- Bristol Myers Squibb (Indianapolis, IN)
- …the global leader in radiopharmaceuticals . We are seeking an experienced and motivated ** Senior Director , Regulatory Affairs - CMC (Manufacturing)** . ... This position will report to the Head of Regulatory Affairs and will oversee and/or manage CMC regulatory functions within the RayzeBio manufacturing… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The Senior Director of Global Regulatory Affairs - CMC (GRA-CMC) leads and manages ... regulatory strategies for both development and commercial products. Additionally, the Senior Director is committed to encouraging continuous improvement in … more
- Lilly (Indianapolis, IN)
- …the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use CMC technical ... around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing...knowledge and regulatory science expertise to drive regulatory CMC… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs , Global Regulatory Lead (GRL) role ... and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructivelychallengeteams to reachthebest solutions… 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 ... the strategic leader, and a member of the Government Affairs Leadership Team, the Senior Director...Work with other relevant internal stakeholders (eg, Brand Teams, Regulatory Affairs , Market Access, Legal, Clinical) to… more
- United Therapeutics (Indianapolis, IN)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of...Ability to mentor, coach, guide, and train lower to senior level employees **Preferred Qualifications** + Proficient knowledge of… 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 ... experience, the Cardiometabolic Health Business Unit - Global Medical Affairs Sr. Director is an integral member...trials (for example, phase I and II trials). The Senior Director is responsible for the planning,… 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 ... drug discovery Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs , medical affairs ) If experience… 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 ... discovery Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs , medical affairs )** **If experience… more
- Sumitomo Pharma (Indianapolis, IN)
- …We are seeking a **strategic** , **experienced** **commercial leader** for the role of ** Senior Director , Orgovyx Brand Marketing Lead** . This is a high-impact ... performance, and maintaining its differentiated position in a competitive market. The Senior Director will lead a high-performing team of marketers spanning… more
- Lilly (Indianapolis, IN)
- …people who are determined to make life better for people around the world. ** Senior Director , Digital Legal Office - Health and Wellness Privacy Counsel** ... and strategic attorney with impeccable judgement who will provide legal and regulatory guidance on privacy issues related to health and wellness data collection… more
- Lilly (Indianapolis, IN)
- … regulatory compliance + Advanced degree or certifications in Quality Management, Regulatory Affairs , or related discipline + Proven track record of deploying ... make life better for people around the world. **About the Role:** The Director - Manufacturing & Quality, Training Globalization and Standardization will play a… more
- Lilly (Indianapolis, IN)
- …BU Medical, other MDU Functions, Clinical Development (early and late phase), Regulatory Affairs - North America and International, regional/affiliate brand ... make life better for people around the world. **Sr. Director / Executive Director - Safety Data...enable compliance, in an environment of continuous and disparate regulatory changes worldwide including: + Responsible for the development… more
- Bausch + Lomb (Indianapolis, IN)
- …global team members, other B&L departments (eg, R&D/Project Management, Clinical/Medical Affairs , Biometrics, Regulatory Affairs , Quality Assurance, ... study objectives are being met and provide the operations director and/or senior management with timely updates...timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house… more
- Merck (Indianapolis, IN)
- …ethics committees, and internal auditors in conjunction with CCQM, compliance, Regulatory , Pharmacovigilance (PV) and Medical Affairs . + Responsible and ... **Job Description** The Executive Director (ED) is the Clinical Operations lead in...& travel). + Country level operational study budgets. + Regulatory Inspections and internal audits; responding to inquiries by… more
- Lilly (Indianapolis, IN)
- …+ Experience in Manufacturing, Development, QC, Technical Services, Engineering and/or Regulatory Affairs . + Understanding of statistical tools and analysis. ... life better for people around the world. **Position Brand Description:** The Sr. Director - Quality - API (Peptide) External Manufacturing is the Site Quality… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …with cross-functional teams, including Brand Marketing, Sales, Patient Access, Medical Affairs , and Regulatory , to integrate pharmacy operations seamlessly into ... for OAPI The position will report to the Executive Director , Channel Strategy and Patient Affordability We are seeking...support, and engagement strategies. + Work with sales, medical affairs , and market access teams to ensure smooth integration… more
- Sumitomo Pharma (Indianapolis, IN)
- …the role of ** Director , HCP Marketing - Orgovyx** . Reporting to the Senior Director , Orgovyx Brand Marketing Lead, this individual will lead the HCP ... Medical Affairs , Market Access, Omnichannel, Patient Marketing, Legal, and Regulatory to ensure unified execution and strategic cohesion. + Lead co-promotional… more
- Lilly (Indianapolis, IN)
- …(DCRT), Therapeutic Area Teams, Drug Disposition, Product Development and Regulatory Affairs . **KEY OBJECTIVES/DELIVERABLES:** + Lead Medicinal Chemistry ... communicate equally well with employees, team members and cross-functional and/or senior leadership. Lilly is dedicated to helping individuals with disabilities to… more
- Fujifilm (Indianapolis, IN)
- …Risk Biomarkers sales through that community. As assigned interface with Senior Management teams from major IVD manufacturers. Maintain a comprehensive understanding ... reporting (Salesforce.com) + Where appropriate, collaborate with the Medical Affairs Team. + Follow up to define pathway and...all capital equipment i30 placements as directed by the Director of Sales and Marketing. + The territory is… more