- Sumitomo Pharma (Indianapolis, IN)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs ** . The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will...pharmaceutical industry with minimum of 6 years focused in Regulatory Affairs + Include the qualifications preferred… more
- Sumitomo Pharma (Indianapolis, IN)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …application is true to the best of my knowledge. **Job Description** The Regulatory Affairs -Labeling, Associate Director is responsible for ensuring that ... pertaining to global and local labeling compliance and quality within Global Regulatory Affairs . + Partners with internal stakeholders and external CRO… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and… more
- Lilly (Indianapolis, IN)
- …tactical, and operational support for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC ... for people around the world. Lilly is looking for regulatory Chemistry, Manufacturing and Control (CMC) scientists to join...need them all over the world. We are seeking Regulatory Scientist GRA-CMC to be a part of the… more
- Lilly (Indianapolis, IN)
- …from an accredited college or university + At least 5 years of regulatory affairs experience with research-based drug development, including early phase (first ... Ph1/Ph2) submission experience. + Demonstrated understanding of clinical drug development and regulatory affairs , including regulations in the US, UK, EU, and… more
- Sumitomo Pharma (Indianapolis, IN)
- …website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Director , Medical Affairs Strategy (Hematology/Oncology) will be a key ... member of the Medical Affairs team reporting to the Executive Director ,...confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring… more
- Sumitomo Pharma (Indianapolis, IN)
- …Director , Medical Strategy (Rare Disease) will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... company programs and external facing HCP and Payer interactions. The Sr. Director of Medical Affairs develops and maintains professional relationships with… more
- Sumitomo Pharma (Indianapolis, IN)
- …, Medical Strategy (Prostate Cancer)** will be a key member of the Medical Affairs team reporting to the Executive Director , Medical Affairs Strategy. ... initiatives and advance patient advocacy efforts to ensure that Medical Affairs activities align with patient focused programs. **Job Duties and Responsibilities**… more
- Sumitomo Pharma (Indianapolis, IN)
- …. **Job Overview** Director , Field Medical and ... summarizes, and disseminates key insights obtained from the RDs to the Medical Affairs and other internal stakeholders in a timely manner. + Participate in the… more
- Lilly (Indianapolis, IN)
- …journey " and the strategic plan for the compound ), medical support for regulatory affairs and interactions with government agencies (medical support for New ... position is $252,000 - $369,600 Clinical Research Physician - Medical Affairs , Neuroscience Business Unit, Psychiatry Purpose: Through the application of scientific… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- …Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global ... changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global Regulatory Project Management… more
- Merck (Indianapolis, IN)
- …+ Stay updated on emerging regulations and industry trends affecting device quality and regulatory affairs . Strategic Contributions + Serve as a key member of ... **Job Description** The Executive Director , Device Quality & Regulatory will...+ 10+ years of experience in device quality, device regulatory affairs , or a related field within… more
- United Therapeutics (Indianapolis, IN)
- …primarily responsible for providing expert legal support to Marketing, Sales, Medical Affairs , Patient Relations, Regulatory Affairs and Corporate ... Company's various products. + Provide guidance to Sales, Marketing, Medical Affairs , Patient Relations, Regulatory and Corporate Compliance departments related… more
- Veterans Affairs, Veterans Health Administration (Indianapolis, IN)
- …Medical Supply Technician (MST), Sterile Processing Service (SPS) under the Associate Director for Patient Care Services. The incumbent functions as a sterile ... influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Participation in the Coronavirus Disease 2019… more
- Veterans Affairs, Veterans Health Administration (Indianapolis, IN)
- …transportation. The work may require occasional use of Department of Veterans Affairs approved behavioral management techniques with Veterans who present a danger to ... promoted to the full performance level without further competition when all regulatory , qualification, and performance requirements are met. Selection at a lower… more
- Veterans Affairs, Veterans Health Administration (Indianapolis, IN)
- …influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Participation in the Coronavirus Disease 2019 ... 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
- Sumitomo Pharma (Indianapolis, IN)
- …. **Job Overview** The **Executive Director Head of Medical Strategy** will ... be a key member of the Medical Affairs Leadership team reporting to the Vice President,...confidential. **Compliance** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and procedures, by ensuring… more
- Lilly (Indianapolis, IN)
- …and Access Programs is accountable for partnering with drug development teams, Global Regulatory Affairs (GRA), Clinical, CM&C, and the broader Product Delivery ... areas: pharmacy, drug development, clinical drug development, CT material, CM&C, global regulatory affairs , quality, or commercial manufacturing + Licenses or… more
- Wolters Kluwer (Indianapolis, IN)
- The Consulting Associate Director works directly with our Sentri7 Drug Diversion customers and Customer Success Managers to optimize use of the application, ... collaborates with our Clinical Affairs Team in support of these customers and shares...feedback with our product management team. The Consulting Associate Director work will include technical consulting such as product… more