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  • Technical Writer  

    - Marin County
    Industry: PharmaceuticalsTitle: Technical Writer - CMCJob ID: 36462679... Read More
    Industry: PharmaceuticalsTitle: Technical Writer - CMCJob ID: 36462679Location: San Rafael, CA (Hybrid)Duration: 06+ months contract (+Possibility of extension)Details:Author CMC content, initiate reviews, lead comment adjudication/finalization to deliver a health authority submission-ready dossier(s).Excellent written and verbal communication skills.Ability to understand and interpret complex scientific informationSkills:Excellent written and verbal communication skills.Ability to understand and interpret complex scientific information

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  • Manufacturing Contractor I  

    - Bristol County
    Industry: PharmaceuticalsTitle: Manufacturing Contractor IJob ID: NORT... Read More
    Industry: PharmaceuticalsTitle: Manufacturing Contractor IJob ID: NORT000013Location: Norton, MADuration: 12+ months contract (+Possibility of extension)Shift: 4x10 Weds-Sat 6am-4pmOverview:With direct supervision, this individual will perform routine clinical manufacturing operations at the Norton Manufacturing Facility, ensuring safe, efficient, and cGMP-compliant operations at all times. Responsibilities include, but are not limited to, operation of production equipment in the areas of weigh/dispense, solution preparation, equipment CIP/COP and small parts cleaning, and materials stocking in manufacturing suites. Operates production equipment according to SOPs for the production of clinical products. Requires interaction with support groups (Facilities, QC, QA, Materials Management, EHS) to ensure accurate completion of activities.Top 3 Must-Have Skills / Experience:Strong communication skills – able to retain and apply information effectively.Troubleshooting skills – should be able to speak to specific examples.Team player – works well in a collaborative, fast-paced environment.Nice-to-Have Skills / Experience:Experience with TFF or UFF operationsFamiliarity with HPLC systemsTools / Technologies:DeltaVBasic automation experience preferredSoft Skills / Cultural Fit:Outgoing and communicative – fits into an outspoken team environmentProactive, self-motivated, and eager to learnComfortable working with diverse personalities Read Less
  • Safety Specialist  

    - East Baton Rouge Parish
    Safety Specialist - Safety Specialist Baton Rouge LA Duration :3+ Mont... Read More
    Safety Specialist - Safety Specialist Baton Rouge LA Duration :3+ Months SERVICES TO BE PERFORMED · Identify and inform management of compliance issues, risks, and improvement opportunities through the conduct of , weekly, and monthly audits · Facilitate investigation process · Maintain required paperwork to comply with Amazon and regulations · Enter Information in internal database in a timely manner · Perform observations & audits · Train and assist others (Area Managers, team members, etc.) to complete their responsibilities (Audits, Follow Rules, etc.) · Perform specific training as required by the Manager · May have additional responsibility for fire prevention, hazardous waste management, or other related activities depending on the business unit and location · Participate in process improvement activities and manage actions to completion Essential Skills, Knowledge and Experience: · Ability to communicate and needs to all levels of the organization · Calm demeanor in situations REQUIRED SKILLS Minimum of 1 years in an Environmental & (EHS) related field or bachelor's degree in related field Knowledge of OSHA regulations specifically 29 CFR 1910 Experience using Microsoft Word and Excel in a professional capacity · Experience maintaining confidentiality in matters involving security and/or personnel issues in the work place Available to work flexible shifts including days, nights and/or weekends PREFERRED SKILLS Bachelor's degree or higher, preferably in a related field Strong communication, teamwork, analysis, judgment, and customer focus skills Experience leading and managing a team Ability to analyze accident data, new processes, and machinery for potential concerns and conduct job hazard and job analyses Experienced in response and currently holds and certificates Experience in Worker's case management Passion for safety Experience in healthcare or industrial settings Experience with OSHA regulations Experience with Workers Compensation

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  • Industry: PharmaceuticalsTitle: Senior Clinical Supply Chain PlannerJo... Read More
    Industry: PharmaceuticalsTitle: Senior Clinical Supply Chain PlannerJob ID: CAMB000067Location: Cambridge, MA (Hybrid)Duration: 06+ months contract (+Possibility of extension)Hybrid: Starting will be 3 days onsite Tues-Thurs ; once they are up to speed can be Tues and Weds.Job OverviewThe Clinical Supply Chain Planner is responsible for the management and oversight of end to end clinical supply chain activity for assigned clinical protocols. This position works closely with key stake holders including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure seamless supply of Clinical Trial Material. Some key areas of management/oversight include forecasting, packaging, labeling, distribution, inventory management, financial planning/ budgeting, vendor oversight, and eTMF filing of Clinical Supply documents. A successful candidate will be skilled at understanding the Clinical Supply needs and responsibilities, exhibit strong attention to detail, support a collaborative environment with a strong communication skillset, and the ability to prioritize workload and meet project timelines.Summary of Key Responsibilities• Managing packaging, labeling, and distribution of clinical trial material for global clinical trials• Support (Interactive Response Technology) IRT development, user acceptance testing (UAT), and system oversight, as well as utilize the system to actively manage clinical trial material.• Utilize and support the management and use of home-grown budget forecasting and planning tool• Partner with Clinical Operations to align on demand assumptions• Develop supply strategies to maximize supply efficiency and minimize waste• Design and actively manage supply & demand forecasts in our web-based optimization tool• Identify potential supply risks, and develop risk mitigation plans as necessary• Drive label creation and approval process, including translations and regulatory requirements• Communicate clinical supply requirements to Global Planning and ensure seamless coordination of demand and supply• Support return and destruction of clinical trial material for assigned protocols• Manage program and/or protocol budget, monitor Key Performance Indicators (KPIs), and strive to achieve relevant cost saving targets• Maintain collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirementsQualifications• BS degree in Life Sciences or Supply Chain Management• Experience: Minimum 3+ years of experience in clinical supply• Understanding of end to end clinical supply chain activity• Experience with supply/demand forecasting systems a plus (eg. NSIDE, Bioclinica, 4G, Oracle, etc)• Experience with IRT systems• Strong understanding of GxP• Proficient knowledge of MS Office (Excel, PowerPoint, Visio, Project, etc)• Demonstrated flexibility to adapt to external environment influences through identifying new strategies and tactics• Strong attention to detail• Excellent communication, collaboration, and influencing skills• Ability to multi-task and manage complex challengesAdditional Informations:Manager is seeking someone with min 3 years experience in clinical supply. Please target candidates with 3-7 years of experience. Not looking for someone who is sr manager or manager level.Ideal experience:Supply Demand forecastingIRT / UAT exp. and set upWorking cross-functionally and Internal/Externally with clin ops or stability teams or CMOsWorking with labels (IE: Experiences with booklets, global studies, translations, packaging, production requests )Can work independently and hit the ground runningHigh PerformerHybrid: Starting will be 3 days onsite Tues-Thurs ; once they are up to speed can be Tues and Weds. Read Less
  • Administrative Assistant  

    - Marion County
    Industry: Pharma DevicesJob Title: Administrative Assistant IIIJob ID:... Read More
    Industry: Pharma DevicesJob Title: Administrative Assistant IIIJob ID: ROCGJP00037649Location: Indianapolis, INDuration: 12+ months contract (+Possibility of extension)1st Shift Hours8am - 5pm Mon - Fri100% onsiteCommit to 36 month contractOverview:We are a business transformation program that aims to deliver best-in-suite, user-centric digital solutions fthat will help manage our company as efficiently as possible. At the center of ASPIRE is the One Enterprise, the future of our current enterprise landscape. ASPIRE is co-creating one harmonized process house across the enterprise, with SAP S/4HANA at its core - a technology that will replace existing and soon outdated SAP local and regional systems. By following a template approach within SAP, available to all entities around the globe, our core business processes will become more integrated, simplified, harmonized, and scalable.We are looking for a Strategic Administrative Partner for the deployment of ASPIRE to support the Wave Lead across all US Sites (Waves 5a & 5b: Indianapolis, Branchburg, Tucson, Carlsbad, Santa Clara, & Pleasanton). This role will be part of each Wave Lead Team to ensure the right level of support is provided and aligned to, as necessary, across Waves. As a Strategic Administrative Partner for ASPIRE, you are responsible for supporting the Wave Lead in operational excellence by focusing on team development, change management, logistics and scheduling, planning and communication. This role is unique in that it serves to support leadership teams in ensuring that they are collectively focused on the betterment of the entire organization. This individual will lead and collaborate as a strong architect who is ready to stimulate and foster an environment of innovation and support the operational activities of the organization by promoting and developing a strong connectivity to the broader ASPIRE Project.The OpportunityAdministrative Support for the Wave Lead: You provide comprehensive, proactive and professional assistance, leadership and guidance for organizational activities for the Wave Lead and as applicable, Lead Team members. You assist with administrative activities such as travel, expenses, meetings, and calendars. As requested, you drive leadership meetings and plan the agenda and support the team in timely, well-informed decision making.You provide guidance, operationalize and monitor the execution of work, constantly connecting our delivery organization. This includes ensuring any additional templates and documentation management, are in place to support the Wave Lead. You support activities for the wave and functional teams to meet established milestones.You prepare, and execute a wrap-up of meetings with internal and external stakeholders (agenda, documentation, tracking of action items), independent event management for the manager / team (e.g. events, internal and external workshops, etc.)Project management: You actively collaborate in organizational and group projects, as project lead / project member. This includes project conception and implementation as well as monitoring of the results. Including:Executing the Change Control Process for the respective areas of responsibilityDriving reporting activities and provide accurate status updates and reportingAccountable for implementation & management of Status & Progress ReportingProject Templates and Documentation ManagementStrategic support: You pick up on current strategically important topics and implement them in your own area of responsibility.You actively contribute, drive and implement ASPIRE goals / vision / strategy. You independently carry impulses into the management group (e.g. tools, working methods). You support projects, as identified, to support the successful delivery of the programYou are a mood barometer from the manager to the area and from the area to the manager to create understanding for each other, promote cooperation and increase LT effectiveness and cohesiveness.Who You AreYou hold an Associate or Bachelor's Degree degree in related fields. Bachelor's degree preferred.5-7 years' experience in an Assistant role, or comparable activityYou have experience with project management approaches, tools and phases of the project lifecycle; including agile.You possess strong knowledge and experience using Google Suite.You have experience dealing with collaboration tools and working in virtual teams. This includes demonstrated ability to successfully organize, coordinate, and integrate multiple streams of information and activities.Knowledge, Skills & AttributesYou possess problem-solving skills with the ability to exercise mature judgment. This includes the ability to handle highly confidential and critical information.You have strong interpersonal and communication skills with a demonstrated ability to work within the Waves, as well as, DIA Ops & Megasites Cluster leadership.You have excellent written and verbal communication skills and are fluent in English language, both written and spokenYou are detail-oriented with excellent organizational and process management skills with the ability to learn quickly with a high tolerance for ambiguity and complexity.You have the ability to cultivate a strong and trusting relationship with executive leadersYou have excellent time management and organizational skills, with an ability to consistently execute multiple, and sometimes competing activities to a high quality and timely conclusion,You are willing to stretch beyond your comfort zone to learn new skills in a rapidly changing environment and have the ability to build and maintain business relationships.LocationsYou are local to Indianapolis. Relocation benefits are not available for this position.*Please note that this position will require business travel 4-6x per year. This role will work across multiple international time zones. Read Less
  • Study Manager  

    - Marin County
    Industry: Pharmaceuticals Title: Sr. Study Specialist, Global Study Op... Read More
    Industry: Pharmaceuticals Title: Sr. Study Specialist, Global Study OperationsJob ID: 36428598Location: San Rafael CA (Hybrid)Duration: 12+ months contract (+Possibility of extension)Job DescriptionClient is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. Client aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative Client therapeutics, advancing the standard of care, and providing personalized support and services globally.The Client Global Study Operations function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.Role SummaryThe Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). This may include contributing to and/or supporting study related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The Sr. SS will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s). Within the role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following competencies:Core Competencies:Agility and ProactivityLeadershipCommunication and CollaborationTechnical Competencies:Study Management and ExecutionCompliance and QualityDrug Development and Study DesignProduct and Therapeutic Area KnowledgeResponsibilities include but are not limited to:Develop study specific documentation, as delegated by the Study ManagerContribute to the oversight of country and site feasibility assessment and site selection.Oversight of CRO for IRB/EC related submission/approval activitiesOversight of essential documents for study life-cycle managementDevelop/Oversee site and investigator training materialsPresent at investigator meetings as assignedEnsure accurate and timely study entry and updates to ClinicalTrials.govFacilitate Screening Authorization Forms sign off and oversee tracking, where applicableProcess documents for signature in DocuSignOversight of Clinical Trial InsuranceAttend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.Oversee and manage essential documents in the Trial Master File (TMF)Contribute to Global Study Operations risks identification and mitigations.Provide support and administrative assistance with internal and external meetingsSkills:Experience in a biotechnology or pharmaceutical company, oversight of external vendors including SOW, budgets, POs, and invoice management (e.g., CROs, central labs, imaging etc.).Education:BA/BS or higher in nursing, life or health sciences is preferred. Industry or relevant experience in lieu of education is considered. Read Less
  • Associate Scientist  

    - Middlesex County
    Industry: PharmaceuticalsTitle: Associate Scientist IIJob ID: CAMB0000... Read More
    Industry: PharmaceuticalsTitle: Associate Scientist IIJob ID: CAMB000068Location: Cambridge, MADuration: 06+ months contract (+Possibility of extension)OverviewThe Research Department at Client is seeking a motivated research associate to join our team to support the biology group in research including CNS and emerging tissues. We are seeking a highly organized individual that can work quickly and efficiently in a fast-paced laboratory setting. This ideal candidate will be a strong team player, capable of coordinating tasks with various stakeholders to meet deadlines. This is a full-time, onsite role based in Cambridge MA location, with a requirement to be onsite five days per week.Summary of Key ResponsibilitiesContribute to the design and execution of studies to characterize molecules for RNAi therapeutic programs, including rodent disease models.Support animal tissue processing protocols through grinding, homogenization, RNA extraction, and more.Conduct assays such as qPCR, western blot, ELISA, that support in vivo studies.Analyze and report scientific data to manager.Diligently follow SOPs/protocols.Track samples in databases including but not limited to Electronic Laboratory Notebook (ELN), Laboratory Information Management System (LIMS), Smart Refrigeration systems, Smartsheet's and other proprietary databases.Adapt quickly to changing priorities in a dynamic work environment.Communicate openly and directly with lab groups to provide sufficient solutions that will work for all team members.QualificationsMinimum B.S. degree in a life sciences-related discipline such as Molecular Biology, Cell Biology, or GeneticsMust be flexible, open to new tasks and challenges and able to work on tight deadlines.Exceptional interpersonal skills and the ability to function at a high capacity within a fast-paced team environment.Excellent attention to detail, organizational skills, eagerness to learn, and the ability to follow written and verbal instruction.Working knowledge of standard Microsoft Office applications including Excel, GraphPAD, Outlook, PowerPoint, and Word.Familiarity with laboratory automation and liquid handling systems is a plus. Read Less
  • Medical Affairs Specialist  

    - Orange County
    Position: Medical Affairs Analyst, Req#: 13798-1Location: Irvine, CA (... Read More
    Position: Medical Affairs Analyst, Req#: 13798-1Location: Irvine, CA (100% Onsite), 8:00 AM PST to 5:00 PM PSTDuration: 12+ Month Contract (Possibilities of extension)Job Description:This is a unique opportunity to play an important role in the growing Transcatheter Mitral & Tricuspid Therapies (TMTT) Medical Affairs team, providing innovative solutions to transform treatment for patients suffering from mitral and tricuspid heart disease. This position within Medical Affairs (Contracts & Payments) will support the management and execution of contracts, budget and payments of educational and research grants, HCPs, educators, vendors, contractors, and consultants.This role is a key position with the TMTT business unit. Candidates can expect to interact with and assist high-level healthcare professionals in this role. This team works closely with physician conference preparation, educational grants, and invoicing. The team is open to candidates below 2 years of experience if they fit other requirements. Education and Experience: Bachelor's Degree or equivalentExperience working in healthcare and/or professional environment preferred2+ years of experience requiredProven expertise in Microsoft Office Suite, particularly Excel, PowerPoint, and WordSoft skills are a huge part of this role as this worker will be interacting with internal and external teams daily.Job Responsibilities:Support contract lifecycle including negotiation, initiation, approval, payments, and documentationAssess needs for contract amendments and renewals, provide guidance to stakeholders, make recommendations, and negotiate changes to terms and conditions while mitigating risks to the companySubject matter expert for contracts, intent, and terms of agreementManage educational and sponsorship grants paymentsManage contracts and payments for research grants (investigator-initiated studies)Manage and administer Grant Portal via Salesforce.com (SFDC)Manage educational grant repository and payment tracking systemTrack expenditure versus budget, support forecasting and generate metrics for reportingIdentify and manage process improvement opportunitiesIdentify and resolve problems through collaboration and alignmentPartner with Legal, Compliance, Finance, and other cross-functional groups to ensure appropriate business practicesEnsure strict compliance with processes and activities, and adherence to the industry code of ethicsProfessional and customer-oriented interface with healthcare professionals and other entitiesOther duties as requested

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  • UX Design Producer  

    - Santa Clara County
    Position: Contract UX Design Producer - Retail AppsLocation: Cupertino... Read More
    Position: Contract UX Design Producer - Retail AppsLocation: Cupertino CAInterview Mode: VideoDuration: 7+ months Summary Apple Retail is seeking an exceptional UX Design Producer for a 6-9 month contract to drive the end-to-end design process for a key initiative empowering our global retail teams. This role is pivotal in providing critical project leadership to ensure our internal-facing products are crafted with the same level of care and excellence as our external ones. Description As a Contract UX Design Producer, you will provide immediate operational help for the design team, blending strategic thinking with tactical execution. You will oversee the design lifecycle for a large, complex workstream, from initial concepting through to final engineering delivery. The ideal candidate is an expert at navigating ambiguity and can integrate quickly into a deeply collaborative, fast-paced environment. You are a passionate advocate for human-centered design and have a proven ability to deliver results. Key QualificationsProven ability to lead complex, cross-functional projects, ensuring the delivery of high-quality design solutions in a dynamic environment.Expertise in navigating ambiguity, with a talent for creating structure, clarity, and actionable plans from high-level, abstract ideas.Exceptional communication and presentation skills, with the ability to articulate design decisions, complex problems, and project status clearly and concisely to audiences at all levels.Meticulous attention to detail and effortless organizational skills, with the ability to manage multiple workstreams, schedules, and deliverables simultaneously.A consistent record of shipping successful, high-quality digital products.DescriptionDrive the project lifecycle for the design team, ensuring all activities are prioritized, planned, and executed seamlessly from concept to final implementation.Establish and maintain project plans, work-back schedules, and key documentation, serving as the central source of truth for your projects.Proactively identify, assess, and mitigate risks, dependencies, and constraints, clearing roadblocks to keep the team moving forward.Serve as the central point of contact between the design team and its cross-functional partners, ensuring clear communication and alignment at every stage.Coordinate and facilitate meticulous design handoffs to engineering, ensuring deliverables are complete, clear, and meet all requirements

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