- Eisai, Inc (NJ)
- …for and assures follow up of adverse event reports that potentially impact the safety profile of product area responsibility. Interacts with staff at other Eisai ... documenting and processing adverse event reports received for assigned product , including the timely review and distribution to co-marketing...and co-marketing partner Safety offices, healthcare professionals and consumers to obtain and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …risk management for assigned clinical studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead (PSL), Clinical Safety ... studies in partnership with Clinical Safety Scientist Product Lead, Product Safety Lead...Lead and PSL - May serve as a project manager for other activities involving assigned product (s)… more
- Catalent (St. Petersburg, FL)
- QA Product ManagerPosition Summary The QA Product Manager provides customer service, with the highest integrity, focused on quality and compliance with ... clients within the Catalent St. Petersburg site. The QA Product Manager is responsible for the overall...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA ...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and ... Product Batch Release, and Change Control.The QA Product Manager provides customer service, with the...of our recruitment and on-boarding processes to maintain everyone's safety . The Human Resources teams will communicate all necessary… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe role of Operations Manager at our Company's Durham facility is a manufacturing leadership role. The individual in this role must provide ... in order to resolve process/equipment issues, minimize downtime, and ensure product quality.This role will support manufacturing activities at the Durham Site.… more
- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies ... Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of... to create and sustain a site culture of Safety , Quality performance, Operational Excellence, continuous improvement, error reduction,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …NNI. Key relationships include Medical & Scientific Affairs, Field Medical Affairs, Product Safety , Customer Care, Sales, and Marketing. Essential Functions ... FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... of all contract and vendor related activities in Patient Safety including, but not limited to, contract review and...contract review and vendor management support in regards to safety reporting. To serves as a liaison between NNI… more
- Aequor (Thousand Oaks, CA)
- FULLY REMOTE Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on product teams, lead writing activities for ... With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... and standardizing data, with a focus on eg, clinical, product , and vendor data and Identify and rectify data...Electronic Records, Electronic Signatures o 21 CFR 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... through execution of data analytics and market research with customers. The CI&A manager will work and collaborate with multiple levels of management and cross… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready to realize your potential? The Position The Manager - Market Access Insights assesses product and customer performance for ... while innovating for future capabilities. We regulate accounting, uphold workplace safety , manage our supply chain and sampling, support technology, provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Manager of Operations - Continuous Improvement and Projects as part of the Technical ... project management to enable robust production, testing and release of product to patients. Key Responsibilities Plans, leads, develops, provides expertise, trains,… more
- Catalent (St. Petersburg, FL)
- …has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.II. Basic Function: This position is ... responsible for managing and documenting events / discrepancies associated with either product or process as well as managing / writing any investigations that may… more
- Aequor (New Brunswick, NJ)
- Job Description: Hybrid- Minimum 60% onsite( Manager is onsite Mon, Tues, Thur and worker needs to be onsite these days) Activities include: Work with supply chain ... planners, strategic product leads and other key stakeholders, to execute the...to execute the process for periodically refreshing and implementing safety stocks. Facilitate meetings to collect inputs impacting the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators ... ensuring consistent quality standards are maintained. Key Responsibilities Support area Manager and work closely with investigators to ensure investigations are… more
- Merck & Co. (Ames, IA)
- …problems.Planning and scheduling of pre-license serials, engineering batches, and field safety trial batches in production in coordination with cross functional ... orders as required based on schedule/inventory changes.Coordinate material flows throughout product /BOM changes, obsolescence, and/or materials due to new product… more
- Novo Nordisk Inc. (Atlanta, GA)
- …FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to ... Drives the understanding and delivery of quality clinical research (patient safety , rights and wellbeing; data reliability; scientific integrity; regulatory and… more
- Merck & Co. (North Wales, PA)
- …single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product regulatory ... by regulatory agencies for multiple indications simultaneously.Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they… more
- Catalent (Philadelphia, PA)
- …throughout our global network. Packaging can be configured to hold a single product or multiple products as determined by study requirements. We offer manual patient ... through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The...and Catalent employee. The Role Support activities of the Manager , Training Program and the Training Lead.Cross train with… more
