- Merck & Co. (North Wales, PA)
- …cross functional partners and peers to align on strategic planning, launch readiness , and continuous evolution of PSP strategy, ensuring data-driven insights inform ... & Innovation to ensure PSP design integration and data ecosystem readiness .- PSP Performance Measurement Framework: Collaborate to establish and oversee PSP… more
- Insmed Incorporated (NJ)
- …ensuring compliance with document management standards, version control, and audit readiness .Coordinate the intake, formatting, and QC of regulatory documents prior ... with Veeva Submissions Vault for document management and submission readiness .Hands-on experience with eCTD publishing tools (eg, Lorenz, GlobalSubmit, Extedo,… more
- Insmed Incorporated (NJ)
- …shaping and executing the professional marketing strategy to ensure successful US launch readiness and long-term adoption. This role is focused on the US market.This ... to be delivered through a comprehensive launch planSupport franchise launch readiness by representing the brand in go-to-market and organizational design buildsBuild… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and collaborate closely with Operations Associates and Management to facilitate readiness of trainees and effective process qualifications. The role will require ... cross functional groups to enable robust training, regulatory compliance, team readiness , and processing of product prior to release to patients.Key… more
- Insmed Incorporated (NJ)
- …their lifecycle a plus .Familiarity with validation of documentation, audit readiness , and continuous improvement of CSV processes. Risk Management: Define and ... with GxP regulations and industry standardsFamiliarity with validation of documentation, audit readiness , and continuous improvement of CSV processes a plus . Team &… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …this role will support Compliance initiatives, such as inspection readiness , metrics implementation and review, overall regulatory compliance and implementation ... to stay informed of regulatory trends and developmentsAssist with inspection readiness efforts and program implementation across all sites.Manage and support the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and collaborate closely with Operations Associates and Management to facilitate readiness of trainees and effective process qualifications. The role will require ... cross functional groups to enable robust training, regulatory compliance, team readiness , and processing of product prior to release to patients.Schedule: Mon-Fri,… more
- Insmed Incorporated (NJ)
- …shaping and executing the professional marketing strategy to ensure successful US launch readiness and long-term adoption. This role is focused on the US market.This ... teams, ensuring brand messaging is aligned as appropriate.Lead integrated US launch readiness for HCP and payer channels and represent brensocatib in go-to-market… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and manage change controls and maintain permanent inspection readiness and actively support regulatory inspections.Ensure investigations are processing ... and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition… more
- Insmed Incorporated (NJ)
- …partners closely stakeholders across the organization to drive succession and readiness strategies, ensuring bench strength for critical leadership roles and ... multi-year roadmap to ensure bench strength and creating individualized succession readiness plansCollaborate with TA team to align recruitment strategies with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …project initiatives.Supports any business improvement efforts.Supports permanent inspection readiness and actively supports internal audits and regulatory ... and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition… more
- Merck & Co. (Millsboro, DE)
- …strong process performance monitoring, deviation triage, CAPA effectiveness, and readiness for regulatory inspectionsBuild and develop high-performing teams; coach ... dental, vision healthcare and other insurance benefits (for employee and family ), retirement benefits, including 401(k), paid holidays, vacation, and compassionate… more
- Merck & Co. (Rahway, NJ)
- …from concept generation/selection, development, verification, and validation to launch readiness :Lead the cross-functional Device Working Groups to ensure full ... dental, vision healthcare and other insurance benefits (for employee and family ), retirement benefits, including 401(k), paid holidays, vacation, and compassionate… more
- Insmed Incorporated (NJ)
- …result in manufacturable, scalable, and compliant processes while maintaining supply chain readiness for both clinical and commercial needs. You will support global ... Assistance Program (EAP)Generous paid time off policies, fertility and family -forming benefits, caregiver support, and flexible work schedules with purposeful… more
- Insmed Incorporated (NJ)
- …devices. A critical aspect of this role involves ensuring manufacturing readiness for both clinical and commercial supply chains.Your responsibilities will include ... Assistance Program (EAP)Generous paid time off policies, fertility and family -forming benefits, caregiver support, and flexible work schedules with purposeful… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …closure and product release.Support regulatory inspections and audits by ensuring inspection readiness within facility and serving as an SME during the execution of ... and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition… more
- Syner-G BioPharma Group (Boston, MA)
- …across facilities.Support business continuity planning and emergency response readiness .QUALIFICATIONS AND REQUIREMENTS: To perform this job successfully, an ... color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political… more
- Insmed Incorporated (NJ)
- …and develop team members. Proactively plan for the future to ensure readiness and effectiveness of the team.Strategy Development -Partner across medical affairs and ... Assistance Program (EAP)Generous paid time off policies, fertility and family -forming benefits, caregiver support, and flexible work schedules with purposeful… more
- Insmed Incorporated (NJ)
- …Supply Chain to ensure compliance with eTMF documentation and audit readiness activitiesSupport regulatory filings (IND/CTA/IMPD), act as SME during inspections, ... Assistance Program (EAP)Generous paid time off policies, fertility and family -forming benefits, caregiver support, and flexible work schedules with purposeful… more
- Insmed Incorporated (NJ)
- …management and leadershipEnsure electronic notebook record and technical report readiness to enable smooth IND development processContinuously and proactively ... Assistance Program (EAP)Generous paid time off policies, fertility and family -forming benefits, caregiver support, and flexible work schedules with purposeful… more
