- Novo Nordisk Inc. (Plainsboro, NJ)
- …ready to make a difference? The Position We are seeking a dynamic and experienced Regulatory Affairs Labeling Associate Manager to oversee and lead critical ... having a wide range of experience and a complete understanding of Regulatory Labeling roles and responsibilities Demonstrates full knowledge of industry… more
- 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
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director, Global Regulatory Affairs, Regulatory Strategy to be ... regulatory success. Represent US RA in the Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional… 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 (Cherry Hill, NJ)
- …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
- Bristol Myers Squibb (Princeton, NJ)
- …FDA guidelines. The role works closely with the Proofreading team, Labeling Operations, Commercial Regulatory Affairs, and Worldwide Commercialization Excellence ... responsible for the seamless implementation of prescribing information and all derivative labeling documents across all brands. This is an important role within US… more
- Bristol Myers Squibb (Princeton, NJ)
- …Channel Operations is responsible for managing the operational processes associated with product labeling updates in the US market. This role will define, drive, and ... brands. The role works closely with the Brand Teams, Commercial Regulatory Affairs, Worldwide Commercialization Excellence (WCE) and the cross-functional teams on… 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
- 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
- Fresenius Medical Center (Cherry Hill, NJ)
- …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
- 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
