- Novo Nordisk Inc. (Plainsboro, NJ)
- …the development of a One Impact Planning strategy to optimize the therapeutic area product portfolio, aligning with the overarching corporate goals and market ... area objectives. Oversee day to day operations of the therapy area , including P&L budget management , resource allocation, and performance tracking.… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe US Vaccines business unit is a priority area for our company due to identified growth opportunities supported by vaccine launches and through ... US Vaccine BU (marketing and sales teams), Integrated Account Management , and the many Operational Headquarters extended teams to...C&DS Team in a newly created position as the Product Contracting & Marketing Owner (PCMO).- In this role,… more
- Novo Nordisk Inc. (WA)
- … identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes ... 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. (Irvine, CA)
- … identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes ... 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)
- …phases Perform ongoing and systematic surveillance of all accessible data within allocated product area (s), takes initial actions to mitigate risks in case a ... Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Novo Nordisk's product portfolio across its lifecycle and ensuring central management for the relevant therapy area . This role is responsible for ... of comprehensive lifecycle management plans for each product in the therapy area portfolio, considering...risk assessments to inform decision-making and prioritize initiatives Risk Management : Proactively identify and mitigate risks… more
- Merck & Co. (Rahway, NJ)
- …geo-political trends, and proactively directing policy development activities to mitigate risk and leverage opportunities in support of our company's business ... -Good Pharmacoepidemiology Practices (GPP) and the broader enterprise on above product policy and political issues, working closely with the Executive Director,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … product licenses (eg, Core Data Sheet generation/revision; clinical benefit- risk assessments for license renewals, responses to Health Authority)- Participant ... of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the internal and external network Manages Phase 1 -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … product licenses (eg, Core Data Sheet generation/revision; clinical benefit- risk assessments for license renewals, responses to Health Authority)Participant and ... medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external network. Manages Phase 1 -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …requirements, and industry best practices.Ensure /support the development of GLP/GCLP systems, risk management processes such as SOPs for QA activities for ... Audit and Compliance QA function to develop compliance and risk criteria, in order to assure compliance with regulations,...of global expectations of Health Authorities in the GxP area ; profound understanding of the science of product… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …is overall responsible for Line of Business leadership of the Medical and Science Area East Coast Hub team providing direction and ensuring development at area ... includes securing the right medical and scientific innovation level to ensure M&S area is a strategic partner in the projects and clinical drug development… more
- Merck & Co. (Millsboro, DE)
- …labeling and management of hazardous wastes, as appropriate to their area , providing you are properly trained prior to assignment.Demonstrates, at all times, ... one of the widest range of veterinary pharmaceuticals, vaccines and health management solutions and services.- The Millsboro, DE Animal Health facility is located… more
- Merck & Co. (Rahway, NJ)
- …formulation development and GMP clinical supply manufacture of our company's drug product pipeline.- The FLEx Non-Sterile Production Lead will steer this facility ... partnership with supply chain colleagues from Quality, Regulatory Affairs, Facilities Management , Engineering, and Analytical will be required to ensure effective… more
- Merck & Co. (North Wales, PA)
- …life-cycle management activities in the Neuroscience & Ophthalmology Therapeutic Area . The incumbent will be expected to lead multiple ophthalmology programs ... teams (eg Product Development Teams or similar)Strong leadership skills and management experience with a proven track record of hiring, mentoring, and retaining… more
- Merck & Co. (Durham, NC)
- …(including employee development, routine coaching sessions, recognition, and performance management ). Additionally, the selected individual must become proficient in ... site procedures to resolve process/equipment issues, minimize downtime, and ensure product quality.- This role actively supports, participates, and embraces an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Company and/or departmental expectations and goals as identified by senior management .Responsibilities- Acts as a brand attorney and lead legal advisor for the ... For these areas, acts as lead attorney for that area providing legal advice and support for the business...and for review, approval, and use by Legal Affairs management . Independently negotiates contracts and other issues with third… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respect to budget, timeline, achievement of defined milestones and overall project risk management . He/she will assess project issues and develop resolutions ... simultaneously. preferred- 4 or More Years Extensive experience in project management , process, product , and/or analytical development activities and… more
- Merck & Co. (North Wales, PA)
- …and Skills: Experience or training with developing KPIs and OKRs in the product modelHands-on experience with portfolio management and/or business performance ... role will initially focus on the Biostatistics and Research Decision Sciences functional area , with the growth potential to contribute to other functional areas. You… more
- Merck & Co. (Rahway, NJ)
- …drug delivery technologiesIs a recognized subject matter expert in at least one area of drug delivery and/or drug product manufacturing technologyThe desired ... scaling-up the formulation, device, and manufacturing process.- Driving drug product design from the bench top to the Good...of Experiments for new chemical entities or life cycle management opportunities while also helping to coach others in… more
- Merck & Co. (Durham, NC)
- …GENERAL PROFILE: Ensure effective technical support to the Laboratory Operations area , manage project work to ensure analytical robustness, work standardization and ... for maintaining a safe work environment Meeting and driving projects and change management ensuring technical support needs are met Schedule adherence and right the… more
