In this role, incumbent will be expected to provide Medical Writing leadership for clinical development, registrational, and LCM programs. Serves as lead Medical Writer for key programs. Coordinates medical writing support for programs with internal and contract writers. Additionally, must possess the ability to guide and assist medical writers in the writing of documents that are components of clinical/regulatory approval applications for new biologics or NME applications. Documents include: Sections of clinical trial applications, Annual Reports, and BLA/NDAs, Protocols and Protocol Amendments, Model Informed Consents, Model Privacy Consents, Investigator Brochures, Clinical Study Reports, and Expert Reports and other documents as appropriate. Additional skills: must be a strong technical leader, manage with excellent scientific, strategic and customer focused leadership. Partner with Clinical Operations and R&D team members to ensure completion of high quality, timely, clinical documentation. Expected Qualification: Masters or PhD in biology or related discipline. Equivalent combination of education and experience considered. 7+ years of related experience in biotech or pharmaceutical environment. Must have strong scientific and operational background. At least 3 years of experience managing staff.
...Creative Arts Therapist Katonah, NY, US Salary: $30,400 annually for 20 hours/week Four Winds Hospital, a leading provider of psychiatric inpatient services that treats children, adolescents, and adults, seeks part-time (20 hours/week) creative arts therapist...
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...Title: Data Modeler Commercial Life Sciences POSITION OVERVIEW We are seeking a Data Modeler to join our team in supporting a Databricks unified data platform initiative. The primary focus is building a common data model and developing reusable, high-impact data...