- 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 ... regulatory approval. + Monitor and report on international regulatory developments and LDT requirements that...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… 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
- Lilly (Indianapolis, IN)
- …with internal business partners including clinical teams, commercial teams, legal, regulatory affairs , ethics and compliance, and other relevant functions. ... life better for people around the world. The Senior Director of Gene Therapy Medical Affairs will...to travel approximately 40% including weekend commitments. May include international travel. Lilly is dedicated to helping individuals with… 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
- 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) ... leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participate in forums that share … more
- Veterans Affairs, Veterans Health Administration (Fort Wayne, IN)
- …equitable patient care. Ensures compliance with accreditation and regulatory standards. Aligns nursing/clinical objectives with organizational strategic outcomes, ... mission. The NM maintains knowledge and ensures compliance with all regulatory and accreditation standards, Directives, policies, and standard operating procedures… 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)
- **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
- 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
