- 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
- Humana (Washington, DC)
- …help us put health first** The role of Director, Federal Government Affairs involves direct engagement with Senate, House, and/or Administration officials and staff ... years of professional experience in Senate, House, Administration, government affairs , campaign, health policy and/or advocacy roles. Positions within committee,… 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
- Amgen (Washington, DC)
- …12 years of directly related experience **Preferred Qualifications:** + Experience with regulatory documents in Regulatory Affairs , Research, Development or ... time for a career you can be proud of. ** Regulatory Writing Senior Manager** **Live** **What you...degree and 8 years of directly related experience OR Associate 's degree and 10 years of directly related experience… 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
- Amgen (Washington, DC)
- …transform the lives of patients while transforming your career. **Advocacy Relations Senior Manager, Respiratory** **What you will do** Let's do this. Let's change ... the world. In this vital role the Advocacy Relations Senior Manager, Respiratory will lead the execution of Amgen's...on education and access. + Partner closely with Medical Affairs , Commercial, Access, Corporate Affairs , Government … more
- Internal Revenue Service (Washington, DC)
- …Careers Site Meet Our People Learn about our Legal Divisions Responsibilities The Senior Level Counsel (SLC) serves as a national expert and confidential advisor, to ... the Associate Chief Counsel, Procedure and Administration (P&A); and represents...the highest complexity and impact. Major duties of the Senior Level Counsel include, but are not limited to… 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
- Amgen (Washington, DC)
- …patients while transforming your career. **Health Economics & Outcomes Research (HEOR) Senior Manager, Oncology** **What you will do** Reporting to the HEOR ... Director, the HEOR Senior Manager is accountable for executing on the HEOR...and cross-functional teams: Evidence Generation Team (EGT), Global Medical Affairs Team (GMAT), Center for Observational Research, Access and… 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
- 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
- Newell Brands (Annapolis, MD)
- …a related field. + 3-5 years of experience in tax incentives, government programs, regulatory affairs , or a related area (internships or co-op experience may be ... and collaborative environment where you can be your best, every day. The Associate Manager, Tax Incentives & Grants will support the Manager in identifying,… more
- KeenLogic (Alexandria, VA)
- …7 years of experience. + Experience in IT support, compliance management, or regulatory affairs . + Strong troubleshooting and technical skills. + Knowledge of ... Qualifications: + Bachelor's degree and 3 years of experience, Associate 's degree and 5 years of experience, or High...ongoing compliance. + Report compliance status and issues to senior management. + Provide training and guidance on compliance… more