- Novo Nordisk Inc. (Plainsboro, NJ)
- …provides guidance to ROI staff as needed during assembly of regulatory submissions Draft more complex correspondence Draft ROCs for more complex contacts Prepare ... Assist with technical preparation for FDA meetings, including review of draft questions and supporting documents Assume additional responsibilities as applicable… more
- Piper Companies (Baltimore, MD)
- …science, life science, technology, commercial, professional engineer, PE, design, drafter , HVAC, power systems, mission critical data center, infrastructure, shop ... drawings, compliance, bid document, bids, AE, group leader, supervise, supervisor, accounting, project management, budget, budgeting, project director, project direction, BD, business development, leads, client service, account manager, project proposal,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and/or review manufacturing process transfer plans, protocols, and reports. Design studies, draft protocol, oversee execution and draft reports necessary to ... raw materials and consumables for compatibility with the Manufacturing process. Draft Process Risk Assessments for implementation of process changes. Requirements… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …topics. This role will also define and implement a process to respond to draft policy/guidance proposals. This role will engage with a range of internal and external ... and oversees/coordinates the process to liaise with broader SMEs to evaluate draft HA guidance and coordinate DS' response/comments to these, to help curate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management review.Involve and attend the Global QA relevant meeting and create the draft of presentation, meeting agenda and meeting minutesInvolve and attend the QA ... strategic meeting and create the draft of presentation, meeting agenda and meeting minutes.May be delegated for logistic planning and coordinating the QA Meeting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as needed.Responsibilities- Contract Coordination: Collate exhibits to create contract draft , Review contract documents for completeness and accuracy; Ensure ... compliant routing of contracts for internal approvals and signatures, based on amount and signing authority; Create Purchase request from executed contract; and Update CLM system/trackers throughout the process.- Conduct simple negotiations review contractual… more
- Merck & Co. (Rahway, NJ)
- …of change management, communication, and training plans.Partner with stakeholders to draft and distribute project communications and end user support materials, ... including but not limited to: newsletters, SharePoint sites, user guides, PowerPoint presentations, animated videos, etc.Ensure all work is timely, complete, and compliant with established policies and procedures.Effectively build relationships and collaborate… more
- Merck & Co. (Rahway, NJ)
- …leads the resolution of issues affecting quality and efficiency. -Reviews draft policy and standards.Communicates with senior management within our company and ... the third-party organization as needed. -Facilitates and/or prepares cross-functional management presentations.Education Minimum Requirement: At a minimum the position requires a bachelor's degree in engineering, IT, Biology, Chemistry or related field.… more
- Novo Nordisk Inc. (Boulder, CO)
- …analytical development team into the on-site analytical lab for nonGMP manufacturing Draft work instructions for use in nonGMP analysis Conduct in-process and final ... batch analyses for manufacturing of oligonucleotides Provide analytical support for drug product formulation studies, including osmolality, viscosity, HPLC, UV Conduct stability studies for drug substance and drug product Ability to run a multitude of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …knowledge of regulator and industry trends related to risk management. May draft and/or propose changes to SOPs/SOIs related to risk management. Keeps management ... aware of any gaps in risk management planning, creation, and execution- Lead/Manage RMP initiatives. Lead and/manage RMP initiatives and activities related to risk management planning, risk management sciences, and risk management tools and resources.- Risk… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in the US) for assigned Daiichi Sankyo products. This position ensures that draft labeling complies with all applicable regulations and guidelines and with Company ... Core Data Sheets and manages deviations. This position interacts across the RA function globally and interacts across functional as well as regional areas. This position often works with ambiguity and complex problems, focusing on strategic and operational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …documentation for FDA briefing packages Work with project leader and team to draft FDA meeting requests and supporting briefing packages for FDA meetings (pre-IND, ... EOP 2, pre-NDA, pre-BLA) for review by Project Leaders Write Regulatory documents translating team strategy into regulatory overview documents such as cover letters, pre-meeting package, and other US specific regulatory positioning documents to assist Project… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …and resolving funding, contract and grant issues, the ability to draft , review and approve moderate-to-complex non-routine contractual instruments, and demonstrated ... knowledge of contracting concepts, applicable public acquisition laws and associated regulations.Must have superior professional-level written and verbal communication skills; a high degree of professionalism, diplomacy and discretion; excellent judgment,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to identify mitigations and opportunities to shape legislation, proposed rules, and draft guidance. Research and develop positions on key public policy issues with ... the potential to impact Daiichi Sankyo's business and patients. Collaborate with colleagues across Daiichi Sankyo to promote its overall business, legislative, and policy goals.- Develop materials for use in engagement with external stakeholders (Congress,… more
- The Law Firm of Victoria (Birmingham, MI)
- …6. Conduct thorough legal research, analysis, and case preparation. 7. Draft legal documents, including petitions, motions, agreements, judgments and court ... pleadings. 8. Maintain effective communication with clients, colleagues, and other shareholders. Why Join Us: 1. Join a dynamic and supportive legal team dedicated to achieving positive outcomes for our clients. 2. Competitive compensation package with… more
- Aequor (NJ)
- …development plan and protocol analysis. Reviewing and providing input for draft medical protocols to develop packaging and labelling configurations and create ... packaging specifications in collaboration with Clinical Operations partners. Collaborating with Global Clinical Supply Chain functions and external Vendors on the package design and label development for investigational product to meet all protocol and… more
- Aequor (Tampa, FL)
- …Utilize Knowledgebase to address End User inquiries and create Knowledgebase draft articles to address knowledge gaps. Participate in application testing, upgrades ... and deployment, and internal Service Desk projects as needed. Adhere to all Service Desk processes and procedures. Drive quality, process improvement and innovation to optimize service delivery. **NOTE: Responsibilities of this role are not limited to the… more
- Tris Pharma (Monmouth Junction, NJ)
- …Thin Layer Chromatography (TLC) + Dissolution Apparatus (Distek). Initiate + draft investigations. Create, review + revise SOPs. Assess equip. perf. Execute ... equip. qual. protocols. Train + mentor chemists on instrument oper. + maint. Eval instrument perf. + troubleshoot instrument malfunction. Process + report calibration results using instrument specific data processing software. Complete timely compendial review… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(IT, Finance, HR, and Legal).ResponsibilitiesTraining CommunicationsPlan, create, develop/build, draft and deliver various, innovative training vehicles to inform ... and educate employees on compliance issues through the utilization of existing and novel technological solutions (including LMS, Articulate E-Learning software, and video) in accordance with the approved Compliance Training Plan.Serve as the point for creative… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Develop initial price assumptions and reimbursement access strategy recommendations- Draft and establish price guidance in collaboration with top countries ... and regions, including design of a global launch sequence plan by collaborating cross-functionally- Provide pricing input to key planning processes for Brand planning and portfolio review- Provides input to Clinical on trial design, endpoints and comparators… more
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