- 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
- 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 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
- 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
- Lilly (Indianapolis, IN)
- …or experience in drug discovery or development (eg, epidemiology, toxicology, pharmacovigilance, regulatory affairs ). + OR + BS degree (or equivalent experience) ... experience in drug discovery or development (eg, epidemiology, toxicology, pharmacovigilance, regulatory affairs ). + Experience in the drug development process… more