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Lori Steiner's Jobs at NeedLS
Principal and Owner | NeedLS

About Company
Science & Biotech - Durham, NC 27703

The Senior Medical Writer will be responsible for reviewing, authoring and revising clinical and regulatory documents for submission to the FDA and other agencies, and to support other clinical communication efforts including abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals. Prepares Investigational New Drug (IND) applications, amendments, annual reports, New Drug Applications (NDA) and/or Marketing Authorization Applications (MAA), and other documents to support global product deve...

View ***REMOTE*** Sr. Medical Writer Job - Durham, NC 27703
Science & Biotech - Paramus, NJ 07652

This position will be focused on ensuring GCP Compliance with global regulations, driving and implementing the Company’s Compliance Directives and supporting the Quality Management System to ensure Compliance and minimize risk in a regulated Pharmaceutical environment. The incumbent will plan, conduct, lead and/or participate in all GCP-QA (CRO, Sites, DM/STATs and PVG including systems) audit programs, including both internal and external GCP Audits. This position will also provide day-to-day support to the Head of Quality Assurance in Clinical Oper...

View QA Auditor (GCP), Associate Director Job - Paramus, NJ 07652
Science & Biotech - Richmond, VA 23173

this individual will have responsibility for providing CMC regulatory leadership and strategy required to achieve regulatory approvals, collaborating closely with multiple scientific, technical, quality, and commercial areas within the company and with external contract manufacturing organizations (CMOs). This position provides knowledge, understanding, interpretation, and utilization of regulatory guidances and regulations, as well as industry and government agency best practices and trends. Responsibilities: Lead, develop, and implement CMC r...

View Sr. Director CMC Regulatory Job - Richmond, VA 23173
Science & Biotech - Durham, NC 27710

The Manager Drug Regulatory Affairs is responsible for planning, managing and tracking regulatory documentation, and successful preparation and filing of submissions (DMF, ANDA, NDA) in the required electronic format. This role serves as the system owner for regulatory information tools and technologies, and develops processes to ensure submission are complete and comply with applicable regulatory requirements, in a fast-paced environment. This individual collaborates with cross-functional teams (RA, QA, IT, etc.) to bring excellence in regulatory p...

View CMC Regulatory Manager Job - Durham, NC 27710
Science & Biotech - Cambridge, MA 02138

A highly visible position repsponsible for creating and executing program stategy for research organization to lead programs to IND and clinical development. Responsibilities: • Responsible for creation, management, and communication of Integrated Development Plan • Lead cross-functional communication, drive strategic and operational alignment with the program team, functional leads, and Executive Leadership Team • Work with a cross functional team to prepare study designs, manage budgets and oversee the study from initiation to report generation...

View Sr. Director, Program Management Job - Cambridge, MA 02138