Thermo Fisher Scientific
Senior Compliance Specialist, FSP (Remote) - US
Thermo Fisher Scientific, New York, New York, United States
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Job Description
Join Thermo Fisher Scientific Inc. as an outstanding GCP Compliance & Quality Specialist and play a crucial role in ensuring the detailed execution of clinical trials. This is an outstanding opportunity to work in a world-class healthcare environment where your expertise will contribute to groundbreaking scientific advancements.
Role:
GCP Compliance Specialist
Location:
Remote, US
Job Responsibilities
Leads small to mid-sized process improvement initiatives, implementing sustainability and effectiveness strategies.
Proactively conducts risk assessments and supports mitigation planning for improvement projects.
Assists in updating and maintaining procedural documents.
Provides recommendations for increased efficiency and compliance through review of process documents and process maps.
Supports cross-functional teams in implementing process changes and ensuring adherence to best practices.
Contributes to training programs and process governance discussions.
Provides mentorship and guidance to developing team members.
Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise
Performs proactive as well as routine evaluation of clinical trial processes to determine adherence to process and procedural documentation through documentation review and active engagement with study team functional representatives
Helps develop and maintain KPIs, metrics and dashboards to track process quality and compliance
Provides near real-time feedback on study process and documentation quality as well as team performance and understanding on evaluated processes.
Represent GCP Compliance in meetings as needed.
Performs other duties as assigned.
Knowledge, Skills and Abilities:
Thorough understanding of procedural documents
Strong understanding of process improvement fundamentals
Solid investigative and analytical skills
Strong negotiation skills
Thorough understanding of clinical management technology and systems, and strong computer skills
Effective judgment, decision making, escalation, and risk management skills
Effective oral and written communication skills including the ability to communicate in English, both orally and in writing
Strong interpersonal skills and problem solving ability
Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting
Strong attention to detail
Thorough understanding of regulatory guidelines and directives
Strong creative and critical thinking skills
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Minimum of 4+ years clinical research experience in pharmaceutical or biotechnology field
Bachelor’s degree preferred
MUST HAVE experience working within a GCP Environment
Solid knowledge of and experience in GCP compliance, regulatory inspection readiness
Solid knowledge of drug development, GCP compliance processes
Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required
Solid knowledge of regulatory requirements governing clinical trial, industry best practices and related standard and documentation requirements
Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
Effectively resolve conflict in a constructive manner
Clinical research experience in all phases of clinical study life cycle, including start-up, interim and close-out, is preferred.
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Physical Requirements / Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to develop a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform optimally while balancing and prioritizing multiple projects or activities.
Benefits:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
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
Join Thermo Fisher Scientific Inc. as an outstanding GCP Compliance & Quality Specialist and play a crucial role in ensuring the detailed execution of clinical trials. This is an outstanding opportunity to work in a world-class healthcare environment where your expertise will contribute to groundbreaking scientific advancements.
Role:
GCP Compliance Specialist
Location:
Remote, US
Job Responsibilities
Leads small to mid-sized process improvement initiatives, implementing sustainability and effectiveness strategies.
Proactively conducts risk assessments and supports mitigation planning for improvement projects.
Assists in updating and maintaining procedural documents.
Provides recommendations for increased efficiency and compliance through review of process documents and process maps.
Supports cross-functional teams in implementing process changes and ensuring adherence to best practices.
Contributes to training programs and process governance discussions.
Provides mentorship and guidance to developing team members.
Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise
Performs proactive as well as routine evaluation of clinical trial processes to determine adherence to process and procedural documentation through documentation review and active engagement with study team functional representatives
Helps develop and maintain KPIs, metrics and dashboards to track process quality and compliance
Provides near real-time feedback on study process and documentation quality as well as team performance and understanding on evaluated processes.
Represent GCP Compliance in meetings as needed.
Performs other duties as assigned.
Knowledge, Skills and Abilities:
Thorough understanding of procedural documents
Strong understanding of process improvement fundamentals
Solid investigative and analytical skills
Strong negotiation skills
Thorough understanding of clinical management technology and systems, and strong computer skills
Effective judgment, decision making, escalation, and risk management skills
Effective oral and written communication skills including the ability to communicate in English, both orally and in writing
Strong interpersonal skills and problem solving ability
Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting
Strong attention to detail
Thorough understanding of regulatory guidelines and directives
Strong creative and critical thinking skills
Qualifications:
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Minimum of 4+ years clinical research experience in pharmaceutical or biotechnology field
Bachelor’s degree preferred
MUST HAVE experience working within a GCP Environment
Solid knowledge of and experience in GCP compliance, regulatory inspection readiness
Solid knowledge of drug development, GCP compliance processes
Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required
Solid knowledge of regulatory requirements governing clinical trial, industry best practices and related standard and documentation requirements
Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
Effectively resolve conflict in a constructive manner
Clinical research experience in all phases of clinical study life cycle, including start-up, interim and close-out, is preferred.
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Physical Requirements / Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to develop a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds.
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform optimally while balancing and prioritizing multiple projects or activities.
Benefits:
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
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.