- Repligen (Waltham, MA)
- …global public company is seeking a strong, experienced, and technically sound Senior Director , Assistant Corporate Controller who will oversee the Company's ... OverviewMake a global impact-join Repligen.We're united by a mission to...accordance with GAAP.Ensure timely and accurate financial reporting to senior management and external stakeholders, including quarterly and annual… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionThe Sr . Specialist of Biosafety is accountable for providing and managing an efficient and effective Biosafety program at the Millsboro, Delaware ... working environment in compliance with local, state, and federal regulations. The Sr . Specalist of Biosafety will collaborate with various departments to promote… more
- Merck & Co. (Rahway, NJ)
- …Team.-This Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global Regulatory Affairs & ... how we operationalize CMC. This individual will be a senior member of the Regulatory Affairs CMC...CMC post-approval-changes.Leverage industry and agency connections in partnership with Regulatory Affairs Global Regulatory Policy… more
- Merck & Co. (Upper Gwynedd, PA)
- …analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior Director may be responsible for: -Analyzing and summarizing ... Job DescriptionOur company is a global health care leader with a diversified portfolio...radically changes the way we approach serious diseases. --The Senior Director will report to an Associate… 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. (Rahway, NJ)
- Job DescriptionThe Senior Director of Human Factors (HF) will provide visionary leadership and strategic direction for the HF function within our company. This ... principles to enhance patient safety and product usability. The Senior Director will champion enterprise-wide HF strategy,...growing HF teams in a regulated environment.Deep knowledge of global HF regulatory requirements, FDA guidance, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Sr . Director , Clinical Safety MD, will lead the development and ... Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all Medical Affairs programs. This role involves deputizing for the Sr . Director , representing the Quality organization at senior levels. The Director ... studies, non-interventional studies, Compassionate Use or Managed Access Programs.Collaborate with the Sr Director , Medical Affairs QA to conduct quality reviews… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality ... operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for audits,… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs ... VP of Regulatory Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs, Medical Analytics will be responsible ... 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
- Eisai, Inc (Nutley, NJ)
- …mgmt. activities. #LI-CCEisai Salary Transparency Language:The base salary range for the Senior Director , Clinical Quality Assurance - Remote-Based is from ... (QAP) position is responsible for design, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management,… more
- Capital One Bank (Newport News, VA)
- Director , Payment Network Technology RiskCapital One is one of the fastest growing organizations in the world today, powered by our passion for our customers. We are ... ability to add value with their advice and to deliver high-impact results. Director , Payment Network Technology RiskWe are actively seeking a highly technical and… 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 ... so, he or she will align closely with the Global Project Team and Global Team Leader...plans, clinical protocols, and in the submission of certain regulatory documents, as well as supporting commercial in developing… more
- Merck & Co. (Rahway, NJ)
- …with senior level stakeholders for Small Molecule products across Global Pharmaceutical Operations (GPO) and the Manufacturing Organization.- As the VCMT leader, ... company's Manufacturing Division product supply chain strategy in alignment with Global Human Health brand/franchise commercial goals. The Small Molecule VCM Product… more
- Eisai, Inc (Nutley, NJ)
- …new system implementations, including vendor selection and onboarding Present updates to senior leadership on compliance trends, regulatory changes, and program ... profile, we want to hear from you. The Associate Director , Compliance Operations will be a key member of...systems and processes to support departmental and organizational needs. Global experience is preferred, as Eisai continues to expand… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , Engineering, Packaging Commercialization will lead packaging development for new products including parenteral products ... new products on cross-functional teams. - - The Associate Director will be accountable for the d efinition and...execution of overall packaging strate g ies that meet global network needs. Responsibilities include ensuring packaging system design… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise ... Legend Biotech is a global biotechnology company dedicated to treating, and one...production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring,… more
- Cytek Biosciences, Inc. (San Diego, CA)
- SUMMARY: The Director / Sr . Director , Reagent Operations will lead and manage reagent manufacturing operations, worldwide distribution and positioning of ... market demand; transforming reagent operations to support min 50%+ increase in global segment annual revenues. ESSENTIAL DUTIES AND RESPONSIBILITIES : To perform… more
- Merck & Co. (Rahway, NJ)
- …to the Director of Capital Procurement Project Execution within the Global Capital Procurement organization, the Associate Director will serve as the ... Job Description Role Summary The Associate Director of Procurement for Capital Projects will be...Procurement Planning Use your capital procurement expertise to influence global project teams and senior management in… more
