- Bristol Myers Squibb (Indianapolis, IN)
- …team, RayzeBio aims to be the global leader in radiopharmaceuticals . Associate Director of Regulatory Project Management will plan, execute and oversee ... + Bachelor's degree or higher + A minimum of 7 years of experience in regulatory project management + Hands-on experience with NDA filing is a must + Oncology … 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....a related area of study + 8+ years of project or people management experience + Must have written… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages the ... Director is committed to encouraging continuous improvement in regulatory practices, operational efficiency, and personnel development within the GRA-CMC… more
- Lilly (Plainfield, IN)
- …make life better for people around the world. **_What You will do:_** The Associate Director of Safety and Maintenance supports the North American Logistics ... Operations (NALO) organization, reporting to the Associate Director of Engineering and Maintenance for NALO. The role supports internal US distribution centers… more
- Lilly (Lebanon, IN)
- …to enable a successful startup into GMP manufacturing operations. **Description:** The Associate Director (AD) - Process Safety Engineering is responsible for ... tank farms, utilities, waste operations, laboratories, and administrative facilities. The Associate Director - Process Safety Engineering works closely with… more
- Lilly (Lebanon, IN)
- …a successful startup into GMP manufacturing operations._ **Position Description:** The ** Associate Director Process Engineering - Small Molecule Active ... in the manufacturing of small molecule products. Additionally, the Associate Director of Process Engineering - Small...business plan priorities, and compliance plan objectives. In the project delivery phase and startup phase of the … more
- Lilly (Indianapolis, IN)
- …develop creative solutions to support communities through philanthropy and volunteerism. The Associate Director , International Tax is a key role within Lilly's ... tax team. The Associate Director fulfills important leadership responsibilities for...interesting projects including monitoring and analyzing US and foreign regulatory environment, supporting audit controversy defense, and advising regarding… more
- Lilly (Indianapolis, IN)
- …days remote - a generous relocation package can be included with offer The ** Associate Director - Submission Data Delivery** role leads all aspects of global ... data archiving, data standards, and submission process. **Responsibilities:** The Associate Director -Submission Data Delivery provides technical leadership and… more
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. ** Associate Director - Digital Engineering Solutions** **Organization Overview:** At Lilly, ... twins, computational modeling, edge/IoT, and analytics solutions. **Responsibilities:** The Associate Director - Digital Engineering Solutions position, within… more
- Lilly (Indianapolis, IN)
- …program ownership for key programs across the corporation. **Position Overview:** The Associate Director - Corporate Mechanical Disciplines position has overall ... supporting the overall corporate design, delivery, and equipment strategies. The Associate Director role will provide mechanical engineering discipline… more
- Sumitomo Pharma (Indianapolis, IN)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Medical Director .** The Associate Medical Director ... and manages Safety Charters + Handles Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries. + Represents PVRM on post-marketing product specific and/or… more
- Lilly (Indianapolis, IN)
- …behaviors to develop medicines with safety first and quality always. The Associate Director - Technical Services/Manufacturing Science (TSMS) Visual Inspection ... classification, control strategies, validation strategies, and personnel qualification strategies. The Associate Director - TS/MS Visual Inspection must balance… more
- Sumitomo Pharma (Indianapolis, IN)
- …Overview** We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical pharmacology, and ... drug metabolism and bioanalytic chemistry. This position will report to Senior Director of Clinical Pharmacology and Drug Metabolism. S/he will work across… more
- Lilly (Indianapolis, IN)
- …and innovative ways to accelerate reach and scale for a life-changing medicine! The Associate Director - Chronic Weight NILEX and Special Projects will play a ... unique mix of marketing, business strategy, analytical analysis, and project management which will require ambitious thinking, comfort with...of a therapy broadly appealing and widely available. The Associate Director - US Chronic Weight NILEX… more
- Lilly (Indianapolis, IN)
- …to develop medicines with safety first and quality always. The TS/MS Associate Director is responsible leading/mentoring a technical staff and understanding ... disciplines such as Manufacturing, Quality Control, Quality Assurance, Advanced Project Management, Development, Regulatory Sciences or Engineering. **Additional… more
- Bristol Myers Squibb (Indianapolis, IN)
- …team, RayzeBio aims to be the global leader in radiopharmaceuticals. **Job Description** The Associate Director , IT Digital Plant & Projects is an integral part ... patients in need. In this role, you will report directly to the Exec. Director , IT and be primarily responsible implementing RayzeBio's vision for growth and leading… more
- Lilly (Indianapolis, IN)
- …creative solutions to support communities through philanthropy and volunteerism. The Associate Director Clinical Development, Oncology independently leads the ... on trials with quality, on time, and within scope and budget. The Associate Director consistently demonstrates leadership and influence throughout the trial… more
- Lilly (Indianapolis, IN)
- …molding and assembly equipment builders, and contract manufacturers) to develop integrated project schedules for new products and assets. The role will focus on ... gaps + Manage resource workload and allocation across the entire project portfolio + Optimize organizational design/structure and recommendations for the business… more
- Lilly (Indianapolis, IN)
- …to support communities through philanthropy and volunteerism. **Purpose:** The purpose of the Associate Director - Data Standards role is to be responsible for ... CDISC) and facilitate mapping between internal and external data standards for regulatory submissions and when dealing with vendors and other third parties. _Process… more
- Lilly (Indianapolis, IN)
- …+ Determine when to apply Agile and/or Waterfall techniques to manage project timelines, resources, and deliverables effectively. + GxP Compliance: Ensure all ... adhere to GxP standards, maintaining the highest levels of quality and regulatory compliance. + Stakeholder Management: Engage with stakeholders at all levels,… more