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.
...Seeking a full-time remote Jira Administrator, the ideal candidate will manage the transition to an outcome-based planning system within Jira, lead a Planning Center of Excellence, and design strategic models for product outcomes and reporting.Key ResponsibilitiesLead...
...Job Description Job Description Job Description Apply now at ABOUT THE JOB Do you know why Domino's Pizza hires so many drivers? Well, aside from the fact that our delicious pizza is the perfect solution for dinner for families all across the nation -...
...invite you to join our Wireless Team. Customer Experience Representative We are seeking... ...for providing exceptional customer service while ensuring that they have a positive... ...Company We are a locally owned and operated Verizon Authorized Retailer. Our first location...
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...Job Description Job Description *This is PDR, AS NEEDED position. Job Summary The Dietary Services Cook/Aide is responsible for helping prepare and serve nutritious meals to patients, staff, and visitors in accordance with prescribed dietary requirements and...