Philippines · Remote Solely
Work Schedule Third Shift (Nights) Environmental Conditions Office Job Description Join Us as a Safety Committee Specialist – Make an Impact at the Forefront of Innovation At Thermo Fisher Scientific, you’ll discover mea…
Skills: Clinical Endpoint Committees, Adjudication, Study Start-up, Dossier Compilation, Critical Thinking
Zaventem, Flanders, Belgium · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Descriptio…
Skills: Executive Leadership, Organizational Development, Coaching and Mentoring, Operational Excellence, Lean Methodologies
Hyderabad, Telangana, India · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: C#, .NET, WPF, Object-Oriented Programming, SOLID Principles
Ulloa, Costa Rica · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join us as Senior Safety Committee Specialist – To lead complex safety projects, collaborate with global teams, and ensure the successful i…
Skills: CEC/DSMB Study Start-up, Pharmacovigilance, Clinical Adjudication, Charter Development, Dossier Compilation
São Paulo, São Paulo, Brazil · Remote Solely
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Medical Writer - Make an Impact at the Forefront of Innovation The Senior Medical Writer provides high-quality medical …
Skills: Project Management, Budgeting, Forecasting, Resource Management, Medical Writing
Chicago, Illinois, United States · Remote OK
$83k–$111k/yr
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Are you an experienced and technical laboratory sales professional who enjoys helping customers achieve their clinical, operational and fin…
Skills: Healthcare Sales, Capital Equipment Sales, Clinical Diagnostics, Salesforce, CRM Tools
Sofia, Sofia-City, Bulgaria · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringin…
Skills: Employee Expense Management, Corporate Credit Card Administration, Financial Auditing, ERP Systems, Microsoft Excel
Middleton, Wisconsin, United States · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glas…
Skills: GMP, Line Management, Technical Writing, Root Cause Analysis, Project Management
Grand Island, New York, United States · On-site
$87k–$116k/yr
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Bioinformatics, Knowledgebase Management, Python, Metabolic Pathway Analysis, Knowledge Extraction
Greenville, North Carolina, United States · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work…
Skills: Strategic Leadership, Operational Excellence, cGMP Compliance, Pharmaceutical Manufacturing, Packaging Operations
Grand Island, New York, United States · On-site
$87k–$116k/yr
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Bioinformatics, Machine Learning, Metabolic Flux Analysis, Multi-omics Integration, Python
Ciudad de México, Mexico · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Full-cycle Recruitment, Sourcing Strategies, Boolean Search, Stakeholder Management, Competency-based Interviewing
High Point, North Carolina, United States · On-site
Work Schedule 12 hr shift/days Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail po…
Skills: Machine Operation, GMP Adherence, BPR Documentation, SOP Compliance, Material Handling
Sofia, Sofia-City, Bulgaria · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colle…
Skills: Financial Analysis, Budgeting, Forecasting, Variance Analysis, Microsoft Excel
Ulloa, Costa Rica · Hybrid
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description About Thermo Fisher Scientific: When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive …
Skills: eSourcing, Procurement, RFx, eAuctions, Data Analysis
Paisley, Scotland, United Kingdom · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Sales Strategy, Commercial Leadership, Bioproduction, Bioprocessing, Pipeline Management
Florence, South Carolina, United States · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Pr…
Skills: Synthetic Organic Chemistry, Process Development, HPLC, GC, LC/MS
Peabody, Massachusetts, United States · On-site
$18/hr–$27/hr
Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Warehouse, Will work with hazardous/toxic materials Job Description As part of the Thermo Fisher Scientific team, you’ll …
Skills: Order Picking, Inventory Management, Forklift Operation, cGMP Compliance, RF Scanning
Bengaluru, Karnataka, India · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Python, Machine Learning, TensorFlow, PyTorch, Scikit-learn
Bengaluru, Karnataka, India · Remote OK
Work Schedule Other Environmental Conditions Office Job Description Summarized Purpose: We are offering an outstanding opportunity to join Thermo Fisher Scientific as a Engineer II, Software Quality Assurance. In this ro…
Skills: Manual Testing, Defect Tracking, SQL, Communication, Problem-solving
Philippines • Remote Solely
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The specialist manages day-to-day activities for Clinical Endpoint Committees, including study start-up, charter development, and dossier submission. They collaborate with project teams and external vendors to ensure quality and accuracy in a highly regulated environment.
Requires a bachelor's degree or equivalent with at least 2 years of relevant experience. Candidates must possess a general understanding of pathophysiology and proficiency in Microsoft Office and database management.
Join Us as a Safety Committee Specialist – Make an Impact at the Forefront of Innovation
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
The Safety Committee Specialist performs moderate day-to-day committee activities for Clinical Endpoint Committees (CEC) within a highly regulated environment. Displays a working knowledge of the procedures and electronic platforms/ software systems utilized for direct communications with the CEC committees and other external and pre-existing software systems. Effectively collaborates with various parties such as project team members, data management, biostatistics, client contacts, investigators, committee members, and third-party vendors.
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
What You'll Do:
• Initiate CEC study start-up activities (charter development, member
contracting, electronic adjudication system build).
• Complete CEC/DSMB close-out activities.
• Perform day-to-day CEC activities through expert knowledge of
specialty committee processes and procedures.
• Review adjudication publications and information sources to keep
updated on current regulations, practices, procedures and proposals related to
changes in CEC practices.
• Maintain medical understanding of applicable therapeutic area and disease
states.
• Prepare and QCs CEC dossier compilation and submission.
• Assist with routine project implementation and coordination, including
presentations at client/investigator meetings, and review of metrics and budget
considerations as they relate to specialty committee activities.
• May assist in the preparation of departmental and project-specific procedures
and processes, prepare for and attend audits, kick-off and investigator meetings
representing the CEC specialty committee functions
Education and Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
In some cases, an equivalency, consisting of a combination of appropriate education, training
and/or directly related experience, will be considered sufficient for an individual to meet the
requirements of the role.
Knowledge, Skills, Abilities:
• General understanding of pathophysiology and the disease process
• Detailed knowledge of relevant therapeutic areas as required for CEC and/or DSMB review
• Strong critical thinking and problem-solving skills
• Good oral and written communication skills including paraphrasing skills
• Good command of English and ability to translate information into local language where required
• Computer literate with the ability to work within multiple databases
• Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)
• Understanding the importance of and compliance with procedural documents and regulations
• Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
• Strong attention to detail
• Ability to maintain a positive and professional demeanor in challenging circumstances
• Ability to work effectively within a team to attain a shared goal
• Able to operate in a lead capacity
Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.
Why join us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
