- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be ... of labeling documents according to internal SOPs and external regulatory requirements.Prepares submission-ready labeling documents; Maintains and tracks … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director, Regulatory Affairs - Advertising & Promotion will provide strategic ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...promoting potential data/claims with manager oversight Participate/assist in US labeling negotiations as necessary. Ensure that changes in US… more
- Integra LifeSciences (Princeton, NJ)
- … regulatory compliance, and cost management/process efficiency objectives. The Labeling Associate will collaborate with cross-functional teams, including ... patient outcomes and set new standards of care. The Labeling Associate will assist with the execution...ensuring compliance with both internal corporate standards and external regulatory requirements. This role will be assisting the strategic… more
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. The Labeling Associate - Design is responsible for creating, reviewing, approving, and ... members for and project teams on all project execution + Assist the Senior Labeling Associate in integrating and implementing Integra's electronic labeling … more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for ... of labeling documentation and assures that Takeda labeling content and processes conform to regulatory ...Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions… more
- Bristol Myers Squibb (Princeton, NJ)
- …. **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... pharmaceutical products across therapeutic areas + Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global… more
- IQVIA (King Of Prussia, PA)
- …particular. Experience in developing evidence dossiers and briefing books to support product labeling based on PRO and other COA endpoints consistent with the Food ... processes for COA Consulting services; training and mentoring Associates, Associate Consultants, Consultants, and Managers in these Project Management processes… more
- Merck (West Point, PA)
- …clinical trials. Global Clinical Supply is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. ... Global Clinical Supply Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,… more
- Endo International (Horsham, PA)
- …systems, such as facility/equipment, utilities, materials, production, laboratory, packaging/ labeling , and general compliance as applicable. Assures compliance with ... current domestic and international GMPs and regulatory agencies. This role contributes to and may lead...activities and special projects. **Qualifications** Education & Experience + Associate 's degree in science or engineering with 7+ years'… more
- Merck (West Point, PA)
- **Job Description** The Associate Vice President (AVP) is responsible for providing leadership for the Global Clinical Supply (GCS) group within Pharmaceutical ... Sciences & Clinical Supply (PSCS) which encompasses planning, packaging, labeling and distribution of clinical supplies with associated support functionality. The… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to ... over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel,… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to ... depending upon your project needs. Using our Clinicopia global labeling system with its multi-lingual label phrase library we...and assessments of problems or potential problems to the Associate Director, QMS + Lead the implementation of new… more
- Fresenius Medical Center (Philadelphia, PA)
- …philosophy. Adheres to the Organization's Compliance Program, including following all regulatory and policy requirements. Assists physicians in performing a variety ... + Draws up intravenous medication and labels as per the organization's medication labeling policy. + Processes x-ray images and archives to the image repository, CD… more
- Integra LifeSciences (Plainsboro, NJ)
- …in ensuring that products meet the required safety, performance, and regulatory standards before they reach the market. Their responsibilities typically include: ... visual, mechanical, and sometimes functional tests to ensure products meet regulatory requirements (such as FDA or ISO standards). Documentation and Reporting:… more
- Fujifilm (Trenton, NJ)
- …leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more ... factors, which may include customer impact, HCUS business priorities, and regulatory requirements. Normally receives little instruction on day-to-day work and… more
- Merck (West Point, PA)
- …+ Dispose of Process waste material as per departmental SOP and regulatory guidelines. **Equipment (including but not limited to):** + ANALYTICAL EQUIPMENT (eg ... EQUIPMENT (eg autoclaves and tanks) + IDENTIFICATION SYSTEMS (eg labeling devices) + MAINTENANCE EQUIPMENT (eg tools and calibration...database system. + Performs all job functions of Support Associate or Clerk as required. + Delivers all samples… more
- Fujifilm (Trenton, NJ)
- …leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more ... all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable… more
- Fujifilm (Trenton, NJ)
- …leading laboratories across the country and diagnostic chemicals for OEM white labeling products. The company is headquartered in Lexington, Massachusetts. For more ... all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements, and all other applicable… more
