- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education Qualifications (from an accredited college or ... Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Merck & Co. (Rahway, NJ)
- …regulations and our Company procedures. They will also collaborate with the Quality Program Lead to issue reports summarizing results, works with area to ... and/or out-of-specification approval, change management approval, etc.Support the Quality Program Lead on inter-departmental and cross-functional teams, ensuring… more
- Formation Bio (New York, NY)
- …direction, and support to cross-functional teams in a matrixed environment. Partner with the Program Leader to support and/or co- lead the program Drive ... faster and more efficiently.About the PositionWe are seeking an Associate Director, Program Management to drive the execution of critical drug development programs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …quality and/or timelines at the study level and escalates issues to the DM program lead .- Will manage DM resources of assigned studies; provides FSP/Vendor ... and determines and coordinates mitigation activities; escalates issues to DM Program Lead as needed.- Attends study team meetings and provides information on… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently. About the PositionAs a Lead Product Manager, you will help execute on our tech strategy through 0-to-1 ... with colleagues throughout the company, including our Medical/R&D, Biometrics, Clinical Program Management, and Clinical Operations teams to help identify solutions… more
- Eisai, Inc (Nutley, NJ)
- …track record as Study Director (or equivalent role) with Global Clinical Lead or Clinical Program Director accountability. Proven experience in running ... Clinical Development resides within the Oncology at Eisai. This Executive Director will lead franchise programs, and will be the clinical group leader for the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in Raritan, NJ. Role OverviewThe ... Quality Systems Lead role is an exempt level position with responsibilities...quality systems processes.Key Responsibilities Provide oversight to the CAPA program for the CAR-T manufacturing site.Oversee metrics, trending, and… more
- Eisai, Inc (Nutley, NJ)
- …development and performance management of staff. Determining timelines and budgets for program activities and report accordingly. Lead and participate in global ... of GRS teams responsible for large, late stage development program or for multiple early stage development programs. Using...cycle management of existing products. May serve as the lead regulatory representative on the project team throughout the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description The Senior Scientist, Device Design Control Lead , is a crucial member of our team, responsible for spearheading design control efforts ... be responsible for device design control activities in the following aspects: Lead and contribute device development design controls for the assigned projects.-… more
- Merck & Co. (Rahway, NJ)
- …effective, efficient, and seamless cross-functional collaboration to deliver novel strategic program and study design, analysis strategy, and analysis results with ... statistical techniques and methodologiesMentors team statisticians in developing adaptive program -level statistical strategies, ensuring alignment with rapidly evolving field,… more
- Merck & Co. (Rahway, NJ)
- …proven talent development skills. Extensive experience as a drug substance lead for biologics pipeline programs. Strong capability in managing evolving timelines, ... program risks and mitigation strategies. In-depth knowledge in upstream...ensure the team alignment with functional objectives.Ability to communicate program progress, issues, and mitigation plans to the senior… more
- Merck & Co. (Rahway, NJ)
- …offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be ... team of approximately 5-10 pharmacometricians to achieve results on major program drivers by identifying and implementing quantitative approaches (for eg,… more
- Merck & Co. (Rahway, NJ)
- …management skills.Job-Specific Competencies & SkillsDemonstrated ability to understand, manage and lead in a multi-cultural atmosphere, with an employee base that is ... Common Technical Document (eCTD), Ethical Compliance, Global Health, Global Program Development, High Performance Team Building, Human Resource Management,… more
- Merck & Co. (Rahway, NJ)
- …technology to positively impact patients.The Director of Oral Formulation Sciences will lead a team of scientists and engineers responsible for the formulation and ... our oral product pipeline. The individual will be accountable for driving program strategy and translating into effective execution from discovery exit through… more
- Merck & Co. (Rahway, NJ)
- …indicators that demonstrate improvements. Change Management: Utilizes outstanding project, program and change management skills to manage and drive change ... adaptable in dealing with ambiguous and complex environmentsAble to effectively lead diverse, cross-functional teams to achieve stakeholder, department, and company… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Specialty Medicine portfolios, in alignment with the business strategy Lead the DSG inspection management activities by ensuring continued submission, compliance ... of Quality professionals at strategic non-project team and at MA strategic discussions. Lead the Quality Reviews of respective product profile to ensure appropriate… more
- Eisai, Inc (Nutley, NJ)
- …data monitoring to ensure successful implementation of high-quality clinical development programs. Lead and manage moderately complex clinical research areas and may ... occasionally be responsible for program oversight.Serve as a medical monitor and provide input...conferences, competitive intelligence activities and engaging in periodic literature review. Lead processes for team management in terms of goal… more
- Eisai, Inc (Nutley, NJ)
- …hear from you. The Regional Thought Leader Liaison (RTLL), Alzheimer's Disease will lead and execute regional and local engagement with existing and emerging Key ... promotional speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non-clinical ... development staff.Consults with KEE's for advice on complex patient safety issues. Communications lead with HCP's (PI's, sub- PI's, nurses) at the site level to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check ... Initiates contact w/KOL and prepares material for KOL interactions on a program based need; Involvement with in-licensing and acquisitions on individual due… more
