- Aequor (Newbury Park, CA)
- …in SharePoint, has working experience with the Six Sigma method and project management experience. The type of qualities/characteristics the hiring manager is ... tasks, which requires resourcefulness and critical thinking skills.) Job Title: Sr . Associate - Records Information Management & Systems (RIMS)Job DescriptionKey… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development. ... product programs under your leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … agencies. Supervise designated personnel. Relationships Report to the Director/Associate Director/ Lead Regulatory Scientist/ Sr . Manager Regulatory ... FDA meetings (pre-IND, EOP 2, pre-NDA, pre-BLA) for review by Project Leaders Write Regulatory documents translating team strategy into regulatory overview… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director ( Sr . Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and focus to agreed strategy; Coordinates clinical activities across the project ; Represents IPT to Sr . ManagementAdditional non-study related activities: ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … project needs and the respective development stage of the project . The CMC Lead will support the Sr . CMC Lead on complex and/or late-stage project ... and stakeholder satisfactions. Responsible to communicate and escalate to Senior CMC Lead regarding the activity status...to lead teams within overall CMC development project (s), to support Sr CMC Lead… more
- Merck & Co. (North Wales, PA)
- …is responsible for developing medical writing deliverables that support the clinical regulatory writing portfolio. With minimal oversight, the Senior Medical ... Job DescriptionPosition Description: Senior Medical Writer The Senior Medical...investigator's brochures, clinical sections of submissions) per company and regulatory requirements. Applies an in-depth knowledge of medical writing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …As a result, this role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as well as cross-functional stakeholders (eg, ... business requirements for reporting and analyticsEngage with key stakeholders, including Regulatory Affairs teams and cross-functional project team members, to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coordination and focus to agreed strategy; Coordinates clinical activities across the project ; Represents IPT to Sr . ManagementPeople Management: Leads large ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Fermentation Operations Technician (Days) This position is in direct support of our Upstream Fermentation manufacturing ... Filtration, Process Monitoring, Sampling, and area cleaning. As a Senior Technician you will be an energetic leader with...the manufacturing process. Individual will possess the ability to lead a small team, train others and contribute to… more
- Merck & Co. (Durham, NC)
- Job DescriptionJob DescriptionThis role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug ... team finishes design and construction of the facility, the Senior Technician will play a critical role in supporting...input in the design process, startup their areas, and lead the teams to full production.Our ability to excel… more
- Merck & Co. (Millsboro, DE)
- …Quality and Business support at the Millsboro site. The Site Digital Technology Lead ensures all project and commercial manufacturing activities are supported ... Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal… more
- Eisai, Inc (NJ)
- …you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, ... protocols, and protocol amendments often acting as the compound leadLead project management for medical writing deliverable by defining milestones, managing budget,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …analytics and software tools Experience with management of external partners Strong project management skills to lead and oversee multiple initiatives from ... with us? The Position The Diagnostics and Precision Health Lead will be responsible for developing and implementing a...landscape of healthcare and technology integration. This is a senior level strategic thinker who is leading a complex… more
- Catalent (Harman, WV)
- Senior Director, Supply Chain Position Summary: The Senior Director, Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management including,… more
- Eisai, Inc (Nutley, NJ)
- …communicated to and executed by internal business partners and external agenciesPotentially Lead or Co- lead cross-functional project teams involving ... matrix environment; strong ability to influenceDemonstrated ability to effectively lead cross-functional project teamsStrong written and verbal communication… more
- Novo Nordisk Inc. (Durham, NC)
- …driving the stability portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director. Essential Functions Lead , drive & ... relationships with team members & other teams Ability to lead task & project teams Ability to...for their contributions & successes Effectively uses rewards & recognition to help individuals & team achieve desired results… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo, ... development is the cross functional, empowered and agile Global Project Team (GPT), directly accountable to global Development governance....In this key role, the candidate will have to lead a complex, global team in charge of a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross functional ... timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction...quality metrics and share with study team, Operations Program Lead , and Sr . Director for the compound,… more
- Piper Companies (Philadelphia, PA)
- Piper Companies is currently seeking a Sr . Regulatory Operations Specialist to support a growing and innovative cell and gene therapy company in Philadelphia, PA ... (Hybrid Schedule). Responsibilities for the Sr . Regulatory Operations Specialist...and develop content plans for IND & CTA dossiers.. Lead interactions with external publishing teams to compile IND… more
