- Lupin Pharmaceuticals (Coral Springs, FL)
- … regulatory success etc.Provide expert recommendations based on scientific and medical analysis. Regulatory Compliance: Ensure adherence to FDA guidelines for ... 505(b)(2) applications and other regulatory standards.Addressing medical /clinical queries from health authorities. Leadership and Collaboration: Lead… more
- Novo Nordisk Inc. (Minneapolis, MN)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Insmed Incorporated (NJ)
- …You Are:You have a Bachelor's degree along with 5+ years of experience in Medical Affairs, Regulatory Affairs, or related functions within the pharmaceutical or ... future of science, we're in. Are you?About the Role:The Associate Director, Medical Review Committee (MRC) Operations is responsible for managing the operational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Insmed Incorporated (NJ)
- …experience E xpert knowledge of relevant guidelines including, but not limited to medical and regulatory affairs, drug development, FDA and regulatory ... the future of science, we're in. Are you?About the Role:The Senior Director, Medical Services will provide strategic leadership to Insmed's independent medical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pharmaceutical industry required Proven knowledge of the pharmaceutical industry, including medical , regulatory , clinical processes and market dynamics, within ... engagement across NN USO. They will be accountable for KOL and medical association identification, planning, and engagement strategies. They will develop competitive… more
- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- …field. Minimum experience required: 5 years of relevant experience in GMP, medical devices, or pharmaceuticals, preferably within a Regulatory -related field, ... Quality Assurance & Regulatory Manager Valencia & Burbank, CA Company Benefits...Valencia & Burbank, CA Company Benefits 100% employer paid medical and dental 401(k) matching contribution Generous PTO and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to drive patient initiatives. Requires experience and collaboration with the Medical , Regulatory and Legal review process. Essential Functions Develops ... teams to achieve shared goals Extensive experience with the Medical , Legal, Regulatory review process with a deep understanding of compliance and… more
- Insmed Incorporated (NJ)
- …experience in IT with focus on healthcare/pharmaceutical industryExperience with medical affairs processes and regulatory environmentsStrong technical knowledge ... of science, we're in. Are you?About the Role:The IT Business Partner for Medical Affairs and Innovation serves as a strategic liaison between Information Technology… more
- Merck & Co. (Boston, MA)
- …Phase 2-3) including study design, medical monitoring, and medical /scientific interpretation of study analyses,- regulatory reporting, and publication.-The ... Disease, Infectious Disease Research, Intellectual Curiosity, Interdisciplinary Problem Solving, Medical Research, Pharmacovigilance, Regulatory Compliance, Regulatory… more
- Insmed Incorporated (San Diego, CA)
- …will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety, and quality assurance teams, as ... support and work predominately with the Clinical Trial/Indication Lead(s) and Medical Monitor(s) for assigned protocols and/or projects, partnering with vendors and… more
- Cipla (Fall River, MA)
- …committee, commercial, portfolio, R&D technical staff, supply chain management, medical affairs, regulatory affairs, quality assurance, procurement etc. ... to include a 401(k) savings plan and matching, health insurance - medical /dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off… more
- Jupiter Medical Center (Jupiter, FL)
- …Director will provide direct patient care, mentor staff, and ensure compliance with regulatory standards. Qualifications Medical degree (MD or DO) and board ... Jupiter Medical Center, the only independent, not for profit...its region with a 4-star rating from CMS, Jupiter Medical Center is renowned for its outstanding physicians, state-of-the-art… more
- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs, Tactical Implementation, on the Regulatory Affairs team to help ... for patients with serious diseases. Reporting to the Associate Director, Regulatory Affairs, Tactical Implementation, you'll have a critical role in hands-on… more
- Merck & Co. (Rahway, NJ)
- …and supply. A key workstream within this initiative is the auto-generation of regulatory filing sections, enabled by a dedicated application designed to create a ... frictionless flow of data from source systems to regulatory documentation.- - - Under the guidance of dCMC Regulatory Authoring Leadership, the Senior… more
- Insmed Incorporated (NJ)
- …future of science, we're in. Are you?About the Role:We're looking for an Associate, Regulatory Operations on the Regulatory team to help us expand what's ... for patients with serious diseases. Reporting to the Executive Director, Regulatory Operations, you'll be responsible for the publishing, management, and submission… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... we want to hear from you. The Director, Global Regulatory , Growth Markets will be responsible for providing ...Regulatory , Growth Markets will be responsible for providing regulatory leadership and strategic direction for Eisai's products in… more
- Insmed Incorporated (NJ)
- …for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global ... regulatory strategies and plans to enable efficient, competitive product...your team, and yourself.Highlights of our US offerings include:Comprehensive medical , dental, and vision coverage and mental health support,… more
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