- Bristol Myers Squibb (Indianapolis, IN)
- …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 facility located in… more
- Lilly (Indianapolis, IN)
- …are 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 scientific and regulatory efforts of the team, overseeing CMC ...Director is committed to encouraging continuous improvement in regulatory practices, operational efficiency, and personnel development within the… more
- Lilly (Indianapolis, IN)
- …over 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
- Merck (Indianapolis, IN)
- **Job Description** This position will be part of the Device Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The ... updates. + Audit vendors/partners of SaMD/IVD/Companion Diagnostics **Reports to** - Director Regulatory Compliance, Device Quality and Regulatory … more
- Merck (Indianapolis, IN)
- …Capability, People Leadership, Policy Implementation, Project Management, Project Tasks, Regulatory Affairs Compliance {+ 4 more} **Preferred Skills:** ... **Job Description** ** Director , Combination Product Regulatory CMC -...content or processes may also be required.Provide evaluations of regulatory state of affairs of any devices… 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 ... pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or… more
- Canon USA & Affiliates (Indianapolis, IN)
- … Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs , the Regulatory Affairs Specialist ... including MS Word, Excel, Oracle, Sales Force, etc. + 2 Years Regulatory Affairs experience in medical device industry required + Minimum Education Level: 2… 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) ... and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Constructivelychallengeteams to reachthebest solutions… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …brand objectives. Work with other relevant internal stakeholders (eg, Brand Teams, Regulatory Affairs , Market Access, Legal, Clinical) to help anticipate, ... We are seeking a Senior Director , Federal Government Affairs to lead...for in a multitude of public policy, legislative, and regulatory regimes and initiatives. Key Responsibilities Serve as the… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …value and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive medical ... disorders, we are seeking a skilled and experienced Medical Director of CNS Early Assets, Global Medical Affairs...or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical… 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 ... expertise, and relevant clinical experience, the Cardiometabolic Health Business Unit - Global Medical Affairs Sr. Director is an integral member of the medical … more
- CVS Health (Indianapolis, IN)
- …And we do it all with heart, each and every day. **State Government Affairs - Lead Director , State Government Affairs (Midwest United States)** ... CVS Health is currently hiring for a State Government Affairs Lead Director to join our dynamic...dynamic team. This role will direct and oversee Government Relations/ Regulatory Relations support for a primary business operation of… more
- Veterans Affairs, Veterans Health Administration (Fort Wayne, IN)
- …has both the authority and responsibility to represent both the Medical Center Director and the Chief, HAS on all administrative matters occurring when assigned to ... Delegated full authority and responsibility to exercise the Medical Center Director 's prerogative in medical administrative matters and issues that may arise.… more
- Veterans Affairs, Veterans Health Administration (Fort Wayne, IN)
- …vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Qualifications Basic Requirements: United States ... or supervised practice program and provide a verification statement from the program director that conveys eligibility to take the CDR registration exam as 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
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …to serve as an clinical/medical scientific consultant to health economic, medical affairs , marketing, regulatory , statistical and other research project team ... **Job Description** Otsuka is seeking a Director , Global Clinical Development (GCD), who will be responsible for the design and oversight of clinical research… 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, ... in an accurate and timely manner. + Provide Clinical Operations support to the Regulatory Affairs department. Leadership: + Manage in-house team of CRAs, CTAs… 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
- Wolters Kluwer (Indianapolis, IN)
- …device software launches and market expansions. **Post-Market Surveillance and Regulatory Affairs ** + Coordinate post-market activities including surveillance, ... upgrades to prevent future issues . Lead Auditor Certified, preferred . Regulatory Affairs Certification (RAC), preferred. **TRAVEL:** Travel is minimal and… more
- IQVIA (Indianapolis, IN)
- **MSL Associate Director ** We are excited to announce that currently we are looking for **Medical Science Liaison Associate Director and Player-Coach** with ... insight to inform decision making on various aligned teams. The **MSL Associate Director & Player Coach** will have all of the functional responsibilities of the… more