- 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
- 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
- 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
- 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
- Cengage Group (Indianapolis, IN)
- …To learn more, please see https://www.cengagegroup.com/about/inclusion-and-belonging/ . The **Senior Director of** **State** **Government Affairs ** will be ... Communications Officer and work in partnership with the Sr Director of Federal Government Affairs in addition...+ Use your deep knowledge of state legislative and regulatory processes to create strategies for effective engagement that… 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
- 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)
- …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 the...teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory , Commercial). **Content Execution Direction** + Provide guidance, coaching,… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- **Job Summary** The Director , Medical Communications directs Leads and manages the execution of the global and US scientific communication for the global and US ... ensure scientific accuracy, consistency, and alignment with the overall Rare Disease Medical Affairs strategy. The role is a key leadership position within the Rare… 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)
- The Medical Director , Nephrology & Immunology Medical Strategy is a critical role responsible for shaping the strategic processes and planning for assets in early ... ability to balance competing priorities. This position reports directly to the Senior Director , Immunology Lead, who in turn reports to the Executive Director ,… 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
- 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
- Lilly (Indianapolis, IN)
- …functional teams including Case Management and Clinical Operations, Commercial teams, Medical Affairs , and Regulatory functions to ensure seamless integration of ... life better for people around the world. **Job Responsibilities:** The Sr. Director PV Case Management ICSR provides technical leadership for the design,… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …lead a cross-functional team, working closely with market access, sales, medical affairs , regulatory , and commercial excellence to align on strategic priorities ... **_Sr. Director , Brand Lead, Neuroscience_** **Position Summary** The Senior...pull-through execution. + **Cross-Functional Leadership:** Collaborate closely with medical, regulatory , commercial operations, and finance teams to ensure cohesive… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- **Job Summary** The Associate Director , R&D HCP Engagement CoE is a critical change agent and system implementer responsible for designing the operating model and ... 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