- 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
- Merck (Indianapolis, IN)
- …Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development ... control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices and combination products, for due diligence… 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
- 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
- Merck (Indianapolis, IN)
- **Job Description** **Role Summary** + The Health Systems Medical Affairs Director (HS MAD) is a therapeutic and disease expert who develops ongoing professional ... in a balanced and credible manner consistent with the regulatory environment and company's ethical standards. This role also...resource for the HS MAD Team Lead, HS Executive Director Medical Affairs , and other members of… 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
- Lilly (Indianapolis, IN)
- …The Associate Vice President (AVP) - Cardiometabolic Health Global Medical Affairs drives strategic planning and, through clinical plans managers, team leaders, ... may delegate some of his/her duties to a Senior Director - Medical. In addition, he/she is responsible for...the strategic priorities of the Cardiometabolic Health Global Medical Affairs team(s), brand team(s), and global Development team(s), and… more
- Takeda Pharmaceuticals (Indianapolis, IN)
- … Project Management and Strategic Planning - Neuroscience 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
- Takeda Pharmaceuticals (Indianapolis, IN)
- …innovative opportunities to improve processes and infrastructure in line with global regulatory expectations and Global Regulatory Affairs (GRA) technology ... goals. + Demonstrates leadership and a deep understanding of global regulatory affairs (GRA) information/data regulations and guidelines, proactively addressing… 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)
- …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
- 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
- Takeda Pharmaceuticals (Indianapolis, IN)
- …Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, coordinates the process to ... plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a key role in the PDT… more
- Sumitomo Pharma (Indianapolis, IN)
- …. **Job Overview** Director , MSL Lead, Oncology ... 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
- Takeda Pharmaceuticals (Indianapolis, IN)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for the development ... and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Lilly (Indianapolis, IN)
- …additional items including but not limited to protocols, publications, regulatory interactions, internal executive and governance presentations, external key opinion ... Understand how design elements influence the ability to deliver on new regulatory expectations (eg decentralization of clinical trials, increase racial and ethnic… more