- Boston Biomedical, Inc. (Cambridge, MA)
- Associate Director , Regulatory Project Management is responsible for leading strategic planning and execution of the Regulatory and cross-functional ... outside the department necessary activities supporting submissions. Orchestrates and maintains regulatory project management information needed for project … more
- Novavax (Gaithersburg, MD)
- …We are seeking a highly motivated and experienced individual for a Director / Associate Director position in Regulatory Affairs. This position is located ... and BLAs, meeting requests, briefing packages, and responses to queries from regulatory agencies. Ensure that overall project timelines support the coordination… more
- AstraZeneca (Gaithersburg, MD)
- Join us as an Associate Director of Clinical Operations in Oncology late stage development, where you can be a part of turning exciting science and innovative ... this role, you will be responsible for leading the project planning and operational delivery of clinical work packages....oversight of a program of studies on behalf of Director Clinical Development (DCD) Provide clinical operations expertise into… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …that will one day help eliminate cancer as a cause of death. As an Associate Director of Project Management in the late stage Oncology organization, ... for leading cross functional drug development teams to achieve key development, regulatory and commercial milestones. You will be a champion for best-practices and… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- The Associate Director of Clinical Development (ADCD) is a core global role within the Clinical Operations function of Late Stage R&D (BioPharmaceuticals). The ... priorities and strategy. The ADCD will provide input & support to the Director of Clinical Development (DCD) in preparation for governance interactions. The ADCD may… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …hiring across a number of new positions in our Precision Medicine function. As an Associate Director or Director - Companion Diagnostic Expert you will play ... a Diagnostic Expert with experience at the Senior / Associate Director / Director level...leading Precision Medicine activities from a technical, financial, risk, regulatory , IP and partnering perspective.The role will involve contributing… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …the external environment whilst accessing and implementing innovative solutions. As an Associate Director and Programming Team Lead (PTL) within the Oncology ... along with the programming work required to deliver the requirements of a drug project (s). You will work collaboratively with both biometrics drug project team… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- Statistical Science Associate Director Payer Evidence - Oncology The role holder provides technical leadership as either an expert for a number of statistical ... the world. We have an exciting opportunity available for a Statistical Science Associate Director in our Gaithersburg Maryland Office or our Waltham,… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …as a cause of death in the future. We have an exciting opportunity for Associate Director Biostatistics, Late Oncology located in our Gaithersburg MD or Waltham ... statistical expertise for complex design and interpretation of clinical studies, regulatory submissions and commercialization. You will also act as a coach/guide… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …shaping the external environment whilst accessing and implementing innovative solutions.As an Associate Director and Programming Team Lead (PTL) within the early ... the programming contributions to internal decision making across phases including regulatory submissions and reporting and commercial activities for the portfolio of… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …position for late-stage formulation development of biologics responsible for project decisions and deliverables, scientific and organizational objectives, and people ... compatibility approaches and strategy. Review marketing applications and support regulatory responses to approval. Interface with stakeholders to ensure seamless… more
- Frederick National Laboratory for Cancer Research (Bethesda, MD)
- …Cancer Institute's Center for Cancer Research's (CCR) Office of the Clinical Director for protocol development review, regulatory review, and the implementation ... clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory , pharmacovigilance, protocol navigation and development, and programmatic and… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …required to fulfil the role of line manager to other Directors Scientific Project Management (DSPM) and/or Associate Directors Study Management (ADSM). You may ... by helping to generate the data required to drive regulatory submissions for new medicines and expanded indications and...Early Oncology ICA Group, vacancies have arisen for Group Director Clinical Programs (GDCP). In this role you are… more
- NAFSA: Association of International Educators (Washington, DC)
- Position Summary: The Human Resources Associate has direct responsibility for day-to-day administration of human resources programs. This generalist position ... changes to existing policies and procedures to ensure compliance with regulatory requirements. Manages document storage, retention, and destruction policies (10%)… more
- Takeda Pharmaceuticals (Lexington, MA)
- …company that will inspire you and empower you to shine? Join us as a Associate Director Regulatory Affairs Promo/Advertising in our Lexington, MA office. At ... will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: The Associate Director , US Medical Ad/Promo Regulatory Review serves as an… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …driving clinical development of novel innovative drugs in CVRM diseases.As an associate director clinical scientist your core accountability will be scientific ... support for the development and maintenance of project clinical strategies based upon your established expertise including the latest thinking about mechanisms of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …a vital contributor to our inspiring, bold mission. As an Associate Director /Senior Manager working on the Global Regulatory Affairs Oncology team, you will ... of your future at Takeda. Join us as an Associate Director /Senior Manager Advertising and Promotion-Oncology in...and a typical day will include: OBJECTIVE: Takeda in-house Regulatory specialist with a focus on product and disease… more
- AstraZeneca Pharmaceuticals (Gaithersburg, MD)
- …you can do - join us. Main Duties and Responsibilities Reporting to an Associate Director / Director within the Statistical Programming group you will lead ... and reporting process including, but not limited to, CSR development, regulatory submissions, commercialisation and the scientific utilisation of our data for… more
- Orchard Therapeutics (Menlo Park, CA)
- …date knowledge of regulatory CMC requirements and communicate changes in regulatory information to project teams and senior management Monitor, analyze, and ... Location: Menlo Park (US) Reporting to: VP Regulatory CMC Orchard Therapeutics Limited is a global...a cross-functional team environment with experience managing people and project teams; ability to work with remote teams Strong… more
- Takeda Pharmaceuticals (Cambridge, MA)
- OBJECTIVES/PURPOSE The Regulatory Informatics and Analytics Associate Director represents Global Regulatory Affairs as the busines owner of Regulatory ... is preferred. Experience managing vendors and contracts is strongly preferred. Project Management qualification is strongly preferred. Provides regulatory advice… more
