- Daiichi Sankyo, Inc. (Bernards, NJ)
- …US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global ... research areas centered around rare diseases and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global ... of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider… more
- Merck & Co. (Durham, NC)
- …finished product, and laboratory testing for the BCG vaccine.The Quality Operations Laboratory Manager leads a team of analysts in the start-up and method transfer ... candidate will report to the Associate Director, Laboratory Operations to lead start-up new laboratories for microbiological testing and environmental monitoring.-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Data Standards is responsible for the development and sustainability ... also some of the requirements of this role. The Manager , Clinical Data Standards should be a subject matter...bodies to ensure DS Data Standards are aligned with regulatory requirements and the organizational policies and procedures. Promotes… 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
- Merck & Co. (Boston, MA)
- …and advance the drug discovery and development pipeline.As an IT Product Technical Lead within the Disease Biology and PharmTox (DBPT) Product Line, you will enable ... our mission to serve patients.Primary Tasks:Partner with Molecular Profiling Product Manager to understand, prioritize and develop strategically aligned IT solutions… more
- Aequor (Golden Valley, MN)
- …This is a hybrid role Full-Time We are seeking an experienced and motivated Project Manager to lead the refresh and update of our Supplier Code of Conduct. ... of Conduct to identify areas for improvement. Research industry standards and regulatory requirements to ensure the updated Code meets or exceeds current… more
- Lundbeck (Walford, IA)
- …mindset, where employees are empowered to take educated risks that could lead to significant breakthroughs. Our nimbleness and ability allow us to respond ... pharma. We are offering an exceptional opportunity to join Lundbeck as Medical Manager . If you're passionate about working in a collaborative environment and want to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to make a difference? The Position We are looking to hire a Clinical Project Manager (CPM). This is a unique opportunity to work in a growing Clinical Operations ... study protocol, and identifying areas of concern and escalating to Clinical Program Lead when appropriate Collaborate with the Clinical Program Lead and study… more
- Eisai, Inc (Nutley, NJ)
- … / non- regulatory change review and change management process.Team Leadership: Lead the global teams in the execution of Risk and Compliance initiatives and ... you.The Director, Global IT Governance, Risk & Controls Management Lead is responsible for overseeing the entire portfolio of...s/he is the Global IT department's trusted leader and manager who assesses and provides objective risk assessments and… more
- Lundbeck (Murfreesboro, TN)
- …and transform lives. Join us on our journey of growth!As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Associate Manager as part of the Quality team based in Raritan, NJ. Role ... Leadership Team members, and peers.Independently makes appropriate and compliant GMP decisions. Lead the establishment and improvement of QA practices to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary The Non-Regulated Implementation Services Lead is responsible for the strategic oversight, planning, and execution of ... services are developed, implemented, tested, and integrated efficiently and effectively. The Lead will define and drive the methodology, approach, and best practices… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Consumer CX Manager will be a critical driver in ensuring the successful execution of brand/therapy area ... support patient services initiatives. Relationships Reports to Consumer Experience Lead . Collaborates with key external and internal cross-functional teams,… more
- Lundbeck (Houston, TX)
- …lead the way in creating positive customer experiences!As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand ... Environment/Compliance - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations… more
- BioAgilytix (Durham, NC)
- …from planning to post-implementation support, with a strong focus on regulatory compliance and lab efficiency.Key ResponsibilitiesProject Leadership: Lead the ... The LIMS Project Manager at BioAgilytix will oversee the comprehensive implementation,...for BioAgilytix staff to ensure effective system adoption and usage. Regulatory Compliance: Ensure that the LIMS implementation complies with… more
- Merck & Co. (Durham, NC)
- …on time approval of payroll activities using site approved software like ADP. Lead and support daily meetings to facilitate flow of information up/down through the ... issues impacting supply within the daily, weekly, and monthly IPT management processes. Actively lead the daily Tier 1 Process and participate in the Tier 2, as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. 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. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager , Bio Sample Operations is responsible for supporting the oversight of the ... and/or support identification of trends in biosample queries and lead /support implementation of improvements to mitigate recurring queries. Support activities… more
- Aequor (Thousand Oaks, CA)
- …on time. The qualified candidate will support verification, validation, and regulatory submissions of these devices. Work within a cross-functional organization to ... continuously integrate for predictable execution and teamwork across all functions.Responsibilities: Lead medium/small projects independently and work directly with Program… more
