- 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
- Merck & Co. (Rahway, NJ)
- …Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The main focus will be on document production ... include:Function as Business System Owner (BSO) of the current Documentum-based global submission content management solutionCo-lead the implementation of the next… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership role within the Device Development and Technology Organization. This ... with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The associate director will be a technical subject matter expert on the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role within the Device Development and Technology Organization. Thisposition is ... with a focus on autoinjectors, prefilled syringes, and other drug deliverysystems. The Associate Director will collaborate with a team of engineers and technical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe USDA Compliance Subject Matter Expert (SME) - Associate Director , will report to the Animal Health Global Quality Compliance and Technical ... Compliance (IC), and Policy, Licensing and Evaluation (PEL).Develop and maintain global Quality Management System (QMS) documents pertaining to USDA requirements for… more
- Merck & Co. (Rahway, NJ)
- …real estate solutions to meet the needs of our Company's global businesses units, including those in Manufacturing, Commercial, Technical Operations, Research ... Have you advised on design standards, project scope, and regulatory compliance as well as act as a liaison...external consultants to gather input and facilitate planning initiatives?Our Global Real Estate Workplace Strategy team is seeking an… 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across our company ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies and… 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. (Rahway, NJ)
- …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
- 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 ... centered around rare diseases and immune disorders. Summary: Oversees Local/ Global Pharmacovigilance (PV) service providers responsible for Call Center, individual… 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
- Merck & Co. (Rahway, NJ)
- …internationally and are grouped into center-led categories and regional operating teams.The Associate Director of Global Operations Sourcing has direct ... Process to manage assurance of supply, quality, service, cost, innovation and regulatory compliance within Global or International category of spend, resulting… more
- Organon & Co. (Jersey City, NJ)
- …INDs, briefing books and other regulatory documents, as applicable. The Associate Director , Biopharmaceutics will be the primary author for module 2.7.1 ... **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert...for global regulatory submissions. **Responsibilities** + Provide support… more
- Organon & Co. (Jersey City, NJ)
- …IND, NDA), briefing books, or other regulatory communications for regional regulatory submissions or renewals for global products within the Organon ... cross-functional development programs with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls… more
- Organon & Co. (Jersey City, NJ)
- …Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal Scientist is ... strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation… more
- Organon & Co. (Jersey City, NJ)
- …**The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate Principal Scientist is responsible for?developing and?implementing ... Controls (CMC) strategies for?assigned?small molecule products in accordance with global regulations and?guidance, and?Organon procedures.? The Associate … 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
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The role of Associate Director , Dermatology Outcomes Research Epidemiology and Economics will report to the headquarters ... Director of Medical Affairs Outcomes Research. Focusing on Dermatology,...priorities. Developing and implementing patient-centred endpoints strategies, working with regulatory , Value Strategy Assessment (VSA's) and contracting. The role… more
- SMBC (Jersey City, NJ)
- …objectives, and monitoring and evaluating work. This position works closely with Director of Regulatory Reporting Change Management Department to ensure proper ... SMBC Group is a top-tier global financial group. Headquartered in Tokyo and with...This position is a subject matter expert in the Regulatory Reporting Automation for BHC, Branch, Liquidity or Broker… more
