- Parexel (Atlanta, GA)
- …FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate , you will serve as the ... and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of… more
- GRAIL (Atlanta, GA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- Sumitomo Pharma (Atlanta, GA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …contribute to the excellence of our academic community. **Description** Reporting directly to the Senior Associate Dean for Faculty Affairs , the Associate ... senior leader within the School of Medicine, the Associate Dean holds responsibility for key aspects of administrative... Dean and to the University Research Compliance and Regulatory Affairs Department on research misconduct and… more
- Boehringer Ingelheim (Athens, GA)
- …Associate Director, RA Service Center will hold full accountability for the Regulatory Affairs (RA) US outsourcing program, ensuring its successful execution ... of the RA US outsourcing program, executed in collaboration with External Regulatory Affairs Services (ERAS). The program supports international Boehringer… more
- Veterans Affairs, Veterans Health Administration (Augusta, GA)
- …coding practices, guidelines, conventions, and policies with instruction from a senior coder or supervisor. Reviews record documentation to abstract required ... under guidance. Refers coding and documentation questions from providers to a senior coder or supervisor for resolution or guidance. Utilizes the facility's computer… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... The Associate Director of Regulatory Intelligence leads...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- United Therapeutics (Atlanta, GA)
- …communication with teammates and appreciate the opportunity to collaborate with senior management, CPLs, MSL Field Directors, MSLs, Medical Communications and ... (slides, FAQ, talking points etc.) + Partner with Global Medical Affairs /product development, and global partners' subject matter experts to develop/execute disease… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... The Associate Director, Scientific Communications manages the execution of...consistency, and compliance. This position reports directly to the Senior Director, CNS Medical Communications Lead. **Key Responsibilities Include:**… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more