- Sumitomo Pharma (Indianapolis, IN)
- …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...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead (GRL) ... leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructively challenge teams to reach… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs , Global Regulatory Lead (GRL) ... behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participate in forums that share regulatory … more
- GRAIL (Indianapolis, IN)
- …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
- Cardinal Health (Indianapolis, IN)
- …joins a team of medical affairs professionals who report to the Sr Director of Regulatory & Medical Affairs . **Responsibilities:** + Collaborate across ... hours. We also provide customers the support they need in regulatory compliance, reimbursement, continuing education, information management and other crucial areas,… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- As a senior leader within Medical Affairs , the Executive Director will serve as a strategic thought partner and Chief of Staff to the Vice President of Medical ... capabilities aligned with Otsuka's vision, direction, and growth strategy. The Executive Director , Medical Affairs Strategy, Excellence & Operations will lead… more
- Lilly (Indianapolis, IN)
- …"patient journey" and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies (medical support for ... clinical experience, the Cardiovascular/Cardiometabolic Business Unit - Global Medical Affairs Clinical Research Physician (CRP) Senior/Executive Director is… more
- Oracle (Indianapolis, IN)
- **Job Description** Fortune 100 information technology company seeks a Director , State and Local Government Affairs , reporting to the Vice President, State ... Government Affairs . The Director , State and Local Government Affairs will...state and local officials including executive and legislative branch, regulatory officials, municipal government and other relevant stakeholders. +… more
- Merck (Indianapolis, IN)
- **Job Description** The US Director of Medical Affairs (DMA) for Gynecologic Malignancies (Ovarian, Endometrial and Cervical Cancer) holds primary responsibility ... for the development and execution of regional oncology Medical Affairs strategies and plans for Gynecological Malignancies in the...interactions with Patient Advocacy Groups + Tracks guidelines and regulatory landscape in the US region + Review of… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. Job Description **Senior Director - Cardiometabolic Health Global Medical Affairs ,** **CV Outcomes/NILEX HEOR ... to increase. The purpose of the Cardiometabolic Health (CMH) Global Medical Affairs , Cardiovascular (CV) Outcomes/New Indication Line Extension (NILEX) HEOR team is… more
- State of Indiana (Indianapolis, IN)
- Executive Director of Legislative and Intergovernmental Affairs Date Posted: Nov 24, 2025 Requisition ID: 468224 Location: Indianapolis, IN, US, 46204 Work for ... this position is to lead the agency's engagement with legislative and regulatory bodies, protect state autonomy within a cooperative federalism framework and develop… more
- Lilly (Indianapolis, IN)
- …with internal business partners including clinical teams, commercial teams, legal, regulatory affairs , ethics and compliance, and other relevant functions. ... make life better for people around the world. The Senior Director of Gene Therapy Medical Affairs will work across our gene therapy portfolio in multiple… more
- Lilly (Indianapolis, IN)
- …- Implementing global clinical trials in local affiliates/countries. - Ensuring regulatory compliance and safety reporting. - Supporting pricing, reimbursement, and ... selection. - Ensure completion of ethical review board, informed consent, and regulatory approvals consistent with GCPs and local laws. - Provide scientific training… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …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 the...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... The Senior Director , Medical Communications, CNS directs and provides strategic...accuracy, consistency, and alignment with the overall CNS Medical Affairs strategy. The role is a key leadership position… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- The Associate Director , Congress and Medical Education Strategy & Execution is responsible for executing and contributing to the global medical strategy and tactical ... through deep scientific understanding and collaborative partnerships. The Associate Director partners closely with global and regional cross-functional stakeholders… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- **Job Summary** The Senior Director , Medical Communications, Nephrology & Immunology directs and provides strategic leadership for the global scientific ... accuracy, consistency, and alignment with the overall Nephrology & Immunology Medical Affairs strategy. The role is a key leadership position within the Nephrology… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …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
- Lilly (Indianapolis, IN)
- …disciplines: TSMS, Production, Quality Assurance, Quality Control, Engineering, or Regulatory Affairs . **Additional Skills/Preferences:** + Responsible for ... better for people around the world. #WeAreLilly **Responsibilities:** The Associate Director - Quality Assurance (QA) API External Manufacturing is responsible for… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. + Provides ... with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD...trials and regulatory filing activities. The Senior Director , GCD is responsible for all the clinical development… more