- Merck & Co. (Rahway, NJ)
- …development skillsets.Demonstrated strength in delivering results on firm deadlines in support of product discovery, process development and commercial filings ... Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to… more
- Merck & Co. (Rahway, NJ)
- …regulatory compliance, aligning with the company's divisional and local site procedures. Support regulatory inspections and maintain proficiency in ISO 13485, ... receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of...through the development team and governance forumsAuthor and complete regulatory filing sections, and support response to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs the Product Security Lead Designer, you will play a pivotal role in shaping the security landscape of our organization. Your primary ... DevSecOps, ), ensuring alignment with industry best practices and regulatory requirements.Collaborating with Cross-Functional Teams: Work closely with engineering, … more
- Merck & Co. (Rahway, NJ)
- …(GBO) organization is responsible for manufacturing and supplying commercial biologic products that support over $30 billion in annual sales. GBO is now preparing to ... sites-Dunboyne, Dublin, Carlow, and Wilmington-to successfully execute multiple New Product Introductions (NPIs), Process Performance Qualifications (PPQs), Pre-Approval Inspections… more
- Merck & Co. (Durham, NC)
- …deepening process understanding Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments ... vaccine capital projects Provide deep SME knowledge for manufacturing investigations support ( Product and process deviations and complex material-related)… more
- Merck & Co. (Rahway, NJ)
- …ogram (s) . The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (ie clinical ... balancing needs of patients & ensuring stable supply of product . - -- Primary activities include, but are not...GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs.Facilitate operational meetings with CROs, License Partners, ... submission to Health Authorities and License Partners, Reconciliation with License Partners, Patient Support Programs, Market Research vendors, Global… more
- Merck & Co. (Rahway, NJ)
- …global standards and procedures related to biologics, vaccines, and finished product ensuring compliance with regulatory requirementsActively participate in ... biologics, vaccine drug substances and finished products. As Director, you will support Quality audits and health authority inspections and ensure any resulting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …up-to-date information on the therapeutic area and NNI clinical plans and study results, product support letters, and the Marketing and Sales product plan ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (Durham, NC)
- …and collaboration skills responsible for supporting Operational Readiness projects to support biological processes for a new manufacturing facility or currently ... role will contribute to the performance and results of a E2E drug substance/ product department and provide technical guidance. Off-shift and weekend coverage will be… more
- Merck & Co. (Rahway, NJ)
- …development related meetings (i .e., Clinical Trial Team s ) and product development related meetings . The incumbent must have demonstrated understanding of ... E2E product development process & connectivity between functions supporting pipeline...Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address… more
- Merck & Co. (Rahway, NJ)
- …change management, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will ... Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing… more
- Merck & Co. (Durham, NC)
- …resources activities while ensuring a safe work environment with optimized product quality and manufacturing processes and regulatory compliance.GENERAL ... activities related to the facility.Strong technical and customer service-oriented leader to support the GBF IPT. Will lead the tactical and strategic equipment… more
- Merck & Co. (North Wales, PA)
- …the following responsibilities:1.) development of the integrated evidence strategy to support HTA/ reimbursement/ NITAG evaluations; 2.) development of overall Real ... to obtain in-depth understanding of country specific HTA/reimbursement needs for the product and gain input on research design and implementation of retrospective… more
- Merck & Co. (Rahway, NJ)
- …and retaining diverse talent.Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and ... Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our… more
- Merck & Co. (Rahway, NJ)
- …Marketing, Member Services, and Finance to deliver cohesive and member-centric payment experiences. Support new product launches and core system initiatives from ... Sponsorship:No Travel Requirements: 10%Flexible Work Arrangements:Not ApplicableShift:Not IndicatedValid Driving License :NoHazardous Material(s):N/ARequired Skills:Accounting Reconciliation, Account Management, Administrative Support… more
- Merck & Co. (Durham, NC)
- …drug product , including biotech culture growth, harvest, lyophilization, product inspection, utilities, and warehouse.The candidate will support the ... Lead Tech, Engineering is a member of the Engineering team providing technical support within a capital project start-up in Durham, North Carolina. The new facility… more
- Merck & Co. (North Wales, PA)
- …Integration, Operational Excellence, Oral Communications, Pharmaceutical Management, Product Registrations, Professional Networking, Project Management, ... including pipeline candidates and licensed products. The Section Head manages Product Development Team (PDT) leaders and clinical directors responsible for the… more
- Merck & Co. (North Wales, PA)
- …to collaborate with many teams and competing priorities.-Primary Responsibilities:Provide ongoing support to job owners and agency partners on promotional review ... review and label update processes and collaborate with the Medical Legal Regulatory Review teams to find solutions and make improvementsDevelop/enhance resources and… more
- Merck & Co. (Rahway, NJ)
- …seeking an experienced leader who will manage a team of scientists to support drug substance process development activities to enable and accelerate early and ... upstream and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial… more
