- Merck & Co. (Millsboro, DE)
- …for Proposals together with subsequent structured information analysis, using electronic procurement platform: ARIBA. Ensuring all Business Requirements are ... captured, lead the assessment of the proposals using predefined criteria derived from the Business Requirements.- Ensure Stakeholders are aligned with Assessments and Outcome.Negotiation Planning and Execution - to create detailed pre-negotiation plans, to… more
- Insmed Incorporated (NJ)
- …promotional material or medical review committee processes.Proven expertise with electronic material review systems (eg, Veeva PromoMats and/or MedComms)Strong ... understanding of applicable regulations governing promotional and non-promotional activities globally (FDA, EFPIA, ABPI, etc.).Demonstrated ability to lead in a matrix environment and manage complex workflows.Exceptional organizational and project management… more
- Insmed Incorporated (NJ)
- …of the documents being managed.Proficiency with Veeva or similar electronic document management systems.Strong attention to detail and organizational ... skills.Excellent written and verbal communication abilities.Knowledge of GMP and regulatory requirements.High interpersonal skills with strong communication and ability to work with cross functional teams. #LI-TB1 Pay Range:$81,000.00-103,000.00 AnnualLife at… more
- Merck & Co. (Rahway, NJ)
- …experience at the leadership level including the development of electronic submission deliverables.Designs and develops complex programming algorithms.Ability to ... comprehend analysis plans which may describe methodology to be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of… more
- Merck & Co. (North Wales, PA)
- …application submission experience including the development of electronic submission deliverablesExperience assuring programming consistency across protocols ... and projects, directing the program development effort of other programmers; experience as a programming mentorAbility and interest to work across cultures and geographiesAbility to complete statistical programming deliverables through the use of global… more
- Cipla (Central Islip, NY)
- …numbers, and other identifiers. Maintain sampling records in logbooks and electronic systems. Follow Standard Operating Procedures (SOPs) and Good Manufacturing ... Practices (GMP) during sampling. Adhere to safety and hygiene protocols in the sampling area. Store samples under specified conditions (temperature, humidity) to maintain integrity. Deliver samples to QC analysts for testing within defined timelines. Update… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to the QC laboratories.Perform peer review/approval of laboratory data.Utilize electronic systems (LIMS) for execution and documentation of testing.Create, review ... and approve relevant QC documents, SOP's and WI's.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Work in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …be responsible for management and delivery of the project plans for electronic batch record (EBR) updates and system improvements, support applicable process and ... facility updates, and support qualification activities associated with MES (PAS-X). This position will also be responsible for establishing and reporting on key project/program metrics in support of on time and on budget project deliverables.Key… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).Operational experience with electronic quality systems.Familiarity with core Quality Management System processes.Strong ... written and verbal communication skills, and analytical problem solving and conflict resolution skills.IT system lifecycle knowledge including requirements gathering, change management, implementation and continuous support is a plus.Flexible, highly… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …objectives.Ability to identify/remediate gaps in processes.Operational experience with electronic quality systems is required.Proficient with using Microsoft Office ... applications (Outlook, Excel, Word, and PowerPoint).#Li-DD1#Li-OnsiteThe anticipated base pay range is$107,482—$141,070 USDBenefitsWe are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain… more
