- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director, Business System Labeling Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory ... Affairs Operations with Labeling Process and/or Digital Enablement experience strongly preferred, and...Description: Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS Regulatory Innovation &… more
- Genmab (NJ)
- …fit? Then we would love to have you join us!The Global Regulatory Labeling , Policy and Intelligence Associate Director will primarily be responsible for leading the ... development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC...Affairs (GRA) and will report to the Sr. Director, Labeling , Policy and Intelligence. The position may be based… more
- Aequor (Hicksville, OH)
- …Accepts and controls labels for individual orders. Counts and verifies labeling , packaging components and finished product against pick list, material list ... report, and palletizing pattern. Processes paperwork for Labeling Returns and brings returns to the Label Room...Safety (BBS) goals. Note: This position may require the labeling , packaging or movement of hazardous (flammable, corrosive, toxic,… more
- Merck & Co. (Rahway, NJ)
- …of clinical trial s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The GCS ... Goods).- - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support… more
- Merck & Co. (Rahway, NJ)
- …of clinical trial s .- GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites globally. The GCS ... Teams . - Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support… more
- Repligen (Hopkinton, IA)
- …visual inspections, operating manual and automated machinery, and completing packaging and labeling activities. The successful candidate will play a key role in ... ensuring that the department's safety, quality, and production goals are met.ResponsibilitiesSupervise and coordinate the activities of production line workers.Enforce safety regulations and ensure the work area is clean and organized.Ensure production goals,… more
- Repligen (Hopkinton, IA)
- …visual inspections, operating manual and automated machinery, and completing packaging and labeling activities. The successful candidate will play a key role in ... ensuring that the department's safety, quality, and production goals are met.ResponsibilitiesConduct basic assembly techniquesRead manufacturing drawings and follow standard operating procedures of varying complexityPerform detailed visual inspections on… more
- Repligen (Hopkinton, IA)
- …label(s) to approved production materials according to the inventory part labeling specification. Requires demonstrated use of inspection tools (ie: Calipers, ... Micro-hite, rulers etc.)Working Knowledge of sampling plan(s).Requires verbal or written communication to management of all Non-Conforming Material.Reject any non-conforming material and support Root Cause Investigations.Good organization skills and Microsoft… more
- Merck & Co. (Rahway, NJ)
- …10+ years equivalent industry experience in Pharmaceutical Clinical Supply (packaging, labeling , logistics and clinical supply inventory management) --At least 5 ... years of experience in project management -At least 5 years of experience in planning, scheduling, coordination and processing of supply chain activities, or the equivalent -Excellent Communication & Interpersonal Skills: ability to effectively communicate… more
- Aequor (Hicksville, OH)
- …Corporate quality and safety Behaviors. Note: This position may require the labeling , packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste ... within the facility. If so, this employee must be trained under OSHA's HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander. In lieu of HAZWOPER training, the employee will receive… more
- Aequor (Hicksville, OH)
- …Corporate quality and safety Behaviors. Note: This position may require the labeling , packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste ... within the facility. If so, employee requires training under OSHA's HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander. In lieu of HAZWOPER training, the employee will receive training… more
- Aequor (Hicksville, OH)
- …DEA, FDA, EMEA, ANVISA, HS&E, etc.) Note: This position may require the labeling , packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within ... the facility. If so, this employee would be trained under OSHA's HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander. In lieu of HAZWOPER training, the employee will receive training on… more
- Twist BioScience (South San Francisco, CA)
- …documentation, with a primary focus on Safety Data Sheets (SDS), product labeling , and SOP's. This role is crucial in supporting global product compliance, ... ensuring that all documentation accurately reflects regulatory requirements and product specifications.What You'll Be Doing Initiate, author, and maintain Safety Data Sheets (SDS) for all Twist products, ensuring compliance with global regulations. Collaborate… more
- Eisai, Inc (Nutley, NJ)
- …on the cutting edge of data readouts (consistent with FDA-approved labeling ), medical congress meeting outputs and podium & symposia presentations.Identify best ... practices to help Simplify the Patient JourneyEngage with KOLs affiliated with key regional health systems to understand best practices for establishing diagnostic and treatment algorithmsHelp develop case studies and share with health system C-suite to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with research laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard ... problems of some complexity. This position makes decisions with consultation. Responsibilities:Planning for Development : Manages multiple CMC development projects. Leads submission teams with supervision. Acts as point of contact to cross-functional teams on… more
- Bayer (Whippany, NJ)
- …minds to make a real difference, there's only one choice.** **Director US Labeling & Registration** The Director US Labeling & Registration is responsible ... for the creation and maintenance of local labeling documents in accordance with the Company Core Data...addition, manages the preparation and compilation of all US labeling documents relevant for registrations and supplements and manages… more
- Takeda Pharmaceuticals (Boston, MA)
- …life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and ... implementation of labeling content and strategy of multiple products in various...and EU SmPC. **How you will contribute:** **Management of Labeling Cross-Functional Teams** + Leads Labeling cross-functional… more
- Stryker (WA)
- As the Staff Technical Writer & Labeling Specialist supporting the Stryker Sustainability Solutions (SSS) Business Unit within the Endoscopy Division, you will ... tools or company-specific software. You will also evaluate medical device labeling to ensure compliance with domestic and international regulations. To learn… more
- Pfizer (Groton, CT)
- The **Senior Manager, Global Labeling Lead (GLL)** has overall accountability for the development and execution of global labeling strategy for their assigned ... products. This includes managing the end-to-end process of Target Labeling in early development, creation and maintenance of Core Data Sheets (CDS), and submission… more
- J&J Family of Companies (Raritan, NJ)
- …submission. Johnson & Johnson Innovative Medicine R&D is recruiting for a Manager, Global Labeling Product Leader. This position is a hybrid role and can be located ... in Raritan, NJ; Titusville, NJ; or Horsham, PA. The Manager, Global Labeling Product Leader will be responsible for the following: + Lead the development, revision,… more
