- CBRE (Indianapolis, IN)
- Regulatory Change Management Director Job ID 215809 Posted 21-Apr-2025 Service line Corporate Segment Role type Full-time Areas of Interest Legal ... - Remote - US - United States of America **About The Role:** As a Regulatory Change Management Director at CBRE, you will be responsible for developing… more
- Bristol Myers Squibb (Indianapolis, IN)
- …Controls for global impact and guide technical teams on global change management + Provide additional ad hoc Regulatory -CMC support to RayzeBio manufacturing ... radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will report to… more
- United Therapeutics (Indianapolis, IN)
- …like lungs, pancreases and hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory pathways, managing documentation and ... timelines, and supporting the preparation and execution of regulatory submissions for our whole organ tissue engineering program. Are you looking to fundamentally … more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Responsibilities** The Senior Director , Global Process Owner for Document Management , as a leader within ... standards, industry trends and scientific principles. **Key Objectives/Deliverables** The Senior Director , Global Process Owner for Document Management is… more
- Lilly (Indianapolis, IN)
- …are determined to make life better for people around the world. Overview: The Senior Director , Global Quality - Supplier and Materials Management , is a member of ... standards as well as ensuring standard approaches across the networks.Support periodic management reviews of supplier performance. + Regulatory Compliance: Stay… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …personnel management experience, will support position at entry (Associate Director / Director ). + An advanced understanding of drug development principles and ... **Job Description** Otsuka is seeking a Director , Global Clinical Development (GCD), who will be responsible for the design and oversight of clinical research… more
- Lilly (Indianapolis, IN)
- …, etc.). **Other Information/Additional Preferences:** + Experience in Pharmacovigilance/Clinical/ Regulatory systems, technologies and associated processes for which ... people around the world. The purpose of the Sr. Director - Safety Data Scientist role is to provide...etc.) + Demonstrated strategic thinking skills and driving broad change . + Process Management experience and exceptional… more
- Cardinal Health (Indianapolis, IN)
- …- leading providers of medical supplies direct-to-home. **Position Summary:** The ** Director of Document Management & Revenue Integrity** is responsible ... for leading and overseeing all aspects of document lifecycle management within ADSG and Edgepark. This includes document intake, storage, retrieval, compliance, form… more
- Lilly (Plainfield, IN)
- …Engineering team to ensure compliance to HSE portions of new asset delivery and change management (Risk Assessments, FMEAs, Design Reviews) + Represent NALO in ... + Knowledge of cGMP, Trackwise (QMS), and GMARS (CMMS). + Experience with change management , deviation management , periodic reviews, routine data monitoring… more
- Lilly (Indianapolis, IN)
- …between the CM's and Lilly's quality systems (eg, deviations, complaints, change management ) via day-to-day interactions and maintaining Quality Agreements. ... to CMs, including maintaining and improving compliant oversight practices. + Support regulatory agency inspections at the CM, provide management status updates… more
- Lilly (Indianapolis, IN)
- …is embedded within the broader Quality Management System (QMS), including CAPA, change control, and audit readiness. + Regulatory Intelligence & Risk ... to those who need them, improve the understanding and management of disease, and give back to our communities...world. We are seeking a strategic and experienced Senior Director of Drug Supply Chain Security Act (DSCSA) Compliance… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- We are seeking a Senior Director , Federal Government Affairs to lead our US federal government engagement in Washington, DC. This position reports to the Vice ... member of the Government Affairs Leadership Team, the Senior Director of the Federal Government Affairs will play an...for in a multitude of public policy, legislative, and regulatory regimes and initiatives. Key Responsibilities Serve as the… more
- Lilly (Indianapolis, IN)
- …bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and ... bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …those with CNS disorders, we are seeking a skilled and experienced Medical Director of CNS Early Assets, Global Medical Affairs, responsible for certain assets ... TA which align to the broader overall TA strategy determined by the Sr. Director , Franchise Lead CNS Early Assets. **Position Summary:** The Medical Director ,… more
- Lilly (Indianapolis, IN)
- …bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and ... people around the world. The purpose of the Sr Director , GPS Medical role is to be responsible for...therapeutic areas. This role requires strong leadership, guidance, and management of a global group of therapeutically aligned physicians… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …nutraceutical products for the maintenance of everyday health As a Director , Quantitative Pharmacology, **Clinical Pharmacology,** you will oversee all **clinical ... pre-IND, IND, phase1-3, **Pharmacokinetics** **(PK)** , **Pharmacokinetics-Pharmacodynamics (PK/PD)** and regulatory submissions. You will lead study design, execution and… more
- Lilly (Indianapolis, IN)
- …and process validation experience. + Previous experience with deviation and change management systems including Trackwise. + Responsible for maintaining ... approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and… more
- Evolent (Indianapolis, IN)
- …training classes as needed for new hires to educate and train on Utilization management system and Field Medical Director process, standards and resources. + ... for the culture. **What You'll Be Doing:** The Medical Director for MSK Surgery is a key member of...Surgery Field Medical Directors and interacts with leadership and management staff as well as health plan members and… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible for all ... understanding of drug development principles and clinical trial implementation and management . + Complete understanding of the global regulatory requirements.… more
- Wolters Kluwer (Indianapolis, IN)
- …/failure effect modes analysis (FMEA) activities for device software. + Drive change management process for device software launches and market expansions. ... in Wolters Kluwer. Important responsibilities include cross-functional correspondence, quality management reviews, audit support, change planning, and corrective… more