- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides ... strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of… 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
- Merck & Co. (Rahway, NJ)
- …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
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides ... strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an ad hoc member of… 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
- Colgate-Palmolive (Piscataway, NJ)
- …goals. Together, let's build a brighter, healthier future for all. **Scope:** The Regulatory Affairs Associate Manager supports Colgate's Oral Care and Personal ... Care divisions. This position involves engaging in regulatory activities necessary for the maintenance of existing products as well as the development and… 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
- Colonial Pipeline Company (Avenel, NJ)
- …refined products to more than 50 million Americans. **About the Field Operator ( Associate , I, II) Position** The Field Operator position may be filled at the ... Associate Level, Level I, or Level II depending on...assets. + Field Operators II independently perform daily inventories, regulatory checklists, inspections, pig launches and receipt, inventory, minor… more
- IQVIA (Bridgewater, 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 (Rahway, NJ)
- …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
- Compass Group, North America (New York, NY)
- …standards. This position is responsible for ensuring that all food safety, regulatory , and quality requirements are met, while maintaining the distinctive Kirkland & ... preventive controls, and all other prerequisite food safety standards, according to regulatory and Kirkland & Ellis requirements. + Oversee the Allergen Preventive… more
- Merck (Rahway, NJ)
- **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
- Hackensack Meridian Health (Edison, NJ)
- …compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. This role carries ... as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within… 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 (New York, NY)
- …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
