- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on quality, reliability, consistency and efficiency.ResponsibilitiesPlan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory ... meeting, creates response templates and coordinates processes for authoring and review of response as appropriateProvide support or coordinate other regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and organization of team's townhall meetings.- Facilitate the multiple level of compound review meetings and other review committee meetings.- Drive all Global ... CR2 Leadership meetings with efficiency with action item published timely and plan agendas weeks ahead of schedule.- PM/OE Team Management and Development, Vendor Oversight:- Lead and manage a team of Project Managers, providing guidance, coaching, and… more
- Merck & Co. (Boston, MA)
- …TMed at governance for the Immunology portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of external-based ... as the deep subject matter expertise in Translational Immunology.Immunology Discovery Review core member.Represent TMed at core governance (early and late… more
- Merck & Co. (Rahway, NJ)
- …governance for the Cardiovascular & Respiratory portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of ... subject matter expertise in Translational Cardiovascular & Respiratory Medicine CMD Discovery Review core member Represent TMed at core governance (early and late… more
- Novo Nordisk Inc. (Boulder, CO)
- …Manage manufacturing of phosphoramidites at suppliers for multiple programs. Review manufacturing updates and reports from vendors. Independently evaluate, plan ... key custom phosphoramidites and raw materials at vendors. Write RFPs and review quotations. Strategize and initiate cost saving and sourcing intelligence for… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …for all NNUSBPI products. This position has QA signature authority on the review of individual batch records, supporting test records and other ancillary support ... with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support of ongoing technical transfer and manufacturing operations. Write and/or review manufacturing process transfer plans, protocols, and reports. Design studies, ... support and manage applicable change controls. Technical assessor of change controls. Provide review of process flow diagrams as well as protocol and reports from… more
- Catalent (St. Petersburg, FL)
- …to the QMS.The QA Manager is responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: a) ... of functions across the site and with clients to drive timely review , approval, and closure of investigations, change controls, audit tasks, corrections, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timely basis. Management and oversight of Clinical Development contracting process, review and approval in accordance with company policies.Procurement - Manages all ... formal people manager). Develops detailed bid analysis for the RD functional group's review . Development and management of other ad hoc special projects as they… more
- Catalent (NJ)
- …prospects. Prepare marketing & technical presentations, as well as, Business Review presentations for existing customers and internal meetings.Attend global or local ... people focused cultureGlobal exposure, defined career path and annual performance review and feedback processCompetitive Medical, Dental, Vision and 401K19 days PTO… more
