- 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
- 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
- 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
- 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
- Eisai, Inc (Philadelphia, PA)
- …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
- Merck & Co. (North Wales, PA)
- Job DescriptionAssociate Director US Marketing, HCP Strategy - OphthalmologyOur company is dedicated to delivering innovations that extend and improve the lives of ... (nAMD), and retinal vein occlusion (RVO)).-We are currently recruiting for an Associate Director US Marketing, HCP Strategy - Ophthalmology. This is an exciting time… more
- Merck & Co. (Rahway, NJ)
- …the respective marketing teams within the organization along with sales, product development, regulatory affairs, customer service, and other cross-functional ... livestock (beef, dairy, swine, poultry, aquaculture). Reporting to the Executive Director , Channel Operations & Engagement, you will connect brand teams,… 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
- 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)
- …and drug product container closure systems including mold qualification and regulatory compliance .- To act as master data stewards and support enterprise ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across… more
- Eisai, Inc (Bethesda, OH)
- …methodology to conduct studies relating to the life cycle of the product . In development-phase projects, prepares the statistical component of protocols which meet ... specifications and directions to the clinicians/statistical programmers. Supports the regulatory review and approval of the experimental therapies. May partner… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development (DPPD) ... years of leadership experience with deep working knowledge of device, biologic/drug product , and process development including regulatory submission and approval… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.-The Packaging Technical Operations organization aims to… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director ... for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.- The Packaging Technical Operations organization aims… more
- Genmab (NJ)
- …and adherence to corporate complianceCurrent working knowledge of US-specific legal, regulatory , and compliance regulations and guidelines relevant to industry ... fit? Then we would love to have you join us!The RoleGenmab is currently seeking a Director , HEOL (Health Evidence and Outcomes Liaison) Team Lead to be a part of an… more
