- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible... industry ) is preferred1 or more years of industry experience within regulatory is preferredOrganized and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Provide proactive support and technical assistance during preparation and review of regulatory documents As assigned, participate in project teams Assist with ... Works with manager to compose letters incorporating NN position on external regulatory initiatives Works with Group Manager to maintain surveillance of … more
- Aequor (Newbury Park, CA)
- This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works regular hours (7a-4p or 8am-5p etc)/ with EST timezone ... in SharePoint, has working experience with the Six Sigma method and project management experience. The type of qualities/characteristics the hiring manager … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …most recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO) Previous experience leading ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North America Clinical Development (NACD).… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position has a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received ... this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies… more
- Aequor (NJ)
- …Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory , CMC, ... 100 % remote Manager prefers local candidates (will consider non local...phases 1-4. The individual must partner closely with clinical, regulatory , quality and production associates to ensure timely delivery… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Outsourcing). Contribute to the Daiichi Sankyo validation strategy by considering regulatory requirements, industry best practices and company policies and ... Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology ... (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management, is accountable for an end-to-end delivery of ... for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. The position will perform validation of the electronically… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Visio, Power Point), training systems, and metrics dashboarding preferred- Understanding of industry trends (eg, regulatory , technology) with ability to apply ... areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Manager , NextGen Customer Engagement will support Novo Nordisk's strong commitment to its customers ... such as Marketing, Field Execution, Field Systems, Advanced Analytics, IT, Legal, Regulatory , as well as external vendors. Essential Functions Enable the NextGen… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... protocols, and protocol amendments often acting as the compound leadLead project management for medical writing deliverable by defining milestones, managing budget,… more
- Lundbeck (Chicago, IL)
- …of growth!Open to candidates anywhere in the greater United StatesSUMMARY:The Senior Manager Sales Training and Development is primarily responsible for managing the ... sales management training needs by observing individual Biopharmaceutical Account Manager performance/behaviors and collaborating with the appropriate functional areas… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining ... etc., under the direction of Director, Compliance Policy, Training and Communications. Project manage various teams to build creative training programs from… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Durham, NC)
- …the stability portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director. Essential Functions Lead, drive & coach teams ... seven (7) years of leadership/management experience in the pharmaceutical industry /and or pharmaceutical chemistry laboratory required Technology transfers within… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Work closely with internal statistical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sensitive documents that may impact multiple Global organizational units or Global project teams. This position has advanced skills in technology systems, including ... projects assigned to individuals are current and up to date- Support regulatory inspection related activities as required such as organizing CAPA coordination teams,… more
- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations.General Compliance Activities:Maintain an inventory of ... play a pivotal role in ensuring the organization's adherence to security, regulatory , and compliance standards. Collaborating with business and EIT stakeholders, you… more
