- ValSource, Inc. (Rahway, NJ)
- …the FDA regulated pharmaceutical and biotech manufacturing industries. Project Manager is responsible for managing and executing validation projects directly at ... Project Manager ValSource is currently looking to identify experienced...validation and equipment qualification activities, and ensuring compliance with FDA , GMP, and other regulatory requirements. ResponsibilitiesOn-Site Project Management:… more
- Eckert & Ziegler Isotope Products, Inc. (Valencia, CA)
- Quality Assurance & Regulatory Manager Valencia & Burbank, CA Company Benefits 100% employer paid medical and dental 401(k) matching contribution Generous PTO and ... The Job Eckert & Ziegler Isotope Products seeks a Quality Assurance & Regulatory Manager to join our team. The Quality Assurance and Regulatory Manager supports… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... complex after hours inquiries from healthcare professionals Ensures compliance with FDA requirements as they affect Medical Communications; responses must be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... to Novo Nordisk products and in compliance with Novo Nordisk and FDA requirements Responsible for Product Safety compliance across all Patient Support Programs… more
- Insmed Incorporated (San Diego, CA)
- …understanding of document management principles.Solid working knowledge of CSV guidelines and FDA /EU regulations:21 CFR Part 11, Annex 11, GAMP 5, Good Clinical ... Practices, GMPs, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing skills for authoring, reviewing… more
- Insmed Incorporated (NJ)
- …is preferred.Experience with Veeva QualityDocs /QMSSolid working knowledge of CSV guidelines and FDA /EU regulations: 21 CFR Part 11, Annex 11, GAMP 5, Good Clinical ... Practices, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing skills for authoring, reviewing and… more
- Lundbeck (Atlanta, GA)
- …to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Aptyx (Charlotte, NC)
- Project Manager (PM) is responsible for planning, overseeing, and leading projects from ideation through completion. This role requires interaction with a range of ... experience is highly preferred to plan and conduct complex development projects within FDA and ISO regulatory requirements. Education BS or MS in Engineering is… more
- Lundbeck (Norristown, PA)
- …transform lives. Join us on our journey of growth! As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Daiichi Sankyo, Inc. (Chicago, IL)
- …areas centered around rare diseases and immune disorders. Summary:The District Manager (DM) represents Daiichi-Sankyo to assigned customers. The DM hires, leads, ... Director, oversee the promotion of the assigned products consistent with the FDA label to assigned customers, using approved messages and resources. Build, lead,… more
- Lundbeck (Phoenix, AZ)
- …lives. Join us on our journey of growth! As a Neuroscience Account Manager , you lead the promotion of our psychiatry portfolio to Psychiatrist and Institutional ... including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The RoleThe Senior Manager , Clinical Programming is responsible for the establishment, governance, and integrity of Study ... knowledge of clinical research, metadata management, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements Demonstrated experience… more
- Cipla (Hauppauge, NY)
- …Ensure that the artwork complies with all relevant regulatory guidelines (eg, FDA , EMA) and industry standards, including proper labeling, dosage information, and ... maintained in state of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during… more
- Formation Bio (New York, NY)
- …and resource allocation. Ensure all clinical trials comply with ICH-GCP, FDA regulations, and other applicable regulatory standards. Champion proactive risk ... clinical assets and associated studies. Step in as the Clinical Project Manager when needs arise. Operational Strategy and Leadership Develop and implement… more
- Cipla (Fall River, MA)
- …- 5:00 PM (may vary based on business needs) Reports To : Packaging Manager Pay Range: $78,000 - $99,840 Purpose: InvaGen Pharmaceuticals, Inc. is searching for ... ensures compliance with cGMP's, InvaGen Pharmaceutical's policies,standard operating procedures, and FDA requirements. The incumbent will serve as a key resource… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... encore abstracts, reviews, and supplements) in collaboration with Publications Manager Independent Medical Education (IME) Assist in developing medical education… more
- Cipla (Central Islip, NY)
- …5:00PM (may vary based on business needs) Reports To: Quality Assurance Manager Purpose: This position requires a strong analytical chemistry/lab background and ... other departmental and cross-functional projects and assignments given by the manager /supervisor. Education and Experience Possess a minimum bachelor's degree in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …records, forms, and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel, provide input on ... shift (1st or 2nd shift) is required.Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell-based products, and cleanroom behaviors.Must… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …of GMP pharmaceutical manufacturing equipment in line with Novo Nordisk and FDA requirements. They are responsible for the development of cleaning processes, the ... perfume/cologne, and personal cell phones. Relationships Reports to: Associate Manager Essential Functions Assist with SOPs, JIs, Deviations,cand other production… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …at our bioproduction facility in West Lebanon, NH. Relationships Reports to: Manager , Process Support (Downstream) Essential Functions Assist with SOPs, JIs, DVs and ... processes are verified and are kept in a validated state in accordance with FDA , EU and NN requirements Actively participate in cross functional teams to determine… more
