Thermo Fisher Scientific

Compliance

• Join the global Regulatory Affairs team in a client-dedicated role supporting commercial medicinal products used in clinical trials, including comparator and auxiliary medicinal products
• Perform EU/EEA regulatory assessments of changes, applying applicable legislation, EU Clinical Trials Regulation requirements and regulatory guidance
• Assess the impact of CMC, manufacturing, supply and labelling changes on clinical trial documentation and determine appropriate regulatory actions
• Prepare and maintain Summary of Changes documentation
• Manage product-specific changes impacting sIMPDs, SmPCs and clinical labels
• Manage non-product-specific changes impacting manufacturing/release site lists, manufacturing licences and GMP certificates
• Review and compare revised SmPCs, clinical labels, manufacturing licences, GMP certificates and related documents
• Provide CMC regulatory expertise and support targeted authoring, updating or expert review of sIMPD and other CMC documentation
• Coordinate regulatory change-control activities, including planning, stakeholder coordination, action follow-up and maintenance of trackers and systems
• Provide regulatory intelligence and practical interpretation of EU/EEA requirements
• Collaborate with Regulatory Affairs, CMC, Labelling, Quality Assurance and Clinical Supplies teams
• Identify issues, propose pragmatic solutions and ensure activities progress within agreed timelines
• Support development and continuous improvement of processes, templates, trackers, decision frameworks and ways of working
• Ensure activities and deliverables meet applicable regulatory, quality and organizational requirements

Regulatory Affairs Manager/Senior Manager – CMC, Regulatory Change Management

General

• Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy
• Provide local regulatory strategy advice to internal clients
• Develop and implement local submission strategy and provide technical expertise and coordination oversight
• Serve as primary contact for investigators and local regulatory authorities
• Ensure guidelines and processes are followed for internal, investigator and regulatory-authority communications
• Act as key country-level contact for submission-related activities
• Participate in submission, review and project team meetings
• Coordinate site start-up activities with internal functional departments and align submission timelines with site activation critical paths
• Achieve company target cycle times for site activations
• Prepare regulatory compliance review packages
• Coordinate local submission activity in accordance with global project submission strategy
• Develop country-specific Patient Information Sheet/Informed Consent documents
• Assist with grant budgets and payment schedule negotiations with sites
• Identify local out-of-scope contract activities and advise relevant functions
• Support feasibility activities
• Maintain accurate and current trial status information in the database
• Oversee country study files and ensure compliance with PPD WPD or client SOPs
• Maintain knowledge of PPD SOPs, client SOPs/directives and current regulatory guidelines
• Direct or mentor SIA individuals assigned to projects
• Identify, resolve or escalate regulatory-process issues and anomalies

Senior Country Approval Specialist

Sales

• Support revenue growth and contribute to serving science
• Develop and maintain strategic customer relationships
• Promote Thermo Fisher Scientific's portfolio of products and services
• Implement sales strategies
• Identify new business opportunities
• Provide customer support to help customers achieve their goals
• Manage assigned territory and strategic accounts
• Represent Thermo Fisher Scientific's scientific solutions

Sales Representative II

Associate

• Demonstrate safe work habits and adhere to safety procedures and guidelines
• Participate in Tier 1 meetings
• Support team preparedness and room preparation activities
• Maintain GMP Kanban supporting manufacturing operations
• Support continuous improvement in process operations and systems
• Support tech transfer activities
• Seek and welcome feedback and respond to coaching
• Spend at least 80–90% of time on the manufacturing floor
• Work closely with related functional areas to achieve production goals and timelines
• Identify and implement efficiency improvements
• Manage inventory supplies
• Perform manufacturing associate duties in a cleanroom and laboratory setting
• Work with hazardous/toxic materials while following GMP, PPE, and safety requirements

Manufacturing Associate II – 1st Shift

• Train customers on Phadia instrumentation, assays, software, and laboratory workflows
• Provide application and technical support remotely and at customer sites
• Troubleshoot customer issues and support resolution of reagent-, assay-, and system-related complaints
• Help customers improve laboratory workflows and implement effective processes
• Support instrument and assay qualification activities when required
• Participate in customer meetings, user groups, training events, and technical presentations
• Work with local and global technical teams to resolve complex customer issues
• Maintain accurate training, complaint, application, and service records in CRM systems
• Maintain and expand knowledge of instruments, assays, software, and diagnostic workflows
• Perform preventive maintenance and planned service activities as service responsibilities develop
• Troubleshoot and repair laboratory instrumentation
• Support instrument installations and commissioning
• Perform software and middleware updates
• Document service activities accurately and on time
• Provide feedback to technical and product teams on instrument performance and customer experience
• Follow applicable quality and regulatory requirements, company procedures, and documentation standards

Field Applications & Service Specialist

• Provide on-site asset management and laboratory support services for key customer accounts
• Serve as the primary point of contact between customers and Thermo Fisher Scientific
• Ensure seamless delivery of services while maintaining high customer satisfaction
• Manage day-to-day operations
• Coordinate service activities
• Contribute to continuous improvement initiatives impacting customers' ability to make the world healthier, cleaner, and safer
• Interact with engineers, suppliers, and internal partners

On Site Service Specialist

Manager

• Manage clinical operational and quality aspects of moderate- to high-complexity studies in compliance with ICH GCP
• Assume Lead CTM, Clinical Study Manager, process improvement, program management, management, or project coordination responsibilities as assigned
• Develop clinical tools, monitoring plans, guidelines, data quality plans, and master action plans
• Ensure timely setup, organization, content, quality, and archiving of Trial Master File documents and study materials
• Participate in development of CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
• Collaborate with project managers to prepare and present client meetings, including bid defense and hand-off meetings
• Lead clinical team meetings and coordinate departments to maintain timelines, resources, interactions, and quality
• Implement and train teams on standardized clinical monitoring processes
• Monitor clinical activity timelines, metrics, project status, recovery actions, monitoring visit reports, CRF collection, query resolution, trial performance, and contractual obligations
• Communicate with study sites regarding protocols, patient participation, case report forms, and study issues
• Coordinate study start-up activities, regulatory submissions, and ethics committee follow-up when applicable
• Provide input into clinical activity forecasts
• Manage clinical resources, delegation, assignment of responsibilities, and additional resource requirements
• Conduct accompanied field visits and manage project financials when applicable
• In assigned North American GPHS projects, undertake limited line management responsibilities when applicable

Senior Non-Interventional Studies Clinical Team Manager

Project Manager

• Liaise with PPD operational departments, affiliates, and sponsors
• Coordinate study setup, maintenance, and closure activities for identified protocols and/or study programs
• Serve as local study coverage for global studies and point of contact for Clinical teams
• Ensure timely completion of study activities and deliverables
• Document communications and actions with sponsors or investigator sites
• Manage existing Batch, Supply Only, and “In Conduct” studies
• Develop new study setups in collaboration with the Tech Ops group
• Provide backup coverage for Project Management staff and Project Managers
• Advise Project Managers on procedural and budgetary items and study modifications or protocol amendments
• Monitor monthly Budget-to-Burn reviews and contract modifications
• Support initial study supply orders, templates, and shipment requests
• Monitor completion of shipment requests
• Schedule internal and external meetings and teleconferences; prepare agendas and distribute minutes
• Monitor assignments, adjust priorities and work schedules, and complete additional project, client, and departmental tasks

Project Manager, I-Labs

• Monitor and manage all aspects of designated clinical trial protocols in Global Central Labs
• Ensure overall project performance and client satisfaction throughout assigned clinical trial lifecycles
• Provide internal consulting on project management issues and identify process and efficiency improvements
• Act as chief liaison with major sponsors and operational personnel
• Manage large study programs
• Prepare and maintain process documents and back up the (Associate) Director PM when needed
• Mentor Project Managers
• Provide oversight and coordination of study initiation
• Review, interpret, translate, and program study protocols into complete and accurate databases
• Coordinate with internal departments and external vendors to ensure project requirements are understood and followed
• Facilitate technical and clinical laboratory information flow among sites, sponsors, and non-technical stakeholders
• Prepare study specification documents and maintain study master files with version control for specifications, budgets, and contracts
• Ensure sponsor authorization and signed approval of current documents and contract completion before service delivery
• Ensure compliance with FDA, Good Clinical Practice, IATA, SOPs, and other biological specimen transport regulations
• Coordinate protocol amendment reviews, budgetary and procedural changes, and issue resolution
• Serve as liaison between sponsors and internal departments throughout study phases
• Educate investigator sites through protocol-specific laboratory procedure presentations and demonstrations
• Manage day-to-day clinical trial activities, resolve issues, and answer queries
• Consult with IT and data management teams on software and functionality design, validation, and implementation
• Support RFP feasibility assessments and draft proposal responses with BD and finance teams
• Guide Project Managers and Set-up Administrators, train junior personnel, identify efficiencies, and author/revise procedural documents

Project Manager – Labs

Sales Development Rep

• Review, prioritize, and qualify inbound and marketing-generated leads
• Contact prospective customers to understand their scientific needs, applications, timelines, and potential opportunities
• Route qualified opportunities to the appropriate field sales representative
• Support field sales teams with prospecting, account development, and customer follow-up within assigned regions
• Follow up on leads from campaigns, webinars, trade shows, and other marketing activities
• Maintain accurate lead and opportunity information in CRM systems
• Develop knowledge of bioproduction products, workflows, customers, and sales processes
• Partner with Sales, Marketing, and technical teams to improve lead conversion and pipeline development
• Track biotech VC funding within the assigned territory and use funding events for prospecting and account development
• Develop customer engagement, lead qualification, opportunity management, and consultative selling skills

Sales Development Associate

QA Engineer

• Execute full localization QA test cycles across different platforms, OS versions, and testing environments, including production
• Review, verify, edit, score, and translate copy across a wide range of media and content types
• Validate localized content for tone, grammar, context, cultural relevance, and linguistic correctness
• Evaluate UI behavior for truncation, clipping, alignment, wrapping, and encoding issues
• Report and track bugs clearly and accurately; retest to confirm fixes
• Provide clear feedback and suggestions regarding linguistic errors, UX issues, and functional defects
• Contribute updates and recommendations to Style Guides and Terminology Databases
• Assist with ad-hoc localization QA tasks, spot checks, and build verifications
• Collaborate with localization PMs, translators, developers, and QA teams
• Suggest process or workflow improvements to increase QA efficiency, scalability, and consistency

Localization QA Tester, Indonesian

Medical Director

• Provide medical oversight of clinical trials to ensure SOPs, client directives, GCP and regulatory requirements are followed
• Attend and present at investigator and sponsor meetings
• Provide medical consultation to clients, investigators and project team members
• Support business development activities
• Provide medical review and analysis of serious adverse events, marketed-product ICSR and periodic safety reports
• Manage medical aspects of contracted tasks across the pharmaceutical product life-cycle
• Ensure pharmacovigilance tasks are properly executed and comply with regulations, ICH guidelines, client SOPs and project procedures
• Answer study-related medical questions and maintain communication with associates and clients
• Provide therapeutic and protocol training
• Write or review CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules and related deliverables
• Monitor safety variables in clinical studies, including adverse events, laboratory abnormalities, medical-status changes, concomitant medications and unblinding requests
• Discuss medical concerns with principal investigators and clients and make clinical decisions relating to investigational studies
• Review adverse events of special interest, serious adverse events and clinical outcomes reported by study sites
• Perform contracted data review and assess potential safety concerns
• Manage signal detection, review aggregate reports, contribute to label updates and support dossier maintenance and risk management
• Medically review adverse-event and serious-adverse-event data from solicited, spontaneous and literature sources

Senior Medical Director – Endocrinology

Procurement

• Support procurement and financial processes related to clinical supplies vendors
• Create and manage purchase requisitions and purchase orders
• Monitor purchase-order lifecycle and resolve discrepancies
• Perform receipt and validation of vendor invoices
• Support invoice reconciliation
• Support vendor management through accurate financial tracking and invoice-issues reporting
• Identify operational inefficiencies and suggest improvements
• Ensure compliance with procurement and financial procedures
• Collaborate with cross-functional teams to resolve procurement-related issues

Procurement Assistant

Safety Specialist

• Regularly monitor and manage GPS mailboxes
• Communicate with safety vendors regarding individual case safety reports and aggregate reports/listings
• Manage reviews of ICSRs, listings, tables, and figures for completeness and quality
• Manage serious adverse event reconciliation across post-marketing and clinical trial databases and listings
• Collaborate with clinical, medical, regulatory, healthcare professional, consumer, and contracted-resource stakeholders to obtain safety information
• Participate in meetings and take minutes as required
• Support generation of aggregate safety reports
• Communicate with business partners and distributors regarding receipt and transmission of safety information under applicable data exchange agreements
• Attend GPS operational meetings and contribute as a subject matter expert
• Identify issues and improvement areas and escalate appropriately
• Contribute to developing new processes and procedures
• Support implementation of new processes and systems
• Perform activities in compliance with client controlled procedures and applicable global and local regulations
• Perform other tasks assigned by the line manager or Head of GPS

Senior Safety Specialist

Technician

• Clean, inspect, and detail the pre-repair condition of repairs
• Perform system and component failure analysis using validated diagnostic troubleshooting techniques
• Replace non-conforming and preventive maintenance parts as needed
• Test and calibrate completed repairs
• Provide comprehensive test data, documentation, and service reporting
• Handle record keeping for Return Authorizations, Service Quotes, and Service Orders
• Drive lean practices and continuous improvement events within the service business