- Merck & Co. (Millsboro, DE)
- …operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for audits, ... Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs, EHS, Engineering, BTS, ATS and HR.Direct technical… more
- Merck & Co. (North Wales, PA)
- …Process Owner for one or more of the QMS processes managed under GRACS( Global Regulatory Affairs & Clinical Safety) Quality &Compliance.Establishes and maintains ... Research & Development Division and Enterprise levels. The position supervises two Associate Directors.Primary activities include but are not limited to: Serve as … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs, Medical Analytics ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Durham, NC)
- …Description Position Description: Under the direction of the Network Strategy & Execution Director , the Associate Director is responsible for assessing, ... ensure delivery of the targeted goals and timelines. The Associate Director will effectively and efficiently achieve... Regulatory Acumen and effective working relationship with Global Regulatory Affairs and Clinical Safety (GRACS)… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products ... erience developing and commercializing new products on cross-functional teams. - - The Associate Director will be accountable for the d efinition and execution… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. The Associate Director , Compliance Operations will be a key member of Eisai's US Ethics & ... US monitoring activities, managing in-house efforts and third-party vendor engagements. The Associate Director will also play a critical role in advancing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and… more
- Merck & Co. (Upper Gwynedd, PA)
- …science that radically changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in the Oncology ... Job DescriptionOur company is a global health care leader with a diversified portfolio...Group. Under the guidance of a supervisor, the Senior Director has primary responsibility for the planning and directing… more
- Merck & Co. (Rahway, NJ)
- …Quality Assurance oversight for computer system validation matters within the Global Development Quality organization and for the Company's Research & Development ... respect to the Quality Management System and Compliance pillars of Global Development Quality for the purposes of investigations, corrective action/preventive… more
- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director , EDC Programming will lead and oversee EDC ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most… more
- Merck & Co. (Rahway, NJ)
- …execution, along with leadership skills to shape the technical capabilities lead a global , cross-modality technical team.The Associate Director will lead a ... into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be responsible… more
- Genmab (NJ)
- …and feel like a fit? Then we would love to have you join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of ... as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring, development, ... Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise… more
- Merck & Co. (Rahway, NJ)
- …Procurement Project Execution within the Global Capital Procurement organization, the Associate Director will serve as the primary point of contact for ... Job Description Role Summary The Associate Director of Procurement for Capital...functions in their assigned area. They will collaborate with Global Capital category teams and cross-functional teams across the… more
- Merck & Co. (Rahway, NJ)
- …DescriptionReporting into the Director Packaging Platform Technical Leadership the Associate Director Medical Device and Combination Product (MDCP) Platform ... of commercialized products for the benefit of patients. The Associate Director of MDCP Platform Packaging and...generate gap analysis and mitigation strategies In-depth knowledge of global regulatory requirements for medical devices and… more
- Merck & Co. (Millsboro, DE)
- … Global Safety & Environment organization, and reports to the Associate Director of Safety & Environment at Millsboro, DE.Responsibilities:Ensure compliance ... records of incidents and ensure proper reporting to relevant regulatory authorities as required.Conduct regular inspections of laboratories and facilities… more
- JobElephant (Washington, DC)
- …expectations and outcomes.Work InteractionsThis position reports directly to the Associate Director , Energy and Sustainability Programs. Provides project ... and US Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, DC Our… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director , Global Regulatory Lead (GRL), reporting to the Executive Director , Senior Director ... projects in their assigned therapeutic area portfolio. **Responsibilities** The Associate Director will be responsible to: + Develop regulatory strategy for… more