- 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 directing ... globally, coordinating departmental and cross-functional support.Responsibilities Designs and implements regulatory strategies to obtain, maintain product investigative… more
- Repligen (Waltham, MA)
- …and driven IT Business Partner to represent our Manufacturing, Quality, Supply Chain, Product Development, and R&D organizations. As a Director of IT, you ... efficiency, and enabling innovation across the bioprocessing manufacturing and product development lifecycle.This position requires strong collaboration with business… more
- Insmed Incorporated (NJ)
- …risk minimization and pharmacovigilance measures in compliance with regulatory requirements. Develop/provide input to product Benefit-Risk Assessments, ... company and regulatory policies and procedures. In addition, the Senior Director will be responsible, globally, for implementing the safety and risk management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for the integrity, transparency, and governance of global forecasts, ensuring compliance with internal policies and external regulatory requirements.Lead audit ... research areas centered around rare diseases and immune disorders. Job Summary Director , Global Oncology Forecasting will be responsible for leading and owning… more
- Eisai, Inc (Bethesda, OH)
- …Engineering functions for artwork control and approval.Ensure consistency of labeling across product lines and compliance with Eisai policies and procedures and ... your profile, we want to hear from you. The Director , Global Labeling is responsible for the leadership and...and requirementsSolid knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ultimately negotiated with assigned accounts. Relationships Reports to the Executive Director / Director on the Strategic Pricing and Contracting team. Works ... Rare Disease), as well as with internal stakeholders (Government Contracts & Compliance , Rebate Operations and Insights, Market Access Strategy, Legal, and others).… more
- Merck & Co. (Rahway, NJ)
- …within the Device Development team and with external partners.Understand and apply regulatory and compliance requirements relevant to device risk management ... team, responsible for spearheading risk management efforts in combination product development, commercialization, and lifecycle management. This individual will… more
- Merck & Co. (Rahway, NJ)
- …biologics, and vaccines. Be part of a dedicated team that thrives on compliance and robustness, driving excellence in logistics technology and making a meaningful ... other functions at our companyDevelop regional strategies for temperature-controlled product movement in collaboration with stakeholders.Create detailed specifications for… more
- Formation Bio (New York, NY)
- … vendors, for both development and manufacturing, ensuring high-quality deliverables and compliance with GMP and regulatory standards. Documentation: Author and ... review technical documents in collaboration with Quality colleagues to assure compliance with current GxP regulations. Regulatory submissions: Author, and… more
- Insmed Incorporated (NJ)
- …Marketing Cloud initiatives with commercial strategy, data governance, and compliance policies (including privacy, consent, and regulatory requirements).Provide ... of science, we're in. Are you?About the Role:We're looking for an Associate Director , IT Marketing Technologies, on the Information Technology team to help us expand… more
- Eisai, Inc (Dallas, TX)
- …If this is your profile, we want to hear from you. The Associate Director , Access and Reimbursement (AD ARM) will lead the Eisai Access and Reimbursement Managers ... Access and Reimbursement Services, Sales, Marketing, Government Affairs, Legal, Compliance , Medical, and Training. Ultimately, this individual will be responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audit activities which includes mock pre-approval inspections, routine ongoing GMP compliance audits and GMP regulatory inspections. Support the establishment, ... Ensure inspection readiness are adequately performed and may support and/or lead regulatory inspection activities at DS facilities and / or CMOs. The incumbent… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in… 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 ... of science, we're in. Are you?About the Role:The Medical Director , Medical Affairs - Dermatology role will be responsible...- Dermatology role will be responsible for supporting the product through its life cycle for hidradenitis suppurativa (HS)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , Engineering as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe Associate Director of Engineering is a strategic and operational leader responsible for the management, development, and performance of… more
- Merck & Co. (Rahway, NJ)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication.Specifically, The Clinical Director May Be ... and manufacturing to manage clinical development projectsAssist the Senior Director , Associate Vice-President/Vice-President and Product Development Team Lead… more
- Novo Nordisk Inc. (Seattle, WA)
- …SOPs and working practices Complies with all guidelines, policies, legal, regulatory , and compliance requirements Ensures effective administrative management of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (New Orleans, LA)
- …SOPs and working practices Complies with all guidelines, policies, legal, regulatory , and compliance requirements Ensures effective administrative management of ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...education and collecting data to support efficacy and new product development, CMR is involved. The one thing that… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …team, Commercial Operations, Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory , Quality, Legal, Privacy and Finance. External ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one... with Novo Nordisk and FDA requirements Responsible for Product Safety compliance across all Patient Support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …review, update, validate, and version-control business rules to ensure accuracy, compliance , and alignment with evolving strategy and regulatory requirements ... Team leads the US sales efforts for Novo Nordisk's robust cardiometabolic product portfolio, which includes world class therapies for the treatment of diabetes,… more
