Urwah Admin

Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company enables customers to make the world healthier, cleaner, and safer by supporting life sciences research, analytical challenges, laboratory productivity, diagnostics, and the development of therapies. Their global team offers innovative technologies and services through well-known brands, including Thermo Scientific and Applied Biosystems, among others.

<div>Work Schedule
Second Shift (Afternoons)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Warehouse
Job Description<div>
2nd Shift 03:00pm - 11:30pm
</div><div><div><div><div><div><div><div><div><div>Pay Range: $24-$26
<ul><li>As part of the Thermo Fisher Scientific team, you&rsquo;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&rsquo;s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.<h2 class="jobSectionHeader">
Location/Division Specific Information</h2>
Clinical Labeling Services, part of the Clinical Trials Division, located in Bohemia, New York provides leading clinical label design, production, and management services for the pharmaceutical and biotechnology industry. Our advanced inspection software, full in-house variable and non-variable print capabilities, and proprietary translation and regulatory approval system are designed to reduce overall clinical trial label cycle times.<h2 class="jobSectionHeader">
How Will You Make an Impact?:</h2>
The Equipment Operator plays a crucial part in ensuring smooth clinical label manufacturing processes within a team that is dynamic and fast-paced, relying on teamwork, multitasking, and communication. They are responsible for operating and maintaining equipment used in the production of clinical trial study labels directly impacting the efficiency and quality of the manufacturing processes.<h2 class="jobSectionHeader">
A Day in the Life:</h2>
Manufactures a wide array of label constructions using automated inkjet equipment following client-approved proofs and associated documentation to manufacture labels per established specifications.
Sets up computerization production runs and bulk transfer labels using the proprietary software application CLPS, as per department Standard Operating Procedures (SOPs) and Work Instructions (WIs) while monitoring all label production processing for accuracy and completeness by applying current Good Manufacturing Practices (cGMPs) in all areas of responsibility safely and efficiently.
Works independently in planning, setting up, and manufacturing a wide array of label constructions that meet client specifications while all equipment in the area of responsibility is maintained as per standard procedures and safety guidelines including keeping up with all current preventative maintenance practices and cleaning daily.<h1 class="jobSectionHeader">
Education:</h1>
High school diploma or equivalent required!<h1 class="jobSectionHeader">
Experience:</h1>
Required: Minimum of 2 years of work experience in a manufacturing, operations, production, lab setting or related fieldPreferred: Experience in a cGMP environment
Knowledge, Skills, Abilities:
Technical Skills: Printing or manufacturing experience with proficiency in computer operations of transferring data, MS excel and outlook, file management, are required.Mechanically inclined with the ability to accurately read measurements, troubleshoot issues and identify potential solutions associated with various label constructions; skills in performing roll splicing using manual equipment, and operating computerized digital inkjet equipment.Detail-oriented and the ability to work in an organized manner. Must be capable of handling confidential information and communicating in a professional manner with internal customers.<h2 class="jobSectionHeader">
Physical Requirements / Work Environment</h2>
Uses Personal Protective Equipment (PPE), and must be able to stand and move about including reaching, bending, stooping, grasping and understand chemical hygiene.Uses hand tools and equipment including forceful gripping, grasping, pushing, and pulling.Must lift and maneuver materials weighing up to 50 pounds maximum unassisted.<h2 class="jobSectionHeader">
What We Offer</h2>
Compensation
Competitive Hourly Pay Rate.Additional shift differential for 2nd shift and 3rd shift positions.Annual performance-based bonus.Annual merit performance-based increase.
Excellent Benefits
Benefits &amp; Total Rewards | Thermo Fisher ScientificMedical, Dental, &amp; Vision benefits-effective Day 1.Paid Time Off &amp; Designated Paid HolidaysRetirement Savings PlanTuition ReimbursementEmployee Referral BonusCareer Advancement Opportunities</li></ul></div></div></div></div></div></div></div></div></div>
Compensation and Benefits
The hourly pay range estimated for this position based in New York is $19.64&ndash;$29.45.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:<ul><li>
A choice of national medical and dental plans, and a national vision plan, including health incentive programs</li><li>
Employee assistance and family support programs, including commuter benefits and tuition reimbursement</li><li>
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy</li><li>
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan</li><li>
Employees&rsquo; Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount</li></ul>
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards</div>

Equipment Operator, Onsert - 2nd Shift

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Senior Manager, PPI
R-01359750
Sunnyvale, CA<div>
As part of the Thermo Fisher Scientific team, you&rsquo;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&rsquo;s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. 
 
Join our collaborative team as a Senior Staff PPI Business System Specialist and contribute to positive change across Thermo Fisher Scientific. You'll support our Practical Process Improvement (PPI) Business System, cultivating a culture of continuous improvement that directly impacts our mission of making the world healthier, cleaner, and safer. In this key role, you'll guide implementation of lean methodologies, develop and execute improvement initiatives, and partner with cross-functional teams to achieve measurable business results. 
 
Working with leadership teams across divisions, you'll support productivity initiatives, conduct PPI/LEAN training, and implement sustainable improvements that enhance customer service, financial performance, and quality standards. You'll utilize data-driven approaches to track KPIs, develop corrective action plans, and facilitate organizational development through lean management systems including daily management routines, Gemba walks, and various PPI/LEAN tools. 
 
Education/Experience: 
<ul><li>Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience managing continuous improvement programs across multi-site operations</li><li>Preferred Fields of Study: Engineering, Business, Operations, Computer Science, or related field</li><li>Six Sigma Black Belt certification required</li><li>Project Management certification preferred</li><li>Demonstrated expertise in lean methodologies, including Kaizen events, value stream mapping, and process optimization</li></ul></div><div>
Knowledge, Skills Abilities: 
<ul><li>Strong proficiency in developing and implementing tiered daily management systems and lean tools</li><li>Advanced knowledge of KPI development, tracking, and performance management</li><li>Demonstrated ability to collaborate with cross-functional teams in a matrix environment</li><li>Experience with data analytics and business intelligence tools (e.g., PowerBI, Excel)</li><li>Strong financial acumen and understanding of P&amp;L impact</li><li>Excellent presentation, facilitation, and communication skills</li><li>Demonstrated organizational development and leadership capabilities</li><li>Ability to develop and deliver effective training programs</li><li>Experience with Learning Management Systems and digital learning solutions</li><li>Proficiency in Microsoft Office suite and Power Platform tools</li><li>Travel may be required up to 25%</li><li>Experience in non-manufacturing environment preferred</li></ul></div>
Compensation and Benefits
The salary range estimated for this position based in California is $141,800.00&ndash;$212,675.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:<ul><li>
A choice of national medical and dental plans, and a national vision plan, including health incentive programs</li><li>
Employee assistance and family support programs, including commuter benefits and tuition reimbursement</li><li>
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy</li><li>
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan</li><li>
Employees&rsquo; Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount</li></ul>
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards</div>

Senior Manager, PPI

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you&rsquo;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&rsquo;s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Discover Impactful Work
Join Thermo Fisher Scientific in ensuring the highest quality standards across our operations. As a Quality Specialist III, you will support regulatory compliance and drive continuous improvement of quality systems that enable our customers to make the world healthier, cleaner, and safer.
You will collaborate with cross-functional teams to investigate quality issues, conduct audits, manage documentation, and implement corrective actions while fostering a culture of quality excellence throughout the organization. 
Location
This is a fully onsite role in Sunnyvale, CA with weekly travel to our San Jose, CA site. Relocation assistance is not provided.
A Day in the Life<ul><li>
Support and maintain compliance with GMP/GxP, ISO, and regulatory requirements</li><li>
Investigate quality issues and lead root cause analysis efforts</li><li>
Manage and support:<ul><li>
CAPA processes</li><li>
Deviations and nonconformances</li><li>
Change control activities</li></ul></li><li>
Conduct and support internal and external audits and regulatory inspections</li><li>
Author and review quality documentation (SOPs, investigation reports, etc.)</li><li>
Perform data analysis, trending, and reporting of quality metrics</li><li>
Collaborate with cross-functional teams to drive corrective and preventive actions</li><li>
Support continuous improvement initiatives and quality system enhancements</li></ul>
Keys to Success
Education
Bachelor&rsquo;s degree in Life Sciences, Engineering, Chemistry, Biology or related technical field with 5+ years of experience in quality assurance/quality control or Advanced degree with 3+ years of relevant experience
Experience:<ul><li>
Experience in regulated industries (pharmaceutical, medical device, or biotech preferred)</li><li>
Experience with quality management systems (TrackWise, Document Control Systems), CAPA processes, deviation management, and change control</li><li>
Demonstrated expertise in root cause analysis, investigation techniques, and corrective action implementation</li><li>
Experience conducting and hosting internal/external audits and regulatory inspections</li><li>
Proficiency in statistical analysis, data trending, and quality metrics reporting</li><li>
Project management experience preferred</li></ul>
Knowledge, Skills, Abilities<ul><li>
Strong knowledge of GMP/GxP regulations, ISO standards (9001/13485), and other relevant quality system requirements</li><li>
Knowledge of risk assessment methodologies and continuous improvement tools</li><li>
Strong technical writing skills for authoring SOPs, investigation reports, and other quality documentation</li><li>
Advanced problem-solving abilities and attention to detail</li><li>
Excellent verbal and written communication skills</li><li>
Strong interpersonal skills with ability to collaborate across functions and levels</li><li>
Ability to work in manufacturing environments with appropriate PPE as needed</li><li>
Ability to work independently and guide cross-functional teams</li><li>
May require up to 25% travel</li></ul>
Other:<ul><li>
Must be legally authorized to work in the United States without sponsorship now or in the future</li><li>
Must be able to pass a comprehensive background check and drug screen</li></ul>
Compensation and Benefits
The salary range estimated for this position based in California is $90,900.00&ndash;$122,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:<ul><li>
A choice of national medical and dental plans, and a national vision plan, including health incentive programs</li><li>
Employee assistance and family support programs, including commuter benefits and tuition reimbursement</li><li>
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy</li><li>
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan</li><li>
Employees&rsquo; Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount</li></ul>
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards</div>

Quality Specialist III

<div>Work Schedule
First Shift (Days)
Environmental Conditions
Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
As part of the Thermo Fisher Scientific team, you&rsquo;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&rsquo;s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
How will you make an impact?
The Quality Manager receives assignments in the form of site and functional objectives and determines how to deploy people, time, and resources to meet schedules, quality standards, and business goals. This role provides leadership and guidance to the Quality Control and Quality Assurance organizations within established company policies, recommends improvements to policies and procedures, and ensures effective execution of QC laboratory operations and QA systems. The Quality Manager is accountable for short- to mid-term (1&ndash;2 year) performance, compliance, and continuous improvement results for the quality function, with primary emphasis on QC laboratory excellence while maintaining robust QA systems and compliance.
What will you do?<ul><li>
Translate site and quality function objectives into actionable plans, priorities, and resource allocations to meet operational schedules and quality goals.</li><li>
Provide leadership and direction to the Quality Control team, managing through QC Supervisors as applicable, and ensuring alignment with site priorities.</li><li>
Ensure timely, compliant execution of QC testing, batch record review, and disposition of finished goods.</li><li>
Monitor quality performance metrics, identify trends, and take corrective actions to improve quality, efficiency, and reliability.</li><li>
Guide and support supervisors and individual contributors within established company policies, procedures, and quality systems.</li><li>
Recommend updates to QC and QA policies, procedures, and workflows and establish local procedures that impact the immediate organization.</li><li>
Manage the QA function to create a culture of quality awareness, teamwork, and compliance across the organization.</li><li>
Engage in daily oversight and guidance of nonconforming material investigations, complaint records, corrective and preventive actions, and change controls to drive timely and scientifically sound closure.</li><li>
Provide guidance and direction to stakeholders to ensure ISO 9001 compliance and Quality Management System adherence.</li><li>
Collaborate across functions and sites, leveraging quality and manufacturing expertise to troubleshoot problems, interpret data and determine next steps based on risk-based approach.</li><li>
Manage accuracy, completeness, and timeliness of Quality records.</li><li>
Lead external regulatory inspections and customer audits</li><li>
Oversee internal audits program.</li><li>
Develop quality talent through coaching, feedback, and performance management, with accountability for near-term capability needs, succession planning, and meeting personal career goals while achieving organization goals.</li><li>
Design, plan, and lead Practical Process Improvements (PPI) initiatives focusing on scientific practices, knowledge, best practice, standard work, or quality initiatives.</li></ul>
REQUIREMENTS
Education and Experience<ul><li>
Advanced degree plus 6 years of experience, or Bachelor's degree plus 8 years of experience in regulated pharmaceutical/biotech/medical device industry</li><li>
Preferred Fields of Study: Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, Biotechnology, Engineering, Microbiology, or related scientific field</li></ul><ul><li>
5+ years of people management experience leading QC laboratory teams</li><li>
Strong understanding of analytical testing methods and laboratory operations</li><li>
Knowledge of cGMP regulations, quality systems, and regulatory requirements preferred</li><li>
Demonstrated success implementing and improving quality systems and processes</li><li>
Experience with laboratory information management systems (LIMS) and data integrity requirements</li><li>
Experience leading conversations with customers and auditors and supporting regulatory inspections</li></ul>
Knowledge, Skills, Abilities<ul><li>
Proven understanding of Quality Control Laboratory operating principles and Quality Assurance procedures, processes, and guidelines</li><li>
Leadership experience developing and mentoring staff with ability to affect performance and development of individuals across the Quality department</li><li>
Ability to drive functional, technical, and operational excellence</li><li>
Ability to think strategically with the ability to direct the resolution of technical problems using innovative approaches</li><li>
Project management and organizational skills</li><li>
Clear written and verbal communication skills with ability to analyze data, summarize results, present data, and address feedback</li><li>
Practical application experience in continuous improvement methodologies to improve processes, strengthen quality, and drive efficiency</li><li>
Highly skilled in Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis</li></ul>
Compensation and Benefits
The salary range estimated for this position based in New Jersey is $112,500.00&ndash;$155,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:<ul><li>
A choice of national medical and dental plans, and a national vision plan, including health incentive programs</li><li>
Employee assistance and family support programs, including commuter benefits and tuition reimbursement</li><li>
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy</li><li>
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan</li><li>
Employees&rsquo; Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount</li></ul>
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards</div>

Quality Manager

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as an Medical Director/Sr Medical Director &ndash; Make an Impact at the Forefront of Innovation 
 
At Thermo Fisher Scientific, you&rsquo;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 &ndash; now and in the future. 
 
The Medical Director provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports ( e.g. PBRER, PSUR, DSUR) as well as other client deliverables (e.g. labeling reconciliation documents, CTD modules, REMS, RMP and CSR). 
 
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. 
 
What You'll Do: 
Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
General Support:<ul><li>
Ensure tasks delegated to PV are properly executed. Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Follow client SOPs/directives and project-specific WPDs for assigned projects. Comply with CRG&rsquo;s corporate policies and SOPs/WPDs.</li><li>
Provide medical consultation to team members and answer all study-related medical questions. Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.</li><li>
Provide therapeutic training and protocol training on assigned studies, as requested.</li><li>
Assist in writing (interpretation of safety and efficacy data) and/or reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure that the medical content is accurate and complete.</li></ul> 
Clinical Trial Support:<ul><li>
Monitor all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.</li><li>
Discuss all medical concerns with principal investigators and clients (e.g., interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in interpretation and decision-making regarding clinical situations as they relate to the investigational study.</li><li>
Provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes events reported by study sites.</li><li>
Perform data review as specified in the client contract and data validation manual, including review of coding listings and/or full safety data to assess potential safety concerns.</li></ul> 
Marketed Products Support:<ul><li>
Manage signal detection activities, scientifically review aggregate reports, contribute to label updates, and support dossier maintenance and risk management activities.</li><li>
Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted.</li></ul> 
Education and Experience Requirements:<ul><li>
MD or equivalent required. Active medical licensure preferred but not required.</li></ul> 
Candidates should have at least one of the following:<ul><li>
Clinical experience in treating patients in the specialty or sub-specialty (ie Cardiology residency/fellowship) associated with the applicants training (comparable to 2 years).</li><li>
Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry.</li><li>
Direct experience in safety/Pharmacovigilance (comparable to 2 years).</li></ul>
For Senior Medical Director: Candidates should have a combination of clinical experience and industry experience as follows:<ul><li>
Clinical experience in treating patients in the specialty or sub-specialty (ie Cardiology residency/fellowship) associated with the applicants training (comparable to 2 years) and one of the following:</li><li>
Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or</li><li>
Direct experience in safety/Pharmacovigilance (comparable to 2 years).</li></ul> 
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:<ul><li>
Therapeutic expertise across one or more medical specialty or sub-specialties</li><li>
Strong decision-making, problem solving, organizational skills and analytical skills</li><li>
Excellent oral and written communication skills</li><li>
Working knowledge of relevant safety databases (e.g. Medra)</li><li>
Flexibility to travel domestically and internationally</li><li>
Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information</li><li>
Proficiency in basic computer applications</li><li>
Fluent in spoken and written English</li><li>
Excellent interpersonal, influencing and team building skills</li><li>
Understanding guidelines (FDA, ICH, EMA and GCP)</li><li>
Working knowledge of biostatistics, data management, and clinical operations procedures</li><li>
Ability to act as a mentor/trainer to other staff within PV</li></ul> 
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.<ul><li>
Work is performed in an office environment with exposure to electrical office equipment.</li><li>
Occasional drives to site locations with occasional travel both domestic and international.</li></ul> 
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&rsquo;ll work in an environment where collaboration and development are part of the everyday experience&mdash;and where your contributions truly make a difference. 
 
Apply today to help us deliver tomorrow&rsquo;s breakthroughs.</div>

Medical Director/Sr Medical Director - Cardiology(Remote)

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Position Summary
This role supports LED site procurement through a hybrid buyer and PMO-focused position. The role includes tactical purchasing and supplier follow-up support, with a primary focus on building project structure, operating rhythm, visibility, and follow-through for Marietta procurement initiatives.
This role offers the opportunity to help shape a new procurement project support model for the site. The successful candidate will help define processes, build project tracking tools, establish reporting cadence, clarify ownership, surface risks, and support timely execution of procurement-led projects.
The role supports initiatives such as MCP, VAVE, NPI, supplier transitions, ECRs, material changes, supplier recovery, cost savings actions, and other site procurement projects. This position partners with site buyers, Category, IEC, Engineering, Quality, Supply Chain, Finance, Procurement Enablement, suppliers, and site leadership.
Key Responsibilities
PMO / Procurement Project Support<ul><li>
Build and maintain project cadence for assigned procurement initiatives, including status reviews, action tracking, escalation tracking, and leadership updates.</li><li>
Track project owners, actions, due dates, milestones, risks, blockers, next steps, and closure criteria.</li><li>
Convert approved opportunities or open issues into structured action plans with clear ownership, timing, deliverables, and escalation paths.</li><li>
Maintain project trackers, action logs, open-item lists, risk summaries, escalation summaries, and status reports.</li><li>
Follow up with buyers, suppliers, Engineering, Quality, Finance, Supply Chain, IEC, Category, and Procurement Enablement to confirm status and keep work moving.</li><li>
Maintain visibility to project inputs such as supplier quotes, lead times, cost impacts, inventory exposure, supplier readiness, documentation, implementation timing, and savings assumptions.</li><li>
Identify stalled actions, unclear ownership, missed dates, or execution barriers and escalate with clear facts and recommendations.</li><li>
Support project close-out by confirming implementation status, required documentation, savings timing, open risks, and handoff needs.</li></ul>
Buyer / Tactical Procurement Support<ul><li>
Support purchase order management in alignment with MRP demand, supplier lead times, and production needs.</li><li>
Monitor open orders, supplier commitments, shortage risks, recovery timing, and material availability concerns.</li><li>
Follow up with suppliers on late orders, confirmations, expedites, recovery plans, and routine purchasing issues.</li><li>
Communicate supply risks, recovery timing, and escalation needs to procurement leadership and cross-functional partners.</li><li>
Help resolve routine PO, invoice, pricing, receiving, quantity, and delivery discrepancies.</li><li>
Support buyers with supplier follow-up, data requests, quote follow-up, and project-related purchasing actions as needed.</li></ul>
Basic Qualifications<ul><li>
Associate degree in Supply Chain, Business, Operations, Engineering, Finance, Project Management, or related field; equivalent experience may be considered.</li><li>
Experience in purchasing, procurement, materials, supplier management, manufacturing support, project coordination, or related work.</li><li>
Experience with ERP/MRP systems, supplier communication, purchase order management, reporting, or action tracking.</li><li>
Strong communication, organization, problem-solving, and follow-through skills.</li></ul>
Preferred Qualifications<ul><li>
Experience in site procurement, PMO support, MCP, VAVE, NPI, ECR tracking, supplier recovery, supplier transition, or product transfer activity.</li><li>
Experience building or improving project cadence, report-outs, action logs, trackers, escalation processes, or status-reporting tools.</li><li>
Proficiency with Microsoft Excel, procurement reporting tools, project trackers, action logs, and status reporting.</li></ul></div>

Buyer III, Procurement Project Execution

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description<div>
Join Us as a Clinical Research Associate (Level I/II) &ndash; 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&rsquo;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&rsquo;ll Do: 
<ul><li>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.</li><li>Participates in investigator meetings as necessary. Identifies potential</li><li>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.</li><li>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.</li><li>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).</li><li>Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.</li><li>Responds to company, client and applicable regulatory requirements/audits/inspections.</li><li>Maintains &amp; completes administrative tasks such as expense reports and timesheets in a timely manner.</li><li>Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.</li><li>Contributes to other project work and initiatives for process improvement, as required.</li></ul> 
Education and Experience Requirements: 
<ul><li>Bachelor's degree in a life science related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.</li></ul></div><ul><li>
Total experience: at least 3 years as a CRA</li><li>
Oncology experience: at least 2 years of on-site, hands-on experience</li><li>
Location: central Poland</li></ul><div><ul><li> 
Valid driver's license where applicable.</li></ul> 
Knowledge, Skills and Abilities: 
<ul><li>Proven clinical monitoring skills</li><li>Demonstrated understanding of medical/therapeutic area knowledge and medical terminology</li><li>Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents</li><li>Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving</li><li>Ability to manage Risk Based Monitoring concepts and processes</li><li>Good oral and written communication skills, with the ability to communicate effectively with medical personnel</li><li>Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers&rsquo; underlying issues</li><li>Good organizational and time management skills</li><li>Effective interpersonal skills</li><li>Attention to detail</li><li>Ability to remain flexibile and adaptable in a wide range of scenarios</li><li>Ability to work in a team or independently as required</li><li>Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software</li><li>Good English language and grammar skills</li><li>Good presentation skills</li></ul> 
Working Conditions and Environment: 
<ul><li>Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.</li><li>Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.</li><li>Exposure to biological fluids with potential exposure to infectious organisms.</li><li>Personal protective equipment required such as protective eyewear, garments and gloves.</li><li>Exposure to fluctuating and/or extreme temperatures on rare occasions</li></ul></div></div>

CRA I/II - FSP - EMEA

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