- 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 review of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties as assigned. **Required… more
- Sumitomo Pharma (Annapolis, MD)
- …currently 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 primarily function as a regional regulatory leader… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to ... + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and strengthen and… more
- United Therapeutics (Annapolis, MD)
- …that UT data is approved and ready for field use following presentation. Associate Medical Excellence & Training Director Minimum Requirements + Bachelor's ... (slides, FAQ, talking points etc.) + Partner with Global Medical Affairs /product development, and global partners' subject matter experts to develop/execute disease… more
- Veterans Affairs, Veterans Health Administration (Baltimore, MD)
- …Staff and serves as a key clinical resource for the Medical Center Director and the Chief of Staff. Responsibilities The responsibilities include hands-on clinical ... ability to meet standards issued by various accrediting and regulatory groups and VACO. D. Research and Education Encourages...findings into improved patient outcomes. Works closely with the Associate Chief of Staff for Research and the … more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- The Associate Director , Scientific Communications manages the execution of the core scientific and medical communications strategy for the relevant therapeutic ... accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs ,… more
- Veterans Affairs, Veterans Health Administration (Baltimore, MD)
- …and evaluation of individual staff performance. The NM is accountable to the Associate Director of Patient Care Services (ADPCS). Responsibilities The Nurse ... and equitable patient care. Ensure compliance with accreditation and regulatory standards. Align nursing/clinical objectives with organizational strategic outcomes,… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …needs and nutraceutical products for the maintenance of everyday health. As an Associate Director , Biostatistician, you will be a champion of Otsuka's culture ... statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues,… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- **Job Summary** The Associate Director , R&D HCP Engagement CoE is a critical change agent and system implementer responsible for designing the operating model ... to a direct report responsible for day-to-day execution. While initially focusing on Medical Affairs , the vision is to cover all R&D HCP engagement over time. This… more
- Guidehouse (Hanover, MD)
- …Software, Assay chemistry, microbiology, virology, immunology **_Programmatic/Technical Advisor_** - Associate Director + **Doctoral degree** in biological ... FDA/ICH guidelines and CDISC data standards + Experience in pharmaceutical industry regulatory affairs and/or quality assurance and/or quality control + Direct… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- **Job Summary** The Associate Director , Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and ... leader within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to ensure integrated quality operations. +… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company's global ... outcomes. + **Cross-Functional Collaboration** + Collaborate with Procurement, Manufacturing, Regulatory Affairs , and Technical Operations to ensure supplier… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product ... all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …to address strategic objectives to business partners. + Work closely with medical affairs , marketing, and IT teams to ensure alignment and integration of omnichannel ... Research, Analytics, Otsuka Information Technology (OIT), Sales Operations, and Medical/ Regulatory /Legal integrated business partners. **Minimum Qualification:** + Bachelor's degree… more
- Johns Hopkins University (Baltimore, MD)
- …A minimum of 10 years of relevant experience in educational program compliance, legal/ regulatory affairs , or related roles within a higher education or ... Executive Director of Educational Program Compliance, JHUSOM Compliance Office...is also responsible for monitoring the evolving legal and regulatory enforcement landscape under all applicable laws and regulations.… more
- University of Maryland, Baltimore (Baltimore, MD)
- …in the MS in Regulatory Science program, with a focus on introductory and regulatory affairs aspects of the program, as well as another aspect of the program ... AREAS OF EXPERTISE AND EXPERIENCE_* Regulatory science, including introductory and regulatory affairs aspects, as well deep knowledge in another aspect (eg… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …internal and external regulations. This position reports directly to the Associate Director , CNS Scientific Communications. **Job Description** **Key ... Include:** **Core Content Development** + Under the guidance of the Associate Director , Medical Communications, draft and maintain high-priority, foundational… more
- Johns Hopkins University (Baltimore, MD)
- …In collaboration with the Director of Surgical Pathology and the Deputy Director for Quality and Regulatory Affairs , the Division Director ... School of Medicine seeks a dynamic physician-leader at the Associate Professor or Professor level to serve as Division... Professor or Professor level to serve as Division Director of Breast Pathology. This individual will lead a… more
- Sumitomo Pharma (Annapolis, MD)
- …Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director , Clinical Business Operations, the specialist ensures accountable ... system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as… more
