator brochures, and clinical summaries in support of regulatory filings
• Leads the development and authoring of abstracts, posters, slides of clinical study data at medical congresses and the development of primary manuscripts for publication in peer-reviewed journals
• Provides medical writing support for briefing documents, information requests, nonclinical summaries, and additional documents intended for submission to HAs
• Facilitates document review committee meetings and issues resolution
• Provides project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents
• Organizes, conducts, and leads cross-functional document development meetings
• Closely interacts with statistics and programming departments in the development of statistical analysis plans and design of statistical outputs
• Routinely engages clinical research and biostatistics to gain comprehensive understanding of compound and the design, objectives, and results of clinical trials to enable accurate and effective communication to varied audiences

Requirements:

• Oncology is a must
• Experience in writing Regulatory documents: IND, NDA/BLA/MAA