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.
Elior is seeking a Part-Time Registered Dietitian to support high-quality dining experiences across our healthcare, senior living, and hospitality accounts. In this role, you will assess nutritional needs, develop individualized care plans, and provide counseling that supports...
...and university dining and catering operations. Since we are constantly growing, we have a wide range of clients with various waiter/waitress needs (conference services, banquets, and a la carte) which allows us to offer a wide array of temporary and long-term...
...Serve Up Something Meaningful Join Us as a Food Service Worker! Looking for a steady, full-time job where you can make a difference every day? As a Food Service Worker, youll help prepare and serve meals to students and staff in a safe, clean, and friendly environment...
...Job Description Insight Global is seeking a Lapping Technician to assist with the manufacturing and testing of energetics and artillery weaponry at the artillery test range. Skills and Requirements United States Military Experience. Specifically, Combat Engineering...
...The Lead Data Engineer is responsible for architecting, building, and operationalizing data pipelines that support enterprise data and analytics initiatives.This role leads the development and optimization of data pipelines, ensures high data quality, mentors team members...