- Merck & Co. (North Wales, PA)
- …The Principal Scientist / Director responsibilities include but are not limited to:Serve as a Regulatory CMC Project Lead and provide CMC Regulatory ... regulatory strategies and provides mentoring and coaching to Sr . Scientist and Assoc Principle scientist in support of...CMC guidelines regarding IND/BLAs or post approval changes.The CMC Project Lead is accountable for the delivery… 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
- 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
- Aequor (Thousand Oaks, CA)
- The Supply Chain Project Manager (SCPM) will translate product variation strategy as determined by the Variation Lead for reportable changes for Global ... translate product launch/variation strategy as determined by the Regional Operations Lead to an executable implementation plan for launch/variation changes for… 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
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior Specialist Manufacturing Automation person is primarily responsible ... the automation systems in compliance with cGMPs. The Manufacturing Automation Sr . Specialist must actively support, participate and embrace an empowered team… more
- Merck & Co. (Rahway, NJ)
- …benefit of patients and global human health. Responsibilities :Serves as a statistical lead in project teams. Lead , develops, coordinates, and provides ... biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical, Regulatory , Statistical Programming,… 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
- Insmed Incorporated (Bridgewater, NJ)
- …15 years of experience as a regulatory toxicologist (study director/monitor and/or project lead ) in the pharmaceutical or biotechnology industry or within a ... safety studies outsourced to contract research organizations.Provide strategic input to project teams and senior management regarding the potential impact… 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
- 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
- Merck & Co. (Rahway, NJ)
- …Organization (CRO) and external statistical consultants.This position may serve as a statistical lead in project teams.The incumbent may initially work in a ... for the strategic planning and execution for product development and worldwide regulatory submissions. Lead a team of statisticians and the statistical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of scientific, ... regulatory , and business perspectives to ensure compliance with evolving...that incorporates input from cross-functional subject matter experts and senior leadership at Daiichi Sankyo and relevant external collaborators/alliance… more
- Merck & Co. (Rahway, NJ)
- …culture, talent development, technology introduction, and compliance.- However, one co- lead remains focused on non-sterile pipeline programs and infrastructure while ... one co- lead remains focused on sterile pipeline programs and infrastructure.-...compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program support, financial, talent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Paid Media, Medical, Managed Markets, Corporate Communications and Public Affairs, Regulatory , Privacy, Sales, and Legal. Will also interact with NNA/S on ... across multiple therapeutic areas/brands to ensure scalability, cost savings and alignment Lead and/or participate in key TA/Brand governance teams as well as… more
- Merck & Co. (North Wales, PA)
- …maintained and preserved.- Under the oversight of the System and Data Integration Lead (SDIL), the Associate SDIL is responsible for the integration between our ... processes as well as preparing for, management and follow up of regulatory inspections Educational Requirements: - Required: Bachelor's degree in science or… more
- Eisai, Inc (Nutley, NJ)
- …Responsibilities Interaction & Collaboration level: Requires interaction with vendors and key senior stakeholders at Sr manager and director level in sales, ... developing team members to perform effectively in their roles.He/she serves as the lead point-person and training subject matter expert with the commercial brand and… more
- Merck & Co. (Rahway, NJ)
- …development, and/or engineering and regulatory science.Proven ability to lead program development teams using project management skills.Preferred Experience ... SkillsKnowledgeable of the Capital Process having participated on a large capital project team.Experience in regulatory compliance expectations across all phases… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead ; supports Phase 2/3 clinical pharmacology objectives with ... in due diligence activities and represents global function on study and project teamsProduces independent writing for publications & regulatory documentsServes… more
- Insmed Incorporated (Bridgewater, NJ)
- …10 years of experience as a regulatory toxicologist (study director/monitor and/or project lead ) in the pharmaceutical or biotechnology industry or within a ... 10 years of experience as a regulatory toxicologist (study director/monitor and/or project lead ) in the pharmaceutical or biotechnology industry or within a … more
