- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director, Regulatory Affairs lead is responsible for developing and ... and marketing Formation Bio's assets. This role includes the lead regulatory responsibility for support of global...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Insmed Incorporated (NJ)
- …medical team.Experience partnering with the HEOR group.Proven understanding of legal, regulatory , and compliance policies.Demands a keen understanding of ... future of science, we're in. Are you?About the Role:The Medical Director, Medical Affairs - Dermatology role will be responsible for supporting the product through… more
- Genmab (NJ)
- …setting.The Director, HEOL Team Lead is part of the US Field Medical Affairs leadership team responsible for the execution of the US Medical Affairs strategy ... insights and needs for materials related to field engagementCooperate with Field Medical Affairs leadership team to co- lead and manage change initiatives in the… more
- USAA (San Antonio, TX)
- …community and their families-making every interaction more meaningful. As a dedicated Corporate Affairs Business Partner at the Lead level, you will serve as ... and strategic talent to help shape it. USAA's Corporate Affairs team is growing as part of an exciting...measured, monitored, and controlled in accordance with risk and compliance policies and procedures. What you have: Bachelor's Degree… more
- USAA (San Antonio, TX)
- …looking for bold, creative, and strategic talent to help shape it. USAA's Corporate Affairs team is growing as part of an exciting transformation to strengthen how ... more meaningful. As a strategic Account Manager supporting USAA - you'll lead the development and delivery of integrated communications strategies that inform,… more
- Eisai, Inc (Fort Worth, TX)
- …to work independently and not require close supervision while adhering to compliance / regulatory policies. Interest in leading and participating in projects while ... Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the...congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL… more
- Insmed Incorporated (NJ)
- … regulatory and internal quality standards.Work closely with Quality Assurance, Regulatory Affairs , Manufacturing, and Analytical team to support timely ... such as Deviations, Change Controls and CAPAs.Work closely with Quality Assurance, Regulatory Affairs , Manufacturing, and Analytical teams to support timely… more
- Eisai, Inc (Chicago, IL)
- …implement recommendations for resolution.Certification is a plus (such as Regulatory Affairs Professional Society (RAPS)Technical Skills RequiredAdvance working ... and overseeing the planning, preparation, coordination, and delivery of global regulatory submissions in compliance with applicable regulations and standards.… more
- Merck & Co. (Rahway, NJ)
- …Biology, Process Analytical Technology (PAT), Professional Networking, Quality Control Management, Regulatory Affairs Compliance , Regulatory ... affairs , to ensure comprehensive biophysical characterization of products.Ensure compliance with regulatory guidelines and industry standards related to… more
- Insmed Incorporated (NJ)
- …represent content during medical, legal, and regulatory review.With Medical Excellence, lead training of Medical Affairs teams on new materials and upcoming ... Reporting to the Head of Scientific Communications & Publications, you'll lead the development and implementation of global Medical Communications Strategy across… more
- Merck & Co. (Rahway, NJ)
- …acumen and expertise in data and data standards across Clinical Development, Medical Affairs , and Regulatory Affairs domains. Apply domain knowledge to ... accessibility across the complex clinical development ecosystem. Reporting to the BIA team lead , the Senior Specialist / Information Architect will play a key role… more
- Insmed Incorporated (NJ)
- …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 ... review and approval process. You will ensure efficient coordination of MRC activities, compliance with company policies and regulatory standards, and the quality… more
- Eisai, Inc (Nutley, NJ)
- …matters involving privacy.Benefits (20%) Counsel and support the HR team on HIPAA compliance and broader regulatory obligations (including ERISA, COBRA, and ACA) ... a strategic, business-minded, and hands-on attorney role whose job will be to lead Eisai's privacy initiatives across the US and Canada and partner with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … affairs , market access and policy/advocacy (MAPA), Global Commercial, regulatory affairs , other relevant NNI departments. Essential Functions Identify, ... actionable marketing strategies to guide customer experiences Strong understanding of regulatory , compliance , and ethical considerations in engaging with… more
- Merck & Co. (South San Francisco, CA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Merck & Co. (Rahway, NJ)
- …marketing teams within the organization along with sales, product development, regulatory affairs , customer service, and other cross-functional teams to ... experience-driven omnichannel engine across our US Animal Health portfolio. You will lead a team that owns digital demand creation and customer experience for… more
- Merck & Co. (North Wales, PA)
- …the US improve patient experience, treatment adherence, and outcomes while maintaining compliance with the highest ethical and regulatory standards.- The ... IBD patients in support of the launch of our lead asset in immunology. This role will develop a...with global and ex-U.S. commercial, medical, access, policy, and compliance stakeholders to ensure that Therapy Patient Programs (TPPs)… more
- Syner-G BioPharma Group (Boston, MA)
- …systems, and energy management.Collaborate with internal stakeholders including EHS, IT, and Regulatory Affairs to support compliance and operational ... and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance , empowering our clients to navigate complexity and… more
- Insmed Incorporated (NJ)
- …will be vital as you partner with Discovery, Clinical Development, Quality, Regulatory Affairs , Operations, and Commercial teams to ensure seamless program ... with serious diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and Controls (CMC) activities for the company's small… more
- AUROBINDO (Durham, NC)
- …with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs . In addition to several formulations under manufacture, we ... and laboratory GLP/cGMP/GxP complianceEnsuring the accuracy of analytical measurements and compliance with cGMP, US FDA, and other regulatory and corporate… more
