31 empleos en ThermoFisher Scientific
Lead Biostatistician - Pharmacovigilance (PV) Focus
Remoto
ThermoFisher Scientific
Ayer
Trabajo visto
Descripción Del Trabajo
**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 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.
**More about our CorEvitas team:**
The Biostatistics team for the Real-World Science department uses specialized statistical expertise to perform analyses such as assessing prescribing patterns, comparing effectiveness between treatments, and investigating differences in safety outcomes using complex longitudinal prospective and registry data. **_The team is comprised of key focus areas: query work, pharmacovigilance, and registry coordination._**
**What will you do in this role with our CorEvitas team?**
The Lead Biostatistician will serve as the statistical lead on high-profile pharmacovigilance (PV) and safety-focused projects and will work collaboratively with cross-functional teams to support long-term post-authorization safety studies (PASS) and other regulatory commitments. This individual will independently design studies, develop statistical analysis plans, oversee analyses, and provide strategic statistical leadership to ensure high-quality and scientifically rigorous real-world evidence generation. A few key responsibilities are listed below.
Leads the statistical design, analysis, interpretation, and reporting of pharmacovigilance and safety-focused observational studies using complex longitudinal registry data
Collaborates with investigators, epidemiologists, clinicians, and clients to develop protocols, Statistical Analysis Plans (SAPs), and analytic strategies that support client objectives and regulatory commitments
Independently performs advanced statistical analyses and sample size/power calculations in accordance with SAPs and industry best practices
Provides strategic statistical leadership and independently makes sound statistical decisions related to safety analyses and real-world evidence generation
Oversees and mentors Biostatistician I/II analysts and other junior staff, ensuring quality, accuracy, and consistency of statistical analyses and documentation
Develops and implements standardized methodologies, analytical templates, and programming approaches to improve efficiency, reproducibility, and consistency across projects
**Hiring requirements:**
**Education requirements**
PhD in Biostatistics, Statistics, Mathematics is preferred. A master's degree in these same areas is required.
**Experience requirements**
Minimum 5-8 years of applied statistical experience in clinical research, pharmaceutical, biotechnology, CRO, hospital or academic is required.
Demonstrated experience **leading complex observational research studies** , equivalent to 3 years is required.
**Experience with Pharmacovigilance or safety-focused analyses project lead experience is preferred.**
Experience working with complex longitudinal registry or real-world data required
Demonstrated knowledge of retrospective and prospective observational study designs and related methodologies required.
Experience with causal inference theory and methods strongly preferred
Experience supporting regulatory safety studies, post-authorization safety
studies (PASS), or related pharmacovigilance activities preferred
Experience mentoring or supervising junior biostatisticians preferred
Collaborative research experience with publications in peer-reviewed journals preferred
Advanced proficiency in R required; experience with SAS preferred
**Knowledge, Skills and Abilities**
Strong understanding of statistical methodology for observational and longitudinal data analyses
Knowledge of pharmacovigilance principles, safety data evaluation, and real-world evidence generation preferred
Ability to independently lead projects, prioritize competing deliverables, and manage multiple timelines effectively
Strong scientific, analytical, problem-solving, leadership, and communication skills
Demonstrated ability to collaborate effectively across cross-functional teams and communicate complex statistical concepts to technical and non-technical audiences
Strong attention to detail and commitment to high-quality, reproducible analyses and documentation
Requires excellent written communication skills and adherence to best practices for statistical programming and code documentation
Ability to make independent judgments under limited supervision
Strong interpersonal skills and a collaborative team-oriented mindset
**Location: Remote from home in the US! This role does not offer relocation benefits.**
***Must be legally authorized to work in the United States without sponsorship.**
***Must be able to pass a comprehensive background check, which includes a drug screening.**
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.
Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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 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.
**More about our CorEvitas team:**
The Biostatistics team for the Real-World Science department uses specialized statistical expertise to perform analyses such as assessing prescribing patterns, comparing effectiveness between treatments, and investigating differences in safety outcomes using complex longitudinal prospective and registry data. **_The team is comprised of key focus areas: query work, pharmacovigilance, and registry coordination._**
**What will you do in this role with our CorEvitas team?**
The Lead Biostatistician will serve as the statistical lead on high-profile pharmacovigilance (PV) and safety-focused projects and will work collaboratively with cross-functional teams to support long-term post-authorization safety studies (PASS) and other regulatory commitments. This individual will independently design studies, develop statistical analysis plans, oversee analyses, and provide strategic statistical leadership to ensure high-quality and scientifically rigorous real-world evidence generation. A few key responsibilities are listed below.
Leads the statistical design, analysis, interpretation, and reporting of pharmacovigilance and safety-focused observational studies using complex longitudinal registry data
Collaborates with investigators, epidemiologists, clinicians, and clients to develop protocols, Statistical Analysis Plans (SAPs), and analytic strategies that support client objectives and regulatory commitments
Independently performs advanced statistical analyses and sample size/power calculations in accordance with SAPs and industry best practices
Provides strategic statistical leadership and independently makes sound statistical decisions related to safety analyses and real-world evidence generation
Oversees and mentors Biostatistician I/II analysts and other junior staff, ensuring quality, accuracy, and consistency of statistical analyses and documentation
Develops and implements standardized methodologies, analytical templates, and programming approaches to improve efficiency, reproducibility, and consistency across projects
**Hiring requirements:**
**Education requirements**
PhD in Biostatistics, Statistics, Mathematics is preferred. A master's degree in these same areas is required.
**Experience requirements**
Minimum 5-8 years of applied statistical experience in clinical research, pharmaceutical, biotechnology, CRO, hospital or academic is required.
Demonstrated experience **leading complex observational research studies** , equivalent to 3 years is required.
**Experience with Pharmacovigilance or safety-focused analyses project lead experience is preferred.**
Experience working with complex longitudinal registry or real-world data required
Demonstrated knowledge of retrospective and prospective observational study designs and related methodologies required.
Experience with causal inference theory and methods strongly preferred
Experience supporting regulatory safety studies, post-authorization safety
studies (PASS), or related pharmacovigilance activities preferred
Experience mentoring or supervising junior biostatisticians preferred
Collaborative research experience with publications in peer-reviewed journals preferred
Advanced proficiency in R required; experience with SAS preferred
**Knowledge, Skills and Abilities**
Strong understanding of statistical methodology for observational and longitudinal data analyses
Knowledge of pharmacovigilance principles, safety data evaluation, and real-world evidence generation preferred
Ability to independently lead projects, prioritize competing deliverables, and manage multiple timelines effectively
Strong scientific, analytical, problem-solving, leadership, and communication skills
Demonstrated ability to collaborate effectively across cross-functional teams and communicate complex statistical concepts to technical and non-technical audiences
Strong attention to detail and commitment to high-quality, reproducible analyses and documentation
Requires excellent written communication skills and adherence to best practices for statistical programming and code documentation
Ability to make independent judgments under limited supervision
Strong interpersonal skills and a collaborative team-oriented mindset
**Location: Remote from home in the US! This role does not offer relocation benefits.**
***Must be legally authorized to work in the United States without sponsorship.**
***Must be able to pass a comprehensive background check, which includes a drug screening.**
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.
Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Postúlese Ahora
0
SR CRA (Level II)
Remoto
ThermoFisher Scientific
Ayer
Trabajo visto
Descripción Del Trabajo
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a SR Clinical Research Associate (Level II) - Make an Impact at the Forefront of Innovation
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.
As part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
What You'll Do:
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
- Participates in investigator meetings as necessary. Identifies potential
- investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Responds to company, client and applicable regulatory requirements/audits/inspections.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
- Contributes to other project work and initiatives for process improvement, as required.
Education and Experience Requirements:
- Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
- Valid driver's license where applicable.
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 and Abilities:
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving
- Ability to manage Risk Based Monitoring concepts and processes
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Ability to remain flexibile and adaptable in a wide range of scenarios
- Ability to work in a team or independently as required
- Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
Working Conditions and Environment:
- Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
- Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Exposure to fluctuating and/or extreme temperatures on rare occasions
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a SR Clinical Research Associate (Level II) - Make an Impact at the Forefront of Innovation
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.
As part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
What You'll Do:
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
- Participates in investigator meetings as necessary. Identifies potential
- investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Responds to company, client and applicable regulatory requirements/audits/inspections.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
- Contributes to other project work and initiatives for process improvement, as required.
Education and Experience Requirements:
- Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
- Valid driver's license where applicable.
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 and Abilities:
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving
- Ability to manage Risk Based Monitoring concepts and processes
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Ability to remain flexibile and adaptable in a wide range of scenarios
- Ability to work in a team or independently as required
- Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
Working Conditions and Environment:
- Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
- Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Exposure to fluctuating and/or extreme temperatures on rare occasions
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Postúlese Ahora
1
ICF Program Manager
Remoto
ThermoFisher Scientific
Publicado hace 6 días
Trabajo visto
Descripción Del Trabajo
**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 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.
We have a vacancy for an ICF Medical Writing Program Manager based in Latin America.
Discover Impactful Work:
Lead patient-centric medical writing programs with a focus on Informed Consent Forms (ICFs). Manage complex projects, engage with clients, and ensure flawless delivery and quality of documents, contributing to world-class research outcomes.
A day in the Life:
- Develop and adapt project plans and timelines.
- Engage and manage client relationships.
- Collaborate with cross-functional teams.
- Monitor project progress and provide status updates.
- Mentor junior staff and ensure compliance with quality processes.
Keys to Success:
- Advanced project management skills.
- Outstanding planning and organizational abilities.
- Excellent communication, negotiation, and decision-making skills.
- In-depth knowledge of regulatory and document development guidelines.
- Proven ability to lead and mentor junior staff.
Education
- BS/BA (preferably in a scientific field) with a minimum of 8 years of relevant experience, or an advanced degree with a minimum of 6 years of relevant experience.
Experience
- Experience managing medical writing or clinical projects.
- Experience working in the pharmaceutical/CRO industry.
- Preferably, experience in medical writing (Regulatory and/or plain language).
Knowledge, Skills, Abilities
- Advanced skills in budgeting, forecasting, and resource management.
- Expert planning and organizational skills.
- Excellent interpersonal and communication skills.
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 organisation 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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 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.
We have a vacancy for an ICF Medical Writing Program Manager based in Latin America.
Discover Impactful Work:
Lead patient-centric medical writing programs with a focus on Informed Consent Forms (ICFs). Manage complex projects, engage with clients, and ensure flawless delivery and quality of documents, contributing to world-class research outcomes.
A day in the Life:
- Develop and adapt project plans and timelines.
- Engage and manage client relationships.
- Collaborate with cross-functional teams.
- Monitor project progress and provide status updates.
- Mentor junior staff and ensure compliance with quality processes.
Keys to Success:
- Advanced project management skills.
- Outstanding planning and organizational abilities.
- Excellent communication, negotiation, and decision-making skills.
- In-depth knowledge of regulatory and document development guidelines.
- Proven ability to lead and mentor junior staff.
Education
- BS/BA (preferably in a scientific field) with a minimum of 8 years of relevant experience, or an advanced degree with a minimum of 6 years of relevant experience.
Experience
- Experience managing medical writing or clinical projects.
- Experience working in the pharmaceutical/CRO industry.
- Preferably, experience in medical writing (Regulatory and/or plain language).
Knowledge, Skills, Abilities
- Advanced skills in budgeting, forecasting, and resource management.
- Expert planning and organizational skills.
- Excellent interpersonal and communication skills.
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 organisation 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Postúlese Ahora
2
FSP Vendor Management Specialist
Remoto
ThermoFisher Scientific
Publicado hace 6 días
Trabajo visto
Descripción Del Trabajo
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Clinical Vendor Oversight Specialist**
**Make an impact. Advance science. Grow your career.**
At Thermo Fisher Scientific, you'll be part of a global team committed to making the world healthier, cleaner, and safer. Every day, our colleagues contribute to groundbreaking research and innovative clinical solutions that help accelerate the development of life-changing therapies for patients around the world.
If you're passionate about clinical operations, vendor management, and driving operational excellence, this is your opportunity to join a collaborative, high-performing team where your work truly makes a difference.
**What you'll do**
As a Clinical Vendor Oversight Specialist, you will play a key role in ensuring the successful execution of clinical studies by managing relationships with third-party vendors and collaborating closely with cross-functional teams.
Your responsibilities will include:
+ Lead day-to-day oversight of study vendors throughout the clinical trial lifecycle.
+ Coordinate vendor activities, ensuring timelines, quality expectations, and study deliverables are achieved.
+ Develop study-specific vendor management plans and vendor oversight documentation.
+ Partner with Study Management Teams (SMTs), Functional Subject Matter Experts, Procurement, and Quality teams to ensure seamless study execution.
+ Monitor vendor performance through KPIs and regular governance meetings, driving continuous improvement.
+ Identify, assess, and proactively mitigate vendor-related risks.
+ Escalate issues appropriately and work collaboratively to achieve timely resolution.
+ Maintain accurate vendor documentation and study information within internal systems.
+ Support invoice transparency by identifying potential discrepancies and communicating with Clinical Trial Leads.
+ Ensure vendor compliance with GCP, ICH guidelines, regulatory requirements, and company procedures.
**What we're looking for**
**Required Qualifications**
+ 2+ years of experience in Clinical Operations, Clinical Study Management, or Vendor Management within a Sponsor or CRO environment.
+ Experience managing clinical studies while balancing quality, timelines, and budget expectations.
+ Strong project management, communication, stakeholder management, and cross-functional collaboration skills.
+ Knowledge of clinical study management across one or more clinical phases (Phase I, II, or III).
+ Solid understanding of Good Clinical Practice (GCP), ICH Guidelines, and global clinical research regulations.
+ Demonstrated experience managing external vendors and ensuring successful study delivery.
**Preferred Qualifications**
+ Bachelor's degree or Associate's degree in a related field.
+ Previous experience overseeing third-party vendors within clinical studies.
**Why join Thermo Fisher Scientific?**
+ Be part of an organization whose work directly impacts patients' lives worldwide.
+ Collaborate with global teams on innovative clinical development programs.
+ Work in an environment that values inclusion, collaboration, and continuous learning.
+ Access outstanding career development opportunities within one of the world's leading life sciences organizations.
+ Contribute to meaningful work while building a long-term career with a company committed to advancing science and improving human health.
Join us and help accelerate the future of clinical research.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Clinical Vendor Oversight Specialist**
**Make an impact. Advance science. Grow your career.**
At Thermo Fisher Scientific, you'll be part of a global team committed to making the world healthier, cleaner, and safer. Every day, our colleagues contribute to groundbreaking research and innovative clinical solutions that help accelerate the development of life-changing therapies for patients around the world.
If you're passionate about clinical operations, vendor management, and driving operational excellence, this is your opportunity to join a collaborative, high-performing team where your work truly makes a difference.
**What you'll do**
As a Clinical Vendor Oversight Specialist, you will play a key role in ensuring the successful execution of clinical studies by managing relationships with third-party vendors and collaborating closely with cross-functional teams.
Your responsibilities will include:
+ Lead day-to-day oversight of study vendors throughout the clinical trial lifecycle.
+ Coordinate vendor activities, ensuring timelines, quality expectations, and study deliverables are achieved.
+ Develop study-specific vendor management plans and vendor oversight documentation.
+ Partner with Study Management Teams (SMTs), Functional Subject Matter Experts, Procurement, and Quality teams to ensure seamless study execution.
+ Monitor vendor performance through KPIs and regular governance meetings, driving continuous improvement.
+ Identify, assess, and proactively mitigate vendor-related risks.
+ Escalate issues appropriately and work collaboratively to achieve timely resolution.
+ Maintain accurate vendor documentation and study information within internal systems.
+ Support invoice transparency by identifying potential discrepancies and communicating with Clinical Trial Leads.
+ Ensure vendor compliance with GCP, ICH guidelines, regulatory requirements, and company procedures.
**What we're looking for**
**Required Qualifications**
+ 2+ years of experience in Clinical Operations, Clinical Study Management, or Vendor Management within a Sponsor or CRO environment.
+ Experience managing clinical studies while balancing quality, timelines, and budget expectations.
+ Strong project management, communication, stakeholder management, and cross-functional collaboration skills.
+ Knowledge of clinical study management across one or more clinical phases (Phase I, II, or III).
+ Solid understanding of Good Clinical Practice (GCP), ICH Guidelines, and global clinical research regulations.
+ Demonstrated experience managing external vendors and ensuring successful study delivery.
**Preferred Qualifications**
+ Bachelor's degree or Associate's degree in a related field.
+ Previous experience overseeing third-party vendors within clinical studies.
**Why join Thermo Fisher Scientific?**
+ Be part of an organization whose work directly impacts patients' lives worldwide.
+ Collaborate with global teams on innovative clinical development programs.
+ Work in an environment that values inclusion, collaboration, and continuous learning.
+ Access outstanding career development opportunities within one of the world's leading life sciences organizations.
+ Contribute to meaningful work while building a long-term career with a company committed to advancing science and improving human health.
Join us and help accelerate the future of clinical research.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Postúlese Ahora
3
Logistics Specialist I
Bogotá
ThermoFisher Scientific
Publicado hace 7 días
Trabajo visto
Descripción Del Trabajo
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
DESCRIPTION:
Join our team at Thermo Fisher Scientific where you'll contribute to managing logistics operations for clinical trials, pharmaceutical products, and scientific equipment. As a Logistics Specialist I, you'll coordinate shipments, ensure regulatory compliance, and maintain supply chain operations. You'll handle order processing, documentation, inventory management, and work with internal teams and external partners to deliver excellent service. This position offers the opportunity to contribute to our mission of enabling customers to make the world healthier, cleaner, and safer.
**REQUIREMENTS:**
+ Bachelor's Degree required in Logistics, Supply Chain Management, Business Administration or related field
+ Experience in pharmaceutical logistics or in another high regulated industries such as food and beverage or cosmetics
+ Professional certifications in logistics, trade compliance, or dangerous goods handling are advantageous
+ Strong knowledge of shipping documentation, customs procedures, and international trade regulations
+ Proficient in ERP systems (SAP, Oracle, QAD) and Microsoft Office suite, particularly Excel
+ Intermediate English language skills, both written and verbal; additional languages beneficial
+ Detail-oriented with strong organizational and time management capabilities
+ Excellent communication and interpersonal skills for collaborating with internal/external stakeholders
+ Experience with GMP, GDP, and clinical trial regulations preferred
+ Ability to manage multiple priorities effectively
+ Problem-solving skills and ability to work independently
+ Strong customer service orientation
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
DESCRIPTION:
Join our team at Thermo Fisher Scientific where you'll contribute to managing logistics operations for clinical trials, pharmaceutical products, and scientific equipment. As a Logistics Specialist I, you'll coordinate shipments, ensure regulatory compliance, and maintain supply chain operations. You'll handle order processing, documentation, inventory management, and work with internal teams and external partners to deliver excellent service. This position offers the opportunity to contribute to our mission of enabling customers to make the world healthier, cleaner, and safer.
**REQUIREMENTS:**
+ Bachelor's Degree required in Logistics, Supply Chain Management, Business Administration or related field
+ Experience in pharmaceutical logistics or in another high regulated industries such as food and beverage or cosmetics
+ Professional certifications in logistics, trade compliance, or dangerous goods handling are advantageous
+ Strong knowledge of shipping documentation, customs procedures, and international trade regulations
+ Proficient in ERP systems (SAP, Oracle, QAD) and Microsoft Office suite, particularly Excel
+ Intermediate English language skills, both written and verbal; additional languages beneficial
+ Detail-oriented with strong organizational and time management capabilities
+ Excellent communication and interpersonal skills for collaborating with internal/external stakeholders
+ Experience with GMP, GDP, and clinical trial regulations preferred
+ Ability to manage multiple priorities effectively
+ Problem-solving skills and ability to work independently
+ Strong customer service orientation
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
¿Este trabajo es un acierto o un fracaso?
Postúlese Ahora
4
CTM - FSP
Remoto
ThermoFisher Scientific
Publicado hace 7 días
Trabajo visto
Descripción Del Trabajo
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation
The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.
What You'll Do:
- Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
- Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
- Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
- May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.
- May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
Education & 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 5+ 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:
- Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
- Good planning and organizational skills to enable effective prioritization of workload
- Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
- Capable of working effectively in a changing environment with complex/ambiguous situations
- Familiarity with the practices, processes, and requirements of clinical monitoring
- Good judgment and decision making skills
- Effective oral and written communication skills, including English language proficiency
- Capable of evaluating workload against project budget and adjusting resources accordingly
- Sound financial acument and knowledge of budgeting, forecasting and fiscal management
- Strong attention to detail
- Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
- Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Frequently drives to site locations and frequently travels 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation
The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.
What You'll Do:
- Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
- Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
- Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
- May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.
- May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
Education & 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 5+ 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:
- Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
- Good planning and organizational skills to enable effective prioritization of workload
- Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
- Capable of working effectively in a changing environment with complex/ambiguous situations
- Familiarity with the practices, processes, and requirements of clinical monitoring
- Good judgment and decision making skills
- Effective oral and written communication skills, including English language proficiency
- Capable of evaluating workload against project budget and adjusting resources accordingly
- Sound financial acument and knowledge of budgeting, forecasting and fiscal management
- Strong attention to detail
- Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
- Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Frequently drives to site locations and frequently travels 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
¿Este trabajo es un acierto o un fracaso?
Postúlese Ahora
5
Senior Medical Project Coordinator
Remoto
ThermoFisher Scientific
Publicado hace 12 días
Trabajo visto
Descripción Del Trabajo
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Join Us as a Senior Medical Project Coordinator**
At Thermo Fisher Scientific, you'll do meaningful work that makes a positive impact on global health. You'll be part of a global organization supporting leading pharmaceutical and biotechnology companies while contributing to the development of life-changing therapies. Through collaboration, innovation, and continuous learning, you'll have the opportunity to grow your career while helping advance clinical research worldwide.
**What You'll Do:**
The Senior Medical Project Coordinator manages, coordinates and evaluates medical projects for one or more programs in collaboration with management and other stakeholders to ensure consistency, alignment, and compliance of internal processes as well as optimal performance and issue resolution throughout project lifecycle. Represents the company in the medical research community and develops collaborative relationships with client company personnel.
- Work independently to perform first pass review of safety data, utilizing line
listings, company dashboard(s) and/or other visualization tools. Review data for
safety trends, coding consistencies, and potential follow up with investigator
sites. Proactively identify any potential issues and resolve or escalate as
appropriate.
- Review safety data and provide summations for safety review meetings.
Review designated sections of aggregate reports.
- Independently function as the Project Lead for medical monitoring services
when SAE case processing has not been contracted. Manage project
implementation, coordination, maintenance and close out of assigned studies as
applicable. Serve as the primary point of contact for clinical project teams on
studies and can act as the alliance level lead on larger alliance/multi-protocol
studies.
- Create and maintain medical management plan(s) on studies (as applicable)
and ensure that the processes included in the plan document are reflective of
the contract and services requested for studies that have department
involvement and those that are standalone studies (ex. MM and/or MPC).
- Work independently to monitor the project financial status, unit forecasting,
actual realization, and team allocations in systems. Coordinate staff projections
based on contract values and actual hours used. Escalate any financial and/or
operational risks and can attend risk management meetings to discuss.
- Independently determine hours required for out of scope work for the teams
and provide this to the finance/study team for contract modifications. Attend
meetings to discuss/justify the modification requirements.
- Resolve complex problems through in-depth evaluation of various factors and
offers solutions. May assist management in training and mentoring.
- Present at business development, client, and investigator meetings and
participates in strategy/business development calls. Represent studies at risk
management meetings.
**Education and Experience Requirements:**
- Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
5+ years), to include 5+ years clinical safety experience (clinical research monitoring, or
pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)
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:**
- Advanced knowledge of GCPs for medical oversight of clinical trials
- Knowledge of drug development and safety reporting
- Advanced knowledge of safety data trending to include coding
- Working knowledge of biostatistics, data management and clinical procedures
- Excellent problem solving and critical thinking skills
- Excellent project management and budget skills
- Effective mentoring skills and ability to train and lead others
- Strong oral and written communication skills
- Strong attention to detail
- Ability to work in a collaborative team environment
- Ability to maintain a positive and professional demeanor in challenging circumstances
**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/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed in an office environment with exposure to electrical office equipment.
- Occasional drives to site locations, frequent travels 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Join Us as a Senior Medical Project Coordinator**
At Thermo Fisher Scientific, you'll do meaningful work that makes a positive impact on global health. You'll be part of a global organization supporting leading pharmaceutical and biotechnology companies while contributing to the development of life-changing therapies. Through collaboration, innovation, and continuous learning, you'll have the opportunity to grow your career while helping advance clinical research worldwide.
**What You'll Do:**
The Senior Medical Project Coordinator manages, coordinates and evaluates medical projects for one or more programs in collaboration with management and other stakeholders to ensure consistency, alignment, and compliance of internal processes as well as optimal performance and issue resolution throughout project lifecycle. Represents the company in the medical research community and develops collaborative relationships with client company personnel.
- Work independently to perform first pass review of safety data, utilizing line
listings, company dashboard(s) and/or other visualization tools. Review data for
safety trends, coding consistencies, and potential follow up with investigator
sites. Proactively identify any potential issues and resolve or escalate as
appropriate.
- Review safety data and provide summations for safety review meetings.
Review designated sections of aggregate reports.
- Independently function as the Project Lead for medical monitoring services
when SAE case processing has not been contracted. Manage project
implementation, coordination, maintenance and close out of assigned studies as
applicable. Serve as the primary point of contact for clinical project teams on
studies and can act as the alliance level lead on larger alliance/multi-protocol
studies.
- Create and maintain medical management plan(s) on studies (as applicable)
and ensure that the processes included in the plan document are reflective of
the contract and services requested for studies that have department
involvement and those that are standalone studies (ex. MM and/or MPC).
- Work independently to monitor the project financial status, unit forecasting,
actual realization, and team allocations in systems. Coordinate staff projections
based on contract values and actual hours used. Escalate any financial and/or
operational risks and can attend risk management meetings to discuss.
- Independently determine hours required for out of scope work for the teams
and provide this to the finance/study team for contract modifications. Attend
meetings to discuss/justify the modification requirements.
- Resolve complex problems through in-depth evaluation of various factors and
offers solutions. May assist management in training and mentoring.
- Present at business development, client, and investigator meetings and
participates in strategy/business development calls. Represent studies at risk
management meetings.
**Education and Experience Requirements:**
- Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
5+ years), to include 5+ years clinical safety experience (clinical research monitoring, or
pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)
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:**
- Advanced knowledge of GCPs for medical oversight of clinical trials
- Knowledge of drug development and safety reporting
- Advanced knowledge of safety data trending to include coding
- Working knowledge of biostatistics, data management and clinical procedures
- Excellent problem solving and critical thinking skills
- Excellent project management and budget skills
- Effective mentoring skills and ability to train and lead others
- Strong oral and written communication skills
- Strong attention to detail
- Ability to work in a collaborative team environment
- Ability to maintain a positive and professional demeanor in challenging circumstances
**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/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed in an office environment with exposure to electrical office equipment.
- Occasional drives to site locations, frequent travels 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
¿Este trabajo es un acierto o un fracaso?
Postúlese Ahora
6
Medical Project Coordinator
Remoto
ThermoFisher Scientific
Publicado hace 12 días
Trabajo visto
Descripción Del Trabajo
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join us as **Medical Project Coordinator** - And utilize your expertise to support and enhance drug safety operations, ensuring compliance with regulatory standards and optimal patient safety in clinical trials.
**What You'll Do:**
- Coordinate and review safety data, utilizing line listings, company dashboard(s) and/or other visualization tools. Review data for safety trends,
coding consistencies, and potential follow up with investigator sites. Identify potential issues and resolve or escalate as appropriate.
- Review safety data and may provide summations for safety review meetings.
- May review designated sections of aggregate reports.
- May help to create/review safety and medical management plan(s) on studies (as applicable) and ensures that the processes included in plan documents are reflective of the contract and services requested.
- May help manage routine project implementation, forecasting and coordination, including review of metrics and budget considerations.
- Monitor the status of the data review and escalate any delays and/or risks to all stakeholders, including study leads.
- May present at business development, client, and investigator meetings and participate in strategy/business development calls.
- Resolve complex problems through in-depth evaluation of various factors and offers solutions.
- May serve as the primary point of contact for clinical/data management project teams.
- May assist management in training and mentoring.
**Education and Experience:**
- Bachelor's degree in nursing or related Health Sciences (Physician's Assistant) or licensed RN
- Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 2+ years), to include 2+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)
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 and Abilities:**
- Knowledge of GCPs for medical oversight of clinical trials and SAE processing
- Knowledge of drug development and safety reporting
- Knowledge of safety data trending to include coding
- Working knowledge of biostatistics, data management and clinical procedures
- Strong problem solving and critical thinking skills
- Good oral and written communication skills
- Good attention to detail
- Ability to work in a collaborative team environment
- Ability to maintain a positive and professional demeanor in challenging circumstances
**Working Conditions and Environment:**
- Work is performed in an office/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves.
**Physical Requirements:**
- Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Performs 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 multitask.
- Regular and consistent attendance.
**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 breakthrough.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join us as **Medical Project Coordinator** - And utilize your expertise to support and enhance drug safety operations, ensuring compliance with regulatory standards and optimal patient safety in clinical trials.
**What You'll Do:**
- Coordinate and review safety data, utilizing line listings, company dashboard(s) and/or other visualization tools. Review data for safety trends,
coding consistencies, and potential follow up with investigator sites. Identify potential issues and resolve or escalate as appropriate.
- Review safety data and may provide summations for safety review meetings.
- May review designated sections of aggregate reports.
- May help to create/review safety and medical management plan(s) on studies (as applicable) and ensures that the processes included in plan documents are reflective of the contract and services requested.
- May help manage routine project implementation, forecasting and coordination, including review of metrics and budget considerations.
- Monitor the status of the data review and escalate any delays and/or risks to all stakeholders, including study leads.
- May present at business development, client, and investigator meetings and participate in strategy/business development calls.
- Resolve complex problems through in-depth evaluation of various factors and offers solutions.
- May serve as the primary point of contact for clinical/data management project teams.
- May assist management in training and mentoring.
**Education and Experience:**
- Bachelor's degree in nursing or related Health Sciences (Physician's Assistant) or licensed RN
- Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 2+ years), to include 2+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)
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 and Abilities:**
- Knowledge of GCPs for medical oversight of clinical trials and SAE processing
- Knowledge of drug development and safety reporting
- Knowledge of safety data trending to include coding
- Working knowledge of biostatistics, data management and clinical procedures
- Strong problem solving and critical thinking skills
- Good oral and written communication skills
- Good attention to detail
- Ability to work in a collaborative team environment
- Ability to maintain a positive and professional demeanor in challenging circumstances
**Working Conditions and Environment:**
- Work is performed in an office/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves.
**Physical Requirements:**
- Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Performs 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 multitask.
- Regular and consistent attendance.
**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 breakthrough.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Postúlese Ahora
7
Lead Medical Project Coordinator
Remoto
ThermoFisher Scientific
Publicado hace 12 días
Trabajo visto
Descripción Del Trabajo
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Join Us as a Lead Medical Project Coordinator**
At Thermo Fisher Scientific, your work will have a meaningful impact on global health. By supporting clinical research, you'll help advance life-changing therapies while growing your career in a collaborative and innovative environment.
As a Lead Medical Project Coordinator, you'll lead the coordination and oversight of medical projects, working closely with cross-functional teams and clients to ensure high-quality delivery, effective collaboration, and successful project execution throughout the study lifecycle.
**What You'll Do:**
- Work independently to perform and/or lead first pass review of safety data
utilizing line listings, company dashboard(s), and/or other visualization tools.
- Review data for safety trends, coding consistencies, and potential follow up
with investigator sites. Proactively identify any potential issues and resolve or
escalate as appropriate.
- Review safety data and provide comprehensive summations for safety review
meetings. Review designated sections of aggregate reports.
- Initiate and lead initiatives to improve current processes and develops new
processes regarding medical monitoring and department services. May develop
guidance documents and assist with the implementation and/or revision of
corporate level documents such as SOP's and WPD's.
- Independently function as the Project Lead for medical monitoring services
when SAE case processing has not been contracted. Manage project
implementation, coordination, maintenance and close out of assigned studies as
applicable. Serve as the primary point of contact for clinical project teams on
studies and can act as the alliance level lead on larger alliance/multi-protocol
studies.
- Create and maintain safety and medical management plan(s) on studies (as
applicable) and ensure that the processes included in the plan document are
reflective of the contract and service requested for studies that have
department involvement as well as standalone studies (ex. MM and/or MPC).
- Work independently to monitor the project financial status, unit forecasting,
actual realization, and team allocations in systems. Coordinate staff
projections based on contract values and actual hours used. Escalate any
financial and/or operational risks and can attend risk management meetings to
discuss.
- Present at business development, client, and investigator meetings and
participate in strategy/business development calls. Represent studies at risk
management meetings.
- Independently determine hours required for out of scope work for both the MM
and MPC and provides this to the finance/study team for contract modifications.
Attend meetings to discuss/justify the modification requirements.
- Train and develop new team members. Serve as main point of contact for
team member questions with escalation to management as appropriate. May
provide input on individual performance to direct line manager. Organize and
lead meetings with team members to discuss potential process issues, answer
questions, and brainstorm ideas and solutions.
- Resolve complex problems through in-depth evaluation of various factors and
offers solutions.
**Education and Experience Requirements:**
- Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years), to include 8+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)
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:**
- Superior knowledge of GCPs for medical oversight of clinical trials
- Advanced knowledge of drug development and safety reporting
- Extensive knowledge of safety data trending to include coding
- Good knowledge of biostatistics, data management and clinical procedures
- Exceptional problem solving and critical thinking skills
- Exceptional project management and budget skills
- Excellent mentoring skills and ability to train and lead others
- Exceptional oral and written communication skills
- Detail-oriented mindset
- Able to work in a collaborative team environment
- Ability to maintain a positive and professional demeanor in challenging circumstances
**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/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves
**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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Join Us as a Lead Medical Project Coordinator**
At Thermo Fisher Scientific, your work will have a meaningful impact on global health. By supporting clinical research, you'll help advance life-changing therapies while growing your career in a collaborative and innovative environment.
As a Lead Medical Project Coordinator, you'll lead the coordination and oversight of medical projects, working closely with cross-functional teams and clients to ensure high-quality delivery, effective collaboration, and successful project execution throughout the study lifecycle.
**What You'll Do:**
- Work independently to perform and/or lead first pass review of safety data
utilizing line listings, company dashboard(s), and/or other visualization tools.
- Review data for safety trends, coding consistencies, and potential follow up
with investigator sites. Proactively identify any potential issues and resolve or
escalate as appropriate.
- Review safety data and provide comprehensive summations for safety review
meetings. Review designated sections of aggregate reports.
- Initiate and lead initiatives to improve current processes and develops new
processes regarding medical monitoring and department services. May develop
guidance documents and assist with the implementation and/or revision of
corporate level documents such as SOP's and WPD's.
- Independently function as the Project Lead for medical monitoring services
when SAE case processing has not been contracted. Manage project
implementation, coordination, maintenance and close out of assigned studies as
applicable. Serve as the primary point of contact for clinical project teams on
studies and can act as the alliance level lead on larger alliance/multi-protocol
studies.
- Create and maintain safety and medical management plan(s) on studies (as
applicable) and ensure that the processes included in the plan document are
reflective of the contract and service requested for studies that have
department involvement as well as standalone studies (ex. MM and/or MPC).
- Work independently to monitor the project financial status, unit forecasting,
actual realization, and team allocations in systems. Coordinate staff
projections based on contract values and actual hours used. Escalate any
financial and/or operational risks and can attend risk management meetings to
discuss.
- Present at business development, client, and investigator meetings and
participate in strategy/business development calls. Represent studies at risk
management meetings.
- Independently determine hours required for out of scope work for both the MM
and MPC and provides this to the finance/study team for contract modifications.
Attend meetings to discuss/justify the modification requirements.
- Train and develop new team members. Serve as main point of contact for
team member questions with escalation to management as appropriate. May
provide input on individual performance to direct line manager. Organize and
lead meetings with team members to discuss potential process issues, answer
questions, and brainstorm ideas and solutions.
- Resolve complex problems through in-depth evaluation of various factors and
offers solutions.
**Education and Experience Requirements:**
- Bachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years), to include 8+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)
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:**
- Superior knowledge of GCPs for medical oversight of clinical trials
- Advanced knowledge of drug development and safety reporting
- Extensive knowledge of safety data trending to include coding
- Good knowledge of biostatistics, data management and clinical procedures
- Exceptional problem solving and critical thinking skills
- Exceptional project management and budget skills
- Excellent mentoring skills and ability to train and lead others
- Exceptional oral and written communication skills
- Detail-oriented mindset
- Able to work in a collaborative team environment
- Ability to maintain a positive and professional demeanor in challenging circumstances
**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/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves
**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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
¿Este trabajo es un acierto o un fracaso?
Postúlese Ahora
8
Associate Director, PPI Business System
Remoto
ThermoFisher Scientific
Publicado hace 13 días
Trabajo visto
Descripción Del Trabajo
**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 colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
As a Senior Manager of PPI Business System at Thermo Fisher Scientific, you will facilitate transformational change and continuous improvement across the organization. Leading the implementation of our Practical Process Improvement (PPI) Business System, you will partner with business leaders to establish and mature lean management practices that enable profitable growth, enhance customer experience, and increase employee engagement. Through strategic deployment, coaching, and hands-on facilitation of improvement initiatives, you will help develop a problem-solving culture focused on operational excellence. You'll collaborate with cross-functional teams to streamline processes, eliminate waste, and deliver measurable results in quality, productivity, and customer satisfaction.
REQUIREMENTS:
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in lean leadership implementing continuous improvement initiatives
- Preferred Fields of Study: Engineering, Science, Business, Operations or related field
- Six Sigma Black Belt and/or Lean certification preferred
- Project Management Professional (PMP) certification a plus
- Demonstrated experience developing and deploying PPI/lean tools including:
- Strategy deployment and value stream mapping
- Tiered daily management systems and leader standard work
- Kaizen facilitation and problem-solving methodologies
- Standard work, error-proofing, and visual management
- Strong financial and business acumen with ability to identify, quantify and track improvement opportunities
- Excellent communication, presentation and influence skills to engage all organizational levels
- Demonstrated success coaching and developing continuous improvement capabilities in others
- Experience leading change initiatives in a matrix organization
- Strong project management skills and ability to manage multiple priorities
- Ability to travel up to 30%
- Manufacturing/operations experience preferred
- Expertise in data analytics and performance metrics
- Proficiency in Microsoft Office suite required
- Commitment to driving improvement and leading transformational change
- Ability to work effectively across functions without direct authority
- Experience in regulated industry (e.g., life sciences, medical devices) preferred
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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 colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
As a Senior Manager of PPI Business System at Thermo Fisher Scientific, you will facilitate transformational change and continuous improvement across the organization. Leading the implementation of our Practical Process Improvement (PPI) Business System, you will partner with business leaders to establish and mature lean management practices that enable profitable growth, enhance customer experience, and increase employee engagement. Through strategic deployment, coaching, and hands-on facilitation of improvement initiatives, you will help develop a problem-solving culture focused on operational excellence. You'll collaborate with cross-functional teams to streamline processes, eliminate waste, and deliver measurable results in quality, productivity, and customer satisfaction.
REQUIREMENTS:
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in lean leadership implementing continuous improvement initiatives
- Preferred Fields of Study: Engineering, Science, Business, Operations or related field
- Six Sigma Black Belt and/or Lean certification preferred
- Project Management Professional (PMP) certification a plus
- Demonstrated experience developing and deploying PPI/lean tools including:
- Strategy deployment and value stream mapping
- Tiered daily management systems and leader standard work
- Kaizen facilitation and problem-solving methodologies
- Standard work, error-proofing, and visual management
- Strong financial and business acumen with ability to identify, quantify and track improvement opportunities
- Excellent communication, presentation and influence skills to engage all organizational levels
- Demonstrated success coaching and developing continuous improvement capabilities in others
- Experience leading change initiatives in a matrix organization
- Strong project management skills and ability to manage multiple priorities
- Ability to travel up to 30%
- Manufacturing/operations experience preferred
- Expertise in data analytics and performance metrics
- Proficiency in Microsoft Office suite required
- Commitment to driving improvement and leading transformational change
- Ability to work effectively across functions without direct authority
- Experience in regulated industry (e.g., life sciences, medical devices) preferred
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
¿Este trabajo es un acierto o un fracaso?
Postúlese Ahora
9