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Principal Medical Writer (Regulatory MW) at THERMO FISHER BIOPHARMA SERVICES PTE LTD
, Ohio, United States - Full Time
Skills Needed
Medical Writing, Project Management, Interpersonal Skills, Problem Solving, Negotiation, Data Interpretation, Regulatory Requirements, Editing, Proofreading, Communication Skills, Presentation Skills, Document Management Systems, Software Development, Clinical Research, Therapeutic Areas, Mentorship
Specialization
A bachelor's degree in a scientific discipline is required, with an advanced degree preferred. Candidates should have at least 8 years of experience in regulatory medical writing and knowledge of global document development guidelines.
Experience Required
Minimum 10 year(s)
Biotech Portfolio Lead, Sr. Director - US, West Coast Region at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Bothell, Washington, United States - Full Time
Skills Needed
Strategic Direction, Business Development, Project Management, Financial Analysis, Interpersonal Skills, Regulatory Guidelines, Marketing Skills, Negotiation Skills, Resource Management, Process Enhancement, Coaching, Consultancy, Operational Performance, Client Relationship Management, Cultural Awareness
Specialization
Candidates must have 15+ years of relevant experience and demonstrate strong financial analysis and interpersonal skills. A Bachelor's degree is preferred, but equivalent experience is accepted.
Experience Required
Minimum 10 year(s)
Senior Order Support Specialist - Dutch Speaking at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Budapest, Budapest, Hungary - Full Time
Skills Needed
Customer Service, Order Management, Problem Solving, Attention To Detail, Communication Skills, Organizational Skills, Self Motivation, Team Player, Judgment, Diplomacy, Microsoft Office, Multitasking, Data Accuracy, Proactive Mindset, Erp Systems, Training Development
Specialization
A minimum of 2-3 years of customer service experience is required, preferably in an SSC or multinational environment. Candidates should possess a high school diploma, with a bachelor's degree preferred but not essential.
Experience Required
Minimum 2 year(s)
Director, Customer Care at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Bengaluru, karnataka, India - Full Time
Skills Needed
Customer Care, Leadership, Team Management, Customer Engagement, Operational Efficiency, Change Management, Revenue Opportunities, Performance Standards, Business Processes, Market Trends, Technology Solutions, Continuous Improvement, Safety, Communication, Budget Management, Emergency Plans
Specialization
Candidates must have a bachelor's degree or equivalent experience and proven experience in leading customer service organizations at a senior management level. Extensive background in nurturing leadership skills and managing large teams is essential.
Experience Required
Minimum 10 year(s)
Technician at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Stone, England, United Kingdom - Full Time
Skills Needed
Laboratory Experience, Attention To Detail, Organizational Skills, Written Communication, Verbal Communication, Teamwork, Problem Solving, Gmp Compliance, Equipment Maintenance, Inventory Management, Documentation, Safety Policies, Training, Sops, Production Troubleshooting, Process Improvements
Specialization
Previous laboratory experience is preferred but not essential, along with familiarity with laboratory equipment and procedures. Strong attention to detail, organizational skills, and the ability to follow instructions are crucial for this role.
Account Manager (m/w/d) Life sciences research consumables and instruments at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Berlin, Guerrero, Germany - Full Time
Skills Needed
Sales, Customer Relationships, Account Planning, Collaboration, Time Management, Analytical Skills, Business Planning, Digital Literacy, Flexibility, Self Motivation, Communication, Life Sciences Knowledge, Team Contribution, Customer Experience, Product Knowledge, Language Proficiency
Specialization
Candidates should have a master's degree or equivalent experience, preferably in a biology or life science field, along with experience in sales within the Life Sciences market. Strong analytical, time-management, and communication skills are essential, along with proficiency in English and German.
Experience Required
Minimum 2 year(s)
Senior Quality Engineer at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Singapore, , Singapore - Full Time
Skills Needed
Quality Assurance, Data Analysis, Process Improvement, Audits, Compliance, Change Management, Statistical Controls, Communication, Interpersonal Skills, Internal Auditor, Lead Auditor, Risk Management, Sop Construction, Corrective Actions, Preventive Actions, Quality Management System
Specialization
A bachelor's degree in Science, Engineering, or equivalent is required, along with a minimum of 5 years of experience in a QA function, preferably in a medical devices or ISO 13485 environment. Candidates should possess strong communication skills and a proactive attitude.
Experience Required
Minimum 5 year(s)
Manufacturing Planner/Scheduler II at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Ferentino, Lazio, Italy - Full Time
Skills Needed
Manufacturing Planning, Scheduling, Analytical Skills, Problem Solving, Organizational Skills, Attention To Detail, Project Management, Communication Skills, Collaboration Skills, Inclusivity, Teamwork, Manufacturing Software Proficiency, Data Analysis, Excel Skills, Sap Proficiency, Materials Management, Production Planning
Specialization
Proven experience in manufacturing planning and scheduling is required, along with strong analytical and problem-solving skills. Candidates should have a bachelor's or master's degree in relevant fields and at least 2-4 years of experience in a production planning/scheduling role.
Experience Required
Minimum 2 year(s)
Technical Writer (User Documentation) at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Vilnius, Vilnius County, Lithuania - Full Time
Skills Needed
Technical Writing, User Documentation, Project Management, Collaboration, Dita Standards, Xml Authoring, Html, Css, Attention To Detail, Interpersonal Skills, Scientific Knowledge, Content Management, Agile Methodologies, Content Organization, Critical Thinking, Process Guidelines
Specialization
A bachelor's degree in science is required, with an advanced degree preferred. Candidates should have writing experience in a scientific environment and familiarity with DITA and XML authoring tools.
Experience Required
Minimum 2 year(s)
Sr Sales Support Coordinator at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Town of Grand Island, New York, United States - Full Time
Skills Needed
Customer Service, Order Entry, Salesforce, Erp Systems, Microsoft Office Suite, Attention To Detail, Communication Skills, Multitasking, Self Motivation, Team Oriented, Confidentiality, Sound Judgment, Inventory Management, Shipping Processes, Accounting Terminology
Specialization
A high school diploma or equivalent is required, with a preference for a bachelor's degree in business administration or a scientific field. Candidates should have at least 1 year of related customer service experience and proficiency with Salesforce and ERP systems.
Clinical Quality Study Lead at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Inscuinatoyac, Guerrero, Mexico - Full Time
Skills Needed
Clinical Quality Oversight, Gcp Compliance, Quality Principles, Risk Management, Fda Regulations, Eu Regulations, Ich Guidelines, Stakeholder Engagement, Audit Coordination, Inspection Readiness, Clinical Development, Quality Insights, Team Collaboration, Process Improvement, Motivation, Education
Specialization
Candidates should have in-depth knowledge of clinical trial regulations and Good Clinical Practices (GCP). The role requires the ability to motivate and educate study teams on clinical quality aspects and build effective relationships with stakeholders.
Experience Required
Minimum 5 year(s)
Localization Engineer, EMEA at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Madrid, Matruh, Egypt - Full Time
Skills Needed
Json, Resx, Vtt, Html, Xml, Madcap Flare, Dita, Articulate, Mp4, Captivate, Cat Tool, Content Management Systems, Localization Engineering, Programming Languages, Process Automation, Troubleshooting
Specialization
Candidates should have experience with various file formats and localization tools, as well as programming knowledge. A bachelor's degree and approximately 5 years of relevant experience are required.
Experience Required
Minimum 5 year(s)
Senior Material Handler at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Allschwil, Basel-Landschaft, Switzerland - Full Time
Skills Needed
Material Handling, Gmp Compliance, Team Coordination, Inventory Management, Labeling, Quality Assurance, Process Improvement, Self Management, Flexibility, Computer Skills, Ms Office, Initiative, Communication, German Language, English Language, Pharmaceutical Industry
Specialization
Candidates should have at least 2 years of experience in warehouse operations, preferably in the pharmaceutical or food industry. Good German language skills are required, and English skills are a plus.
Experience Required
Minimum 2 year(s)
Quality Specialist II at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Berkeley, Missouri, United States - Full Time
Skills Needed
Root Cause Analysis, Capa Processes, Problem Solving, Regulatory Requirements, Quality Management Systems, Analytical Skills, Communication Skills, Project Management, Critical Thinking, Team Leadership, Manufacturing, Quality Assurance, Process Development, Gmp, Lean, Six Sigma
Specialization
A BS/BA degree is required along with 5+ years of experience in the biotech or pharmaceutical industry. Candidates should have strong problem-solving skills and experience with regulatory requirements and quality systems.
Experience Required
Minimum 5 year(s)
Assistant CRA at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Municipio de Eldorado, Misiones, Argentina - Full Time
Skills Needed
Medical Knowledge, Communication Skills, Interpersonal Skills, Organizational Skills, Time Management, Attention To Detail, Critical Thinking, Problem Solving, Computer Skills, Ms Office, Regulatory Knowledge, Teamwork, Adaptability, Document Management, Vendor Coordination, Training Skills
Specialization
A bachelor's degree in a life science discipline or equivalent is required, along with 0 to 2 years of relevant experience. Candidates should possess basic medical knowledge and effective communication skills.
Experienced Clinical Research Associate (FSP) (CRA II / Senior CRA)- Quebec at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Montreal, Quebec, Canada - Full Time
Skills Needed
Clinical Monitoring, Site Management, Regulatory Compliance, Risk Based Monitoring, Critical Thinking, Problem Solving, Data Accuracy, Communication Skills, Interpersonal Skills, Attention To Detail, Organizational Skills, Time Management, Microsoft Office, Bilingual, Neurology
Specialization
Candidates must have a bachelor's degree in a life sciences field or equivalent, along with CRA experience in neurology and bilingual proficiency in French and English. A valid driver's license is required, and a minimum of 2 years of relevant experience is preferred.
Experience Required
Minimum 2 year(s)
Scientist I - Analytical Operations - Co-Op at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Mississauga, Ontario, Canada - Full Time
Skills Needed
Analytical Testing, Hplc, Dissolution Testing, Physical Testing, Empower Software, Nugenesis Software, Microsoft Word, Microsoft Excel, Troubleshooting, Quality Assurance, Regulatory Compliance, Problem Solving, Interpersonal Skills, Communication Skills, Mathematical Operations, Teamwork
Specialization
Candidates must be enrolled in a co-op program and working towards a B.Sc. in chemistry or a related field. Experience with common laboratory equipment and operations is required.
Scientist (Silica Chemistry) at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Vilnius, Vilnius County, Lithuania - Full Time
Skills Needed
Silica Chemistry, Synthetic Organic Chemistry, Inorganic Chemistry, Polymer Chemistry, Project Management, Data Analysis, Hplc Fundamentals, Mentorship, Collaboration, Documentation, Experiment Planning, Quality Control, Chemical Safety, Process Optimization, Technical Communication, Research
Specialization
Candidates should have an MS/PhD in a relevant science or engineering field and demonstrated experience in synthetic chemistry. Strong theoretical knowledge and practical skills in synthesis methods and reaction mechanisms are essential.
Experience Required
Minimum 2 year(s)
Compliance Specialist III at THERMO FISHER BIOPHARMA SERVICES PTE LTD
, Ohio, United States - Full Time
Skills Needed
Compliance Management, Problem Solving, Regulatory Expertise, Data Management, Critical Thinking, Decision Making, Communication, Adaptability, Import Compliance, Data Analysis, Record Keeping, Collaboration, Autonomy, Prioritization, Risk Mitigation, Regulation Monitoring
Specialization
Candidates must possess a bachelor's degree and have at least 5 years of proven experience in compliance, particularly in import compliance. Extensive knowledge of import regulations, proficiency in data management tools, and strong problem-solving and communication skills are essential.
Experience Required
Minimum 5 year(s)
Manufacturing Supervisor at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Lenexa, Kansas, United States - Full Time
Skills Needed
Manufacturing Processes, Leadership, Team Building, Production Operations, Problem Solving, Analytical Skills, Collaboration, Microsoft Office Suite, Sap, Bilingual Communication
Specialization
Candidates must have a Bachelor's degree in Engineering or Science and a minimum of 4 years of manufacturing experience, including 2 years in a leadership role. Strong problem-solving skills and the ability to work in a fast-paced environment are essential.
Experience Required
Minimum 5 year(s)
Principal Medical Writer (Regulatory MW) at THERMO FISHER BIOPHARMA SERVICES PTE LTD
, Ohio, United States -
Full Time

Start Date

Immediate

Expiry Date

21 Feb, 26

Salary

0.0

Posted On

23 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Medical Writing, Project Management, Interpersonal Skills, Problem Solving, Negotiation, Data Interpretation, Regulatory Requirements, Editing, Proofreading, Communication Skills, Presentation Skills, Document Management Systems, Software Development, Clinical Research, Therapeutic Areas, Mentorship

Industry

Biotechnology Research

Description
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Principal Medical Writer 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. Our Medical Writing team is growing, and we are looking for a Principal Medical Writer. This role is based in the United States. Discover Impactful Work: Lead ambitious initiatives that craft the future of clinical research. Your expertise will enable us to deliver flawless Regulatory Medical Writing documents, such as protocols, CSR, Investigator Brochures, and Marketing Applications, ensuring outstanding quality and compliance. A Day in the Life: Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies. May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. As an essential advisory member of the writing team, may provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development strategy, document types, regulatory requirements, and industry best practices. May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications. Keys to Success: Acts with intensity Strong project management skills Excellent interpersonal skills including problem solving and negotiation Able to perform a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Education Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred Experience Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). Experience in managing and directing complex Regulatory medical writing projects required Experience working in the pharmaceutical/CRO industry preferred Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous. Knowledge, Skills, Abilities Significant knowledge of global, regional, national and other document development guidelines Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, marketing application submissions, communications, etc Strong project management skills Excellent interpersonal skills including problem solving and decision-making Strong negotiation skills Excellent oral and written communication skills with strong presentation skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook); willingness to utilize technology to support authoring efficiency Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! What We Offer: As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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Responsibilities
Lead the development of high-quality regulatory medical writing documents, ensuring compliance and accuracy. Provide mentorship and training to junior writers while managing complex writing projects.
Principal Medical Writer (Regulatory MW) at THERMO FISHER BIOPHARMA SERVICES PTE LTD
, Ohio, United States - Full Time
Skills Needed
Medical Writing, Project Management, Interpersonal Skills, Problem Solving, Negotiation, Data Interpretation, Regulatory Requirements, Editing, Proofreading, Communication Skills, Presentation Skills, Document Management Systems, Software Development, Clinical Research, Therapeutic Areas, Mentorship
Specialization
A bachelor's degree in a scientific discipline is required, with an advanced degree preferred. Candidates should have at least 8 years of experience in regulatory medical writing and knowledge of global document development guidelines.
Experience Required
Minimum 10 year(s)
Biotech Portfolio Lead, Sr. Director - US, West Coast Region at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Bothell, Washington, United States - Full Time
Skills Needed
Strategic Direction, Business Development, Project Management, Financial Analysis, Interpersonal Skills, Regulatory Guidelines, Marketing Skills, Negotiation Skills, Resource Management, Process Enhancement, Coaching, Consultancy, Operational Performance, Client Relationship Management, Cultural Awareness
Specialization
Candidates must have 15+ years of relevant experience and demonstrate strong financial analysis and interpersonal skills. A Bachelor's degree is preferred, but equivalent experience is accepted.
Experience Required
Minimum 10 year(s)
Senior Order Support Specialist - Dutch Speaking at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Budapest, Budapest, Hungary - Full Time
Skills Needed
Customer Service, Order Management, Problem Solving, Attention To Detail, Communication Skills, Organizational Skills, Self Motivation, Team Player, Judgment, Diplomacy, Microsoft Office, Multitasking, Data Accuracy, Proactive Mindset, Erp Systems, Training Development
Specialization
A minimum of 2-3 years of customer service experience is required, preferably in an SSC or multinational environment. Candidates should possess a high school diploma, with a bachelor's degree preferred but not essential.
Experience Required
Minimum 2 year(s)
Director, Customer Care at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Bengaluru, karnataka, India - Full Time
Skills Needed
Customer Care, Leadership, Team Management, Customer Engagement, Operational Efficiency, Change Management, Revenue Opportunities, Performance Standards, Business Processes, Market Trends, Technology Solutions, Continuous Improvement, Safety, Communication, Budget Management, Emergency Plans
Specialization
Candidates must have a bachelor's degree or equivalent experience and proven experience in leading customer service organizations at a senior management level. Extensive background in nurturing leadership skills and managing large teams is essential.
Experience Required
Minimum 10 year(s)
Technician at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Stone, England, United Kingdom - Full Time
Skills Needed
Laboratory Experience, Attention To Detail, Organizational Skills, Written Communication, Verbal Communication, Teamwork, Problem Solving, Gmp Compliance, Equipment Maintenance, Inventory Management, Documentation, Safety Policies, Training, Sops, Production Troubleshooting, Process Improvements
Specialization
Previous laboratory experience is preferred but not essential, along with familiarity with laboratory equipment and procedures. Strong attention to detail, organizational skills, and the ability to follow instructions are crucial for this role.
Account Manager (m/w/d) Life sciences research consumables and instruments at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Berlin, Guerrero, Germany - Full Time
Skills Needed
Sales, Customer Relationships, Account Planning, Collaboration, Time Management, Analytical Skills, Business Planning, Digital Literacy, Flexibility, Self Motivation, Communication, Life Sciences Knowledge, Team Contribution, Customer Experience, Product Knowledge, Language Proficiency
Specialization
Candidates should have a master's degree or equivalent experience, preferably in a biology or life science field, along with experience in sales within the Life Sciences market. Strong analytical, time-management, and communication skills are essential, along with proficiency in English and German.
Experience Required
Minimum 2 year(s)
Senior Quality Engineer at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Singapore, , Singapore - Full Time
Skills Needed
Quality Assurance, Data Analysis, Process Improvement, Audits, Compliance, Change Management, Statistical Controls, Communication, Interpersonal Skills, Internal Auditor, Lead Auditor, Risk Management, Sop Construction, Corrective Actions, Preventive Actions, Quality Management System
Specialization
A bachelor's degree in Science, Engineering, or equivalent is required, along with a minimum of 5 years of experience in a QA function, preferably in a medical devices or ISO 13485 environment. Candidates should possess strong communication skills and a proactive attitude.
Experience Required
Minimum 5 year(s)
Manufacturing Planner/Scheduler II at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Ferentino, Lazio, Italy - Full Time
Skills Needed
Manufacturing Planning, Scheduling, Analytical Skills, Problem Solving, Organizational Skills, Attention To Detail, Project Management, Communication Skills, Collaboration Skills, Inclusivity, Teamwork, Manufacturing Software Proficiency, Data Analysis, Excel Skills, Sap Proficiency, Materials Management, Production Planning
Specialization
Proven experience in manufacturing planning and scheduling is required, along with strong analytical and problem-solving skills. Candidates should have a bachelor's or master's degree in relevant fields and at least 2-4 years of experience in a production planning/scheduling role.
Experience Required
Minimum 2 year(s)
Technical Writer (User Documentation) at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Vilnius, Vilnius County, Lithuania - Full Time
Skills Needed
Technical Writing, User Documentation, Project Management, Collaboration, Dita Standards, Xml Authoring, Html, Css, Attention To Detail, Interpersonal Skills, Scientific Knowledge, Content Management, Agile Methodologies, Content Organization, Critical Thinking, Process Guidelines
Specialization
A bachelor's degree in science is required, with an advanced degree preferred. Candidates should have writing experience in a scientific environment and familiarity with DITA and XML authoring tools.
Experience Required
Minimum 2 year(s)
Sr Sales Support Coordinator at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Town of Grand Island, New York, United States - Full Time
Skills Needed
Customer Service, Order Entry, Salesforce, Erp Systems, Microsoft Office Suite, Attention To Detail, Communication Skills, Multitasking, Self Motivation, Team Oriented, Confidentiality, Sound Judgment, Inventory Management, Shipping Processes, Accounting Terminology
Specialization
A high school diploma or equivalent is required, with a preference for a bachelor's degree in business administration or a scientific field. Candidates should have at least 1 year of related customer service experience and proficiency with Salesforce and ERP systems.
Clinical Quality Study Lead at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Inscuinatoyac, Guerrero, Mexico - Full Time
Skills Needed
Clinical Quality Oversight, Gcp Compliance, Quality Principles, Risk Management, Fda Regulations, Eu Regulations, Ich Guidelines, Stakeholder Engagement, Audit Coordination, Inspection Readiness, Clinical Development, Quality Insights, Team Collaboration, Process Improvement, Motivation, Education
Specialization
Candidates should have in-depth knowledge of clinical trial regulations and Good Clinical Practices (GCP). The role requires the ability to motivate and educate study teams on clinical quality aspects and build effective relationships with stakeholders.
Experience Required
Minimum 5 year(s)
Localization Engineer, EMEA at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Madrid, Matruh, Egypt - Full Time
Skills Needed
Json, Resx, Vtt, Html, Xml, Madcap Flare, Dita, Articulate, Mp4, Captivate, Cat Tool, Content Management Systems, Localization Engineering, Programming Languages, Process Automation, Troubleshooting
Specialization
Candidates should have experience with various file formats and localization tools, as well as programming knowledge. A bachelor's degree and approximately 5 years of relevant experience are required.
Experience Required
Minimum 5 year(s)
Senior Material Handler at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Allschwil, Basel-Landschaft, Switzerland - Full Time
Skills Needed
Material Handling, Gmp Compliance, Team Coordination, Inventory Management, Labeling, Quality Assurance, Process Improvement, Self Management, Flexibility, Computer Skills, Ms Office, Initiative, Communication, German Language, English Language, Pharmaceutical Industry
Specialization
Candidates should have at least 2 years of experience in warehouse operations, preferably in the pharmaceutical or food industry. Good German language skills are required, and English skills are a plus.
Experience Required
Minimum 2 year(s)
Quality Specialist II at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Berkeley, Missouri, United States - Full Time
Skills Needed
Root Cause Analysis, Capa Processes, Problem Solving, Regulatory Requirements, Quality Management Systems, Analytical Skills, Communication Skills, Project Management, Critical Thinking, Team Leadership, Manufacturing, Quality Assurance, Process Development, Gmp, Lean, Six Sigma
Specialization
A BS/BA degree is required along with 5+ years of experience in the biotech or pharmaceutical industry. Candidates should have strong problem-solving skills and experience with regulatory requirements and quality systems.
Experience Required
Minimum 5 year(s)
Assistant CRA at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Municipio de Eldorado, Misiones, Argentina - Full Time
Skills Needed
Medical Knowledge, Communication Skills, Interpersonal Skills, Organizational Skills, Time Management, Attention To Detail, Critical Thinking, Problem Solving, Computer Skills, Ms Office, Regulatory Knowledge, Teamwork, Adaptability, Document Management, Vendor Coordination, Training Skills
Specialization
A bachelor's degree in a life science discipline or equivalent is required, along with 0 to 2 years of relevant experience. Candidates should possess basic medical knowledge and effective communication skills.
Experienced Clinical Research Associate (FSP) (CRA II / Senior CRA)- Quebec at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Montreal, Quebec, Canada - Full Time
Skills Needed
Clinical Monitoring, Site Management, Regulatory Compliance, Risk Based Monitoring, Critical Thinking, Problem Solving, Data Accuracy, Communication Skills, Interpersonal Skills, Attention To Detail, Organizational Skills, Time Management, Microsoft Office, Bilingual, Neurology
Specialization
Candidates must have a bachelor's degree in a life sciences field or equivalent, along with CRA experience in neurology and bilingual proficiency in French and English. A valid driver's license is required, and a minimum of 2 years of relevant experience is preferred.
Experience Required
Minimum 2 year(s)
Scientist I - Analytical Operations - Co-Op at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Mississauga, Ontario, Canada - Full Time
Skills Needed
Analytical Testing, Hplc, Dissolution Testing, Physical Testing, Empower Software, Nugenesis Software, Microsoft Word, Microsoft Excel, Troubleshooting, Quality Assurance, Regulatory Compliance, Problem Solving, Interpersonal Skills, Communication Skills, Mathematical Operations, Teamwork
Specialization
Candidates must be enrolled in a co-op program and working towards a B.Sc. in chemistry or a related field. Experience with common laboratory equipment and operations is required.
Scientist (Silica Chemistry) at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Vilnius, Vilnius County, Lithuania - Full Time
Skills Needed
Silica Chemistry, Synthetic Organic Chemistry, Inorganic Chemistry, Polymer Chemistry, Project Management, Data Analysis, Hplc Fundamentals, Mentorship, Collaboration, Documentation, Experiment Planning, Quality Control, Chemical Safety, Process Optimization, Technical Communication, Research
Specialization
Candidates should have an MS/PhD in a relevant science or engineering field and demonstrated experience in synthetic chemistry. Strong theoretical knowledge and practical skills in synthesis methods and reaction mechanisms are essential.
Experience Required
Minimum 2 year(s)
Compliance Specialist III at THERMO FISHER BIOPHARMA SERVICES PTE LTD
, Ohio, United States - Full Time
Skills Needed
Compliance Management, Problem Solving, Regulatory Expertise, Data Management, Critical Thinking, Decision Making, Communication, Adaptability, Import Compliance, Data Analysis, Record Keeping, Collaboration, Autonomy, Prioritization, Risk Mitigation, Regulation Monitoring
Specialization
Candidates must possess a bachelor's degree and have at least 5 years of proven experience in compliance, particularly in import compliance. Extensive knowledge of import regulations, proficiency in data management tools, and strong problem-solving and communication skills are essential.
Experience Required
Minimum 5 year(s)
Manufacturing Supervisor at THERMO FISHER BIOPHARMA SERVICES PTE LTD
Lenexa, Kansas, United States - Full Time
Skills Needed
Manufacturing Processes, Leadership, Team Building, Production Operations, Problem Solving, Analytical Skills, Collaboration, Microsoft Office Suite, Sap, Bilingual Communication
Specialization
Candidates must have a Bachelor's degree in Engineering or Science and a minimum of 4 years of manufacturing experience, including 2 years in a leadership role. Strong problem-solving skills and the ability to work in a fast-paced environment are essential.
Experience Required
Minimum 5 year(s)