- Merck & Co. (Rahway, NJ)
- …with stakeholders in partner organization and to management and governance teams.Support regulatory filing by authoring and reviewing regulatory submissions and ... data in context of broader process and product development.-Working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing … more
- Insmed Incorporated (San Diego, CA)
- …management and remain in a validated state per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of validated ... responsibility for computer systems specifically LIMS, eTMF/CTMS, and other Clinical /Manufacturing systems.2+ years' in a managerial role with people/project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …globally, and provide legal support for licensing, co-promotion, co-development, clinical trial collaboration, co-marketing and acquisition agreements (among other ... in negotiating, drafting and reviewing licensing, co-promotion, co-development, co-marketing, clinical trial collaboration, companion diagnostic, and acquisition agreements.- Conducts… more
- Insmed Incorporated (NJ)
- …role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director, ... ensuring alignment with the company's values, business priorities, and regulatory commitments.Present cybersecurity posture, emerging threats, and key initiatives to… more
- Eisai, Inc (Miami, FL)
- …international regulatory /ethical guidelines relevant to the pharmaceutical industry & clinical trial conduct, and to ensure compliance with these external as ... with strategic and tactical planning, working collaboratively with Medical Affairs and Clinical Development teams for support of clinical studies across the… more
- Eisai, Inc (Nutley, NJ)
- …the goal to contribute to the development and the communication of clinical , real-world, health economics outcomes data. This role primarily focuses on late-stage ... economic and product value data.Engage healthcare and access stakeholders in clinical , scientific, and health economic exchange.Formulate HEOR and RWE strategies… more
- Insmed Incorporated (NJ)
- …a validated state (eg SDLC, IT Change Control) per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of validated ... systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other Clinical /Manufacturing systems.Project lead experience preferred.Strong experience in Clinical … more
- Eisai, Inc (Sarasota, FL)
- …will have the primary role of demand generation by conveying complex clinical information to customers and key stakeholders consistent with the FDA-approved ... demand generation within assigned geography by effectively conveying complex clinical information to customers and key stakeholders.Develop, maintain, and execute… more
- Insmed Incorporated (NJ)
- …from concept to implementation, ensuring that our packaging meets all regulatory requirements, protects product integrity, and enhances user experience. The ... individual will conduct packaging development projects from initiation through clinical and commercial manufacture (launch & beyond). Projects will consist of… more
- Eisai, Inc (Cincinnati, OH)
- …customer business, disease state, product prescribing information, approved promotional clinical trials, patient access to medication, and regulatory /compliance ... decision-makers through understanding of issues and opportunities in territory. Deliver clinical , efficacy, and safety messaging and information about product access… more
