- Parexel (Annapolis, MD)
- …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 (Annapolis, MD)
- …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 (Annapolis, MD)
- …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
- Veterans Affairs, Veterans Health Administration (Baltimore, MD)
- …for inpatient professional coding and outpatient coding. With instruction from a senior coder or supervisor learns to select diagnosis, operation, or procedure codes ... social, and administrative data with guidance and instruction from supervisor or senior coder to develop knowledge of the organization and structure of an… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …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 (Annapolis, MD)
- …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. (Annapolis, MD)
- …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. (Annapolis, MD)
- …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
- Guidehouse (Hanover, MD)
- …FDA/ICH guidelines and CDISC data standards + Experience in pharmaceutical industry regulatory affairs and/or quality assurance and/or quality control + Direct ... research and technical evaluation panels. You'll also advise on clinical, regulatory , and manufacturing aspects of medical product development, ensuring alignment… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …a technical leader within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to ensure integrated quality ... **Job Summary** The Associate Director, Quality Operations will lead initiatives that...on key risk indicators and escalate critical risks to senior leadership. **Global Quality System Processes** + Oversee the… more