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via LinkedIn
posted_at: 2 days agoschedule_type: Full-time
Quality Technician - Batteries / Li-ion / Lithium Ion / Quality Assurance / Product Validation / Process Validation / Battery
By offering a simpler, more dependable, and safer manufacturing method, my client is rethinking the production of lithium-ion cells. This will speed up production while lowering the cost of current and next-generation cell technology...
Responsibilities:
• Establish, carry out, and develop campaign validation. Audit the
Quality Technician - Batteries / Li-ion / Lithium Ion / Quality Assurance / Product Validation / Process Validation / Battery
By offering a simpler, more dependable, and safer manufacturing method, my client is rethinking the production of lithium-ion cells. This will speed up production while lowering the cost of current and next-generation cell technology...
Responsibilities:
• Establish, carry out, and develop campaign validation. Audit the production line to ensure proper configuration.
• Identify technical escalation risks and oversee root cause investigations for important production issues.
• Define, carry out, and supervise actions for verification and validation linked to line changes
Qualifications
• Minimum Bachelor’s Degree in technical field Chemistry, Material Science, Mechanical Engineering or related field preferred.
• 2-4 years of experience in Quality Engineering in a manufacturing environment
• Battery industry experience a plus but is not required
If you are looking for an opportunity to work with a company who have made market-changing improvements to the battery industry please apply or send your CV to ww@eu-recruit.com
#Battery #Batteries #Liion #LithiumIon #QualityAssurance #QualityEngineering #ProductValidation #ProcessValidation #Safety #Manufacturing
By applying to this role you understand that we may collect your personal data and store and process it on our systems. For more information please see our Privacy Notice (https://eu-recruit.com/about-us/privacy-notice Show more details...
By offering a simpler, more dependable, and safer manufacturing method, my client is rethinking the production of lithium-ion cells. This will speed up production while lowering the cost of current and next-generation cell technology...
Responsibilities:
• Establish, carry out, and develop campaign validation. Audit the production line to ensure proper configuration.
• Identify technical escalation risks and oversee root cause investigations for important production issues.
• Define, carry out, and supervise actions for verification and validation linked to line changes
Qualifications
• Minimum Bachelor’s Degree in technical field Chemistry, Material Science, Mechanical Engineering or related field preferred.
• 2-4 years of experience in Quality Engineering in a manufacturing environment
• Battery industry experience a plus but is not required
If you are looking for an opportunity to work with a company who have made market-changing improvements to the battery industry please apply or send your CV to ww@eu-recruit.com
#Battery #Batteries #Liion #LithiumIon #QualityAssurance #QualityEngineering #ProductValidation #ProcessValidation #Safety #Manufacturing
By applying to this role you understand that we may collect your personal data and store and process it on our systems. For more information please see our Privacy Notice (https://eu-recruit.com/about-us/privacy-notice Show more details...
via LinkedIn
posted_at: 2 days agoschedule_type: Full-time
Senior Process Engineer – Mid End
The platform and manufacturing method for lithium-ion cells are being revolutionized by my client to address the major issues for a better energy future. They offer a simpler, more dependable, safer manufacturing method that speeds up production while cutting the prices of current and next-generation cell technology...
Responsibilities:
• Develop novel manufacturing processes that contribute to the establishment
Senior Process Engineer – Mid End
The platform and manufacturing method for lithium-ion cells are being revolutionized by my client to address the major issues for a better energy future. They offer a simpler, more dependable, safer manufacturing method that speeds up production while cutting the prices of current and next-generation cell technology...
Responsibilities:
• Develop novel manufacturing processes that contribute to the establishment of our high-volume production system.
• Characterize and develop a deep understanding of critical material performance in the processes through experimentation and analysis.
• Perform equipment and process capability studies and make improvements based on those data-driven results.
Required Skills and Experience:
• Knowledge of coating technologies.
• Knowledge of various laminating technologies, including, heat sealing, adhesive sealing, etc.
• Experience with slitting, die cutting, roll-to-roll processes, intermittent motion processes, and vacuum lamination.
• Experience with in-line continuous vision system inspection systems.
• At least 4-6 years of experience in a wide range of manufacturing processes.
Key Words: Process Engineer / Die Cutting / Laminating / Heat Sealing / Adhesive Sealing / Slitting / Vacuum Lamination
You will need to be based in the USA to be considered for this position, have US citizenship, green card holder, or H1B transfer.
I can also be contacted at ww@eu-recruit.com, to provide full details, arrange an application, or answer any questions you might have.
#ProcessEngineer #DieCutting #VacuumLamination #HeatSealing #AdhesiveSealing #Lamination #Slitting
By applying to this role you understand that we may collect your personal data and store and process it on our systems. For more information please see our Privacy Notice (https://eu-recruit.com/about-us/privacy-notice Show more details...
The platform and manufacturing method for lithium-ion cells are being revolutionized by my client to address the major issues for a better energy future. They offer a simpler, more dependable, safer manufacturing method that speeds up production while cutting the prices of current and next-generation cell technology...
Responsibilities:
• Develop novel manufacturing processes that contribute to the establishment of our high-volume production system.
• Characterize and develop a deep understanding of critical material performance in the processes through experimentation and analysis.
• Perform equipment and process capability studies and make improvements based on those data-driven results.
Required Skills and Experience:
• Knowledge of coating technologies.
• Knowledge of various laminating technologies, including, heat sealing, adhesive sealing, etc.
• Experience with slitting, die cutting, roll-to-roll processes, intermittent motion processes, and vacuum lamination.
• Experience with in-line continuous vision system inspection systems.
• At least 4-6 years of experience in a wide range of manufacturing processes.
Key Words: Process Engineer / Die Cutting / Laminating / Heat Sealing / Adhesive Sealing / Slitting / Vacuum Lamination
You will need to be based in the USA to be considered for this position, have US citizenship, green card holder, or H1B transfer.
I can also be contacted at ww@eu-recruit.com, to provide full details, arrange an application, or answer any questions you might have.
#ProcessEngineer #DieCutting #VacuumLamination #HeatSealing #AdhesiveSealing #Lamination #Slitting
By applying to this role you understand that we may collect your personal data and store and process it on our systems. For more information please see our Privacy Notice (https://eu-recruit.com/about-us/privacy-notice Show more details...
via LinkedIn
posted_at: 8 days agoschedule_type: Full-time
Make a greater impact on lives through a digitally-enabled enterprise
We are working towards our aspiration of shaping the future of Pharma. Backed by investment at every step, we harness the latest technology, data, and innovative ways of working to introduce new approaches that put Digital at AstraZeneca’s heart...
Be part of a chapter that’s still being written. Trusted and empowered to change the way things are done, with the tools and support
Make a greater impact on lives through a digitally-enabled enterprise
We are working towards our aspiration of shaping the future of Pharma. Backed by investment at every step, we harness the latest technology, data, and innovative ways of working to introduce new approaches that put Digital at AstraZeneca’s heart...
Be part of a chapter that’s still being written. Trusted and empowered to change the way things are done, with the tools and support to get you there. Here we are free to unleash our curiosity and turn thinking into reality where smart risks and quick decisions come together to power disruption and innovation.
Office Locations: This is an on-site - office-based, global role. Please consider the following AZ HUB locations – Cambridge, UK - Madrid, Spain – Gothenburg, Sweden – Milan, Italy – Hamburg, DE.
Role and Responsibilities:
The Director, of Commercial Data Sciences & AI - European Union is a key leader in the Commercial Data Science & AI team whose mission is to take a patient-centric, data-driven approach to personalize and transform healthcare delivery to the millions of patients along with a multi-disciplinary team of physicians who care for them. This responsibility involves working closely with cross-functional Science, Medical, and Business leaders to identify, prioritize, and develop Data Science, AI, and Advanced Analytics Platform & Products across AZ Oncology and Bio-pharma Business
The scope of this role is Global with a focus on EU markets where AstraZeneca’s life-changing medicines are approved to help patients live longer and realize AZ’s bold ambition of eliminating Cancer as a cause of death.
YOUR MAIN ACCOUNTABILITIES AND TASKS:
• Collaborate across the AstraZeneca Data and AI community to develop best practices and cross-functional opportunities that drive value
• Oversight of partnerships with multiple third parties, academic or outsourced partners to shape and drive project outcomes and knowledge building
• Own and lead Data Science & AI products per Cancer tumor type and /or Biopharma disease area. Product features include
• Development of ML Models & Classifiers for a deeper understanding of the patient journey
• Development of Predictive ML models around patient disease progression, Adverse events, and other outcomes
• Own and lead the development of ML models using unstructured notes, Scientific, Clinical documents, and Research publications
• Own and lead the development of Personalized ML models around the dissemination of Scientific, Medical content and messages across Physical & Digital Channels in a coordinated manner for the best patient outcomes
• These products include the application of specialized approaches in classification, regression, clustering, NLP, image analysis, deep learning, knowledge graphs, and/or other advanced techniques.
• Using domain-specific understanding, translate unstructured, complex business problems into the appropriate data problem, models, and analytical solutions across multiple disease areas
• Develop effective relationships with EU commercial and medical leaders to ensure the utilization and value of information resources
• Responsible for Evangelizing & Applying advanced data science capabilities across multiple cross-business teams, including Sales, Marketing, Medical, and Market Access that drive value to AstraZeneca Commercial Business
• Lead and apply ongoing knowledge and awareness in trends, standard methodology, and new developments in data science to influence functional practices.
Your Education & Experience
Minimum Qualifications:
• Bachelor’s Degree plus 5-7 years of progressive professional work experience in mathematics, computer science, engineering, physics, statistics, economics, computational sciences, or a quantitative discipline. * 7+ years of qualified professional experience can be substituted for Bachelor’s degree
• Documented track record of Developing Data Science and AI products that have generated business value, and impact across multiple Industries
• In-depth experience with modern data science approaches, including unsupervised and supervised classification and regression algorithms such as k-means clustering, support vector machines, random forests, neural networks, and deep learning. May also have expertise in advanced statistical modeling or broader aspects of applied mathematics such as dynamic systems or optimization
• Experience in the modeling of complex datasets in applied business and/or scientific application domains
• Advanced software development skills in at least two of the standard data science languages (such as R, Julia, or Python) and familiarity with database systems (e.g. SQL, NoSQL, graph)
• In-depth experience in manipulating and analyzing large high dimensionality unstructured datasets, drawing conclusions, defining recommended actions, and reporting results across stakeholders
• Understanding of algorithm design, development, optimization, scaling, and applications
• Excellent written and verbal communication, business analysis, and consultancy skills with stakeholders and colleagues
Preferred Qualifications:
• Advanced degree plus 3 - 5 years of progressive professional work experience in mathematics, computer science, engineering, physics, statistics, economics, or a quantitative discipline.
• Previous work experience in high-performance computing or cloud environment
• Documented track record of publishing relevant predictive modeling results and tools in peer-reviewed journals, conferences, and other scientific proceedings.
• Prior experience in understanding biomedical data sets and real-world data sets relevant to life sciences and healthcare
• Knowledge of novel methods of development and application
• Familiarity with navigating a complex global organization
• Prior people management experience in recruiting, leading, and mentoring Data Science and Machine learning Engineers
• Track record of success in influencing and controlling budgets
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience -- it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.
Where can I find out more?
• Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en Show more details...
We are working towards our aspiration of shaping the future of Pharma. Backed by investment at every step, we harness the latest technology, data, and innovative ways of working to introduce new approaches that put Digital at AstraZeneca’s heart...
Be part of a chapter that’s still being written. Trusted and empowered to change the way things are done, with the tools and support to get you there. Here we are free to unleash our curiosity and turn thinking into reality where smart risks and quick decisions come together to power disruption and innovation.
Office Locations: This is an on-site - office-based, global role. Please consider the following AZ HUB locations – Cambridge, UK - Madrid, Spain – Gothenburg, Sweden – Milan, Italy – Hamburg, DE.
Role and Responsibilities:
The Director, of Commercial Data Sciences & AI - European Union is a key leader in the Commercial Data Science & AI team whose mission is to take a patient-centric, data-driven approach to personalize and transform healthcare delivery to the millions of patients along with a multi-disciplinary team of physicians who care for them. This responsibility involves working closely with cross-functional Science, Medical, and Business leaders to identify, prioritize, and develop Data Science, AI, and Advanced Analytics Platform & Products across AZ Oncology and Bio-pharma Business
The scope of this role is Global with a focus on EU markets where AstraZeneca’s life-changing medicines are approved to help patients live longer and realize AZ’s bold ambition of eliminating Cancer as a cause of death.
YOUR MAIN ACCOUNTABILITIES AND TASKS:
• Collaborate across the AstraZeneca Data and AI community to develop best practices and cross-functional opportunities that drive value
• Oversight of partnerships with multiple third parties, academic or outsourced partners to shape and drive project outcomes and knowledge building
• Own and lead Data Science & AI products per Cancer tumor type and /or Biopharma disease area. Product features include
• Development of ML Models & Classifiers for a deeper understanding of the patient journey
• Development of Predictive ML models around patient disease progression, Adverse events, and other outcomes
• Own and lead the development of ML models using unstructured notes, Scientific, Clinical documents, and Research publications
• Own and lead the development of Personalized ML models around the dissemination of Scientific, Medical content and messages across Physical & Digital Channels in a coordinated manner for the best patient outcomes
• These products include the application of specialized approaches in classification, regression, clustering, NLP, image analysis, deep learning, knowledge graphs, and/or other advanced techniques.
• Using domain-specific understanding, translate unstructured, complex business problems into the appropriate data problem, models, and analytical solutions across multiple disease areas
• Develop effective relationships with EU commercial and medical leaders to ensure the utilization and value of information resources
• Responsible for Evangelizing & Applying advanced data science capabilities across multiple cross-business teams, including Sales, Marketing, Medical, and Market Access that drive value to AstraZeneca Commercial Business
• Lead and apply ongoing knowledge and awareness in trends, standard methodology, and new developments in data science to influence functional practices.
Your Education & Experience
Minimum Qualifications:
• Bachelor’s Degree plus 5-7 years of progressive professional work experience in mathematics, computer science, engineering, physics, statistics, economics, computational sciences, or a quantitative discipline. * 7+ years of qualified professional experience can be substituted for Bachelor’s degree
• Documented track record of Developing Data Science and AI products that have generated business value, and impact across multiple Industries
• In-depth experience with modern data science approaches, including unsupervised and supervised classification and regression algorithms such as k-means clustering, support vector machines, random forests, neural networks, and deep learning. May also have expertise in advanced statistical modeling or broader aspects of applied mathematics such as dynamic systems or optimization
• Experience in the modeling of complex datasets in applied business and/or scientific application domains
• Advanced software development skills in at least two of the standard data science languages (such as R, Julia, or Python) and familiarity with database systems (e.g. SQL, NoSQL, graph)
• In-depth experience in manipulating and analyzing large high dimensionality unstructured datasets, drawing conclusions, defining recommended actions, and reporting results across stakeholders
• Understanding of algorithm design, development, optimization, scaling, and applications
• Excellent written and verbal communication, business analysis, and consultancy skills with stakeholders and colleagues
Preferred Qualifications:
• Advanced degree plus 3 - 5 years of progressive professional work experience in mathematics, computer science, engineering, physics, statistics, economics, or a quantitative discipline.
• Previous work experience in high-performance computing or cloud environment
• Documented track record of publishing relevant predictive modeling results and tools in peer-reviewed journals, conferences, and other scientific proceedings.
• Prior experience in understanding biomedical data sets and real-world data sets relevant to life sciences and healthcare
• Knowledge of novel methods of development and application
• Familiarity with navigating a complex global organization
• Prior people management experience in recruiting, leading, and mentoring Data Science and Machine learning Engineers
• Track record of success in influencing and controlling budgets
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience -- it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.
Where can I find out more?
• Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en Show more details...
via Salary.com
schedule_type: Full-time
Hybrid Model: 2 Days WFH (once fully trained) and 3 days based in EU Automation's office, located in Elk Grove Village, IL 60007
About EU Automation...
Our aim is to 'Make Manufacturing Possible' by delivering fast, quality, cost effective solutions to our customers worldwide.
Machines break and downtime can cost companies millions in lost revenue. EU Automation has access to a global supply of automation parts at our fingertips, ensuring that
Hybrid Model: 2 Days WFH (once fully trained) and 3 days based in EU Automation's office, located in Elk Grove Village, IL 60007
About EU Automation...
Our aim is to 'Make Manufacturing Possible' by delivering fast, quality, cost effective solutions to our customers worldwide.
Machines break and downtime can cost companies millions in lost revenue. EU Automation has access to a global supply of automation parts at our fingertips, ensuring that manufacturers across the world can avoid unnecessary downtime.
EU Automation now employs over 250 people in the UK, Germany, USA and Singapore and is proud of being named as a Sunday Times Fast Track 100, Profit Track and HSBC International Fast Track Company. Being part of EU Automation at this period of growth is extremely exciting and challenging as we strive as a team to be the best in our industry.
Responsibilities:
• Liaising with sales, purchasing, customer service, logistics and finance
to make sure import / export documentation (commercial invoice, certificate of origin, EUR1 etc) are raised in an appropriate and timely manner.
• Liaising with carriers and freight agent to obtain freight quotes and book
shipments using the correct incoterms.
• Tracking and updating shipment status on a daily basis.
• Preparing import clearing instructions for customs brokers and checking
import entry to ensure duty / taxes are paid correctly.
• Uploading data into systems where required, with accuracy ensuring
attention to detail.
• Ensuring up to date knowledge of legislative requirements.
• Inputting and maintaining data sheets both internally and externally.
• Checking and releasing invoices for both freight cost and customs fees
to accounts department for payment. Disputing discrepancies with carriers and freight agents for refund / credit note.
• Calculating and allocating freight cost / customs charges to jobs
appropriately.
• Making claims with carriers for shipments lost or damaged during transit.
Key Skills:
• Experience in global freight, trade compliance and customs formalities.
• Effective communicator, with a good telephone manner and customer
service skills.
• Microsoft Office knowledge.
• Ability to work both independently and as part of a busy team.
• Willing to train for further qualifications where appropriate.
• Experience in brokerage with fast parcel operators (DHL, UPS or Fedex)
preferred.
Benefits:
• Health Insurance
• Dental & Vision
• 401k Plan
• 20 days PTO
• 2 days a week work from home (once fully trained)
Job Type: Full-time
Salary: $40,000.00 - $50,000.00 per year
Benefits:
• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance
Schedule:
• Monday to Friday
Work Location: One location Show more details...
About EU Automation...
Our aim is to 'Make Manufacturing Possible' by delivering fast, quality, cost effective solutions to our customers worldwide.
Machines break and downtime can cost companies millions in lost revenue. EU Automation has access to a global supply of automation parts at our fingertips, ensuring that manufacturers across the world can avoid unnecessary downtime.
EU Automation now employs over 250 people in the UK, Germany, USA and Singapore and is proud of being named as a Sunday Times Fast Track 100, Profit Track and HSBC International Fast Track Company. Being part of EU Automation at this period of growth is extremely exciting and challenging as we strive as a team to be the best in our industry.
Responsibilities:
• Liaising with sales, purchasing, customer service, logistics and finance
to make sure import / export documentation (commercial invoice, certificate of origin, EUR1 etc) are raised in an appropriate and timely manner.
• Liaising with carriers and freight agent to obtain freight quotes and book
shipments using the correct incoterms.
• Tracking and updating shipment status on a daily basis.
• Preparing import clearing instructions for customs brokers and checking
import entry to ensure duty / taxes are paid correctly.
• Uploading data into systems where required, with accuracy ensuring
attention to detail.
• Ensuring up to date knowledge of legislative requirements.
• Inputting and maintaining data sheets both internally and externally.
• Checking and releasing invoices for both freight cost and customs fees
to accounts department for payment. Disputing discrepancies with carriers and freight agents for refund / credit note.
• Calculating and allocating freight cost / customs charges to jobs
appropriately.
• Making claims with carriers for shipments lost or damaged during transit.
Key Skills:
• Experience in global freight, trade compliance and customs formalities.
• Effective communicator, with a good telephone manner and customer
service skills.
• Microsoft Office knowledge.
• Ability to work both independently and as part of a busy team.
• Willing to train for further qualifications where appropriate.
• Experience in brokerage with fast parcel operators (DHL, UPS or Fedex)
preferred.
Benefits:
• Health Insurance
• Dental & Vision
• 401k Plan
• 20 days PTO
• 2 days a week work from home (once fully trained)
Job Type: Full-time
Salary: $40,000.00 - $50,000.00 per year
Benefits:
• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance
Schedule:
• Monday to Friday
Work Location: One location Show more details...
via Indeed
schedule_type: Full-time
ER Bonus:
$5,000...
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Specialist of Regulatory Affairs. The Regulatory Affairs Senior Specialist is responsible for supporting MDR device registration efforts in the European Union (EU) for new product development efforts as well as evaluating and reporting product changes to existing
ER Bonus:
$5,000...
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Specialist of Regulatory Affairs. The Regulatory Affairs Senior Specialist is responsible for supporting MDR device registration efforts in the European Union (EU) for new product development efforts as well as evaluating and reporting product changes to existing products in the most efficient, compliant manner. In coordination with Regulatory Affairs management, this role will assist in the development of regulatory strategy, manage the execution of regulatory plans, and perform other activities that lead to and maintain device registrations for Arthrex’s medical devices. This position is based out of the Arthrex headquarters in Naples, Florida. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™.
We would like this position to sit with us in our Corporate Headquarters in Naples to work directly with the team with a partial-flexible WFH policy. Generous relocation package offered!
Duties and Responsibilities:
Creates/updates technical documentation to achieve and maintain MDR certification.
Develops implementation plans for the preparation and submission of new products for the EU market.
Advises project teams on pre-market regulatory requirements, such as documentation and testing needed, labeling requirements, or clinical study compliance issues.
Provides project teams with on-going support to resolve any real or perceived regulatory issues.
Determines the regulatory impact of proposed product changes on EU registrations.
Coordinate the review of MDR submissions in accordance with established project timelines.
Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
Requirements:
5 years relevant experience required preferably in a regulatory affairs role in the life science industry.
Bachelor’s degree required, engineering or science discipline preferred.
Advanced degree preferred.
Orthopedic medical device experience preferred.
Regulatory Affairs Certification (RAC) preferred.
Regulatory submission experience with the EU MDR or MDD is required.
Project management experience is required.
Exceptional written and oral communication skills required.
Advanced knowledge of regulatory framework and regulatory requirements for EU MDR.
Intermediate knowledge of product life-cycle, product development process, design control and change control.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of writings, technical instructions in mathematical or diagram form, communications, and deal with several abstract and concrete variables.
Mathematical Skills
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skills:
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
Arthrex 2023 Benefits
Medical, Dental and Vision Insurance
Company-Provided Life Insurance
Voluntary Life Insurance
Flexible Spending Account (FSA)
Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
Matching 401(k) Retirement Plan
Annual Bonus
Wellness Incentive Program
Free Onsite Medical Clinics
Free Onsite Lunch
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Provider (EAP)
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Nearest Major Market: Naples Show more details...
$5,000...
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Senior Specialist of Regulatory Affairs. The Regulatory Affairs Senior Specialist is responsible for supporting MDR device registration efforts in the European Union (EU) for new product development efforts as well as evaluating and reporting product changes to existing products in the most efficient, compliant manner. In coordination with Regulatory Affairs management, this role will assist in the development of regulatory strategy, manage the execution of regulatory plans, and perform other activities that lead to and maintain device registrations for Arthrex’s medical devices. This position is based out of the Arthrex headquarters in Naples, Florida. Join our talented team at a growing global medical device company focused on Helping Surgeons Treat Their Patients Better™.
We would like this position to sit with us in our Corporate Headquarters in Naples to work directly with the team with a partial-flexible WFH policy. Generous relocation package offered!
Duties and Responsibilities:
Creates/updates technical documentation to achieve and maintain MDR certification.
Develops implementation plans for the preparation and submission of new products for the EU market.
Advises project teams on pre-market regulatory requirements, such as documentation and testing needed, labeling requirements, or clinical study compliance issues.
Provides project teams with on-going support to resolve any real or perceived regulatory issues.
Determines the regulatory impact of proposed product changes on EU registrations.
Coordinate the review of MDR submissions in accordance with established project timelines.
Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
Requirements:
5 years relevant experience required preferably in a regulatory affairs role in the life science industry.
Bachelor’s degree required, engineering or science discipline preferred.
Advanced degree preferred.
Orthopedic medical device experience preferred.
Regulatory Affairs Certification (RAC) preferred.
Regulatory submission experience with the EU MDR or MDD is required.
Project management experience is required.
Exceptional written and oral communication skills required.
Advanced knowledge of regulatory framework and regulatory requirements for EU MDR.
Intermediate knowledge of product life-cycle, product development process, design control and change control.
Reasoning Ability:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of writings, technical instructions in mathematical or diagram form, communications, and deal with several abstract and concrete variables.
Mathematical Skills
Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
Language and Communication Skills:
Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.
Arthrex 2023 Benefits
Medical, Dental and Vision Insurance
Company-Provided Life Insurance
Voluntary Life Insurance
Flexible Spending Account (FSA)
Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
Matching 401(k) Retirement Plan
Annual Bonus
Wellness Incentive Program
Free Onsite Medical Clinics
Free Onsite Lunch
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Provider (EAP)
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Nearest Major Market: Naples Show more details...
via Greenhouse
schedule_type: Full-time
Scale is seeking an experienced Account Executive to lead growth and impact from Scales products. Scale is an AI infrastructure platform that empowers machine learning developers and organizations to build the world’s most ambitious AI solutions. As part of the leadership team in GTM, you will oversee a customer segment, drive pipeline, and close deals within this customer segment. The Who, What... Where and Why
Who?
• As an Account Executive,
Scale is seeking an experienced Account Executive to lead growth and impact from Scales products. Scale is an AI infrastructure platform that empowers machine learning developers and organizations to build the world’s most ambitious AI solutions. As part of the leadership team in GTM, you will oversee a customer segment, drive pipeline, and close deals within this customer segment. The Who, What... Where and Why
Who?
• As an Account Executive, you have experience in:
• Impact led business growth: Expertise in selling to digital first companies and can use and adopt technologies to build a better world. Experience defining requirements and building strategies to effectively scale revenue through early product development, and leading teams focused on impact as well as revenue.
• Comfortable in ambiguous environments: You are going to be working on selling products very early in development, iterating on those sales models, and closing marquee customers for our new products.
• +2 years of Solution Sales experience and a track record of personally selling and closing complex solutions to enterprise and software companies.
• Technology sales: Expertise in technology sales, distribution, and adoption of complex business models. Scale isn’t a “revenue per seat” sales model. We focus on developer / API focussed technologies, or consumption based technology. Selling to machine learning and data science teams. Having this experience is a plus, but not required. At Scale, customer relationships are dependent on technical performance.
• Executive customer engagement: Proven track record of successfully building and expanding customer relationships to new departments and c-suite.
• Cross functional and executive influence: Working cross functionally with Executive Leadership, Product, Marketing, Legal, Finance, Operations, and Compliance to ensure customer success. Demonstrated ability to develop strong consultative relationships with external partners and internal cross-functional teams at all levels. Experience with creating, developing, and communicating executive level materials.
• Accountability: Quantifying business needs and developing metrics. Proven track record of delivering performance against goals consistently and predictably.
What?
• You’ll own Scale’s execution for driving impact through customer growth and success. In this highly visible role, you will own business plans and drive impact from one of our highest growth segments within Scale.
• Ideally, you also have experience selling both to a business and technical audience.
• Demonstrated success by achieving quota on a consistent basis.
• Ability to drive the sales process from internal leads to qualifying new prospects and managing deals to closure.
• Passionate about what you do and you are able to think outside of the box.
• Forecast opportunities, drive accountability cross functionally, and most importantly CLOSE DEALS!
• Strong sales process skills, you are not afraid of entering details into Salesforce; building dashboards for yourself to manage your team and focusing individuals to capture opportunity data to properly report against.
Why?
• This role will be part of the sales team of Scale in the Automotive Pod, led by our VP Automotive Business. You will be a part of a high-growth sales team defining the future of AI infrastructure for customers.
• It should be noted that is an opportunity to have impact not just on revenue, but cross functionally within Scale. As we are a new company and building these functions for the first time, it is an opportunity to leave your legacy on an already high growth company.
Where?
• This position is to be remote in the E.U. with a preference on Germany. No matter where you are based, you will experience a company that believes in small teams for maximum impact; seeks well-rounded talent to ensure a full perspective on our customers’ experience, understands that this is a marathon, not a sprint; that continuously and purposefully builds an inclusive culture that empowers everyone to do their best work and be the best version of themselves. Languages: English = must, German = must, other languages advantageous.
Sales Commission:
• Additionally, this role is eligible to earn commissions.
The base salary range for this full-time position in our hub locations of San Francisco, New York, Seattle and DC is $140,000.00 - $175,000.00. Compensation packages at Scale include base salary and benefits. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position, determined by work location and additional factors, including job-related skills, experience, interview performance, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. You’ll also receive benefits including, but not limited to: Comprehensive health, dental and vision coverage, retirement benefits, a learning and development stipend, and generous PTO. Additionally, this role may be eligible for additional benefits such as a commuter stipend Show more details...
Who?
• As an Account Executive, you have experience in:
• Impact led business growth: Expertise in selling to digital first companies and can use and adopt technologies to build a better world. Experience defining requirements and building strategies to effectively scale revenue through early product development, and leading teams focused on impact as well as revenue.
• Comfortable in ambiguous environments: You are going to be working on selling products very early in development, iterating on those sales models, and closing marquee customers for our new products.
• +2 years of Solution Sales experience and a track record of personally selling and closing complex solutions to enterprise and software companies.
• Technology sales: Expertise in technology sales, distribution, and adoption of complex business models. Scale isn’t a “revenue per seat” sales model. We focus on developer / API focussed technologies, or consumption based technology. Selling to machine learning and data science teams. Having this experience is a plus, but not required. At Scale, customer relationships are dependent on technical performance.
• Executive customer engagement: Proven track record of successfully building and expanding customer relationships to new departments and c-suite.
• Cross functional and executive influence: Working cross functionally with Executive Leadership, Product, Marketing, Legal, Finance, Operations, and Compliance to ensure customer success. Demonstrated ability to develop strong consultative relationships with external partners and internal cross-functional teams at all levels. Experience with creating, developing, and communicating executive level materials.
• Accountability: Quantifying business needs and developing metrics. Proven track record of delivering performance against goals consistently and predictably.
What?
• You’ll own Scale’s execution for driving impact through customer growth and success. In this highly visible role, you will own business plans and drive impact from one of our highest growth segments within Scale.
• Ideally, you also have experience selling both to a business and technical audience.
• Demonstrated success by achieving quota on a consistent basis.
• Ability to drive the sales process from internal leads to qualifying new prospects and managing deals to closure.
• Passionate about what you do and you are able to think outside of the box.
• Forecast opportunities, drive accountability cross functionally, and most importantly CLOSE DEALS!
• Strong sales process skills, you are not afraid of entering details into Salesforce; building dashboards for yourself to manage your team and focusing individuals to capture opportunity data to properly report against.
Why?
• This role will be part of the sales team of Scale in the Automotive Pod, led by our VP Automotive Business. You will be a part of a high-growth sales team defining the future of AI infrastructure for customers.
• It should be noted that is an opportunity to have impact not just on revenue, but cross functionally within Scale. As we are a new company and building these functions for the first time, it is an opportunity to leave your legacy on an already high growth company.
Where?
• This position is to be remote in the E.U. with a preference on Germany. No matter where you are based, you will experience a company that believes in small teams for maximum impact; seeks well-rounded talent to ensure a full perspective on our customers’ experience, understands that this is a marathon, not a sprint; that continuously and purposefully builds an inclusive culture that empowers everyone to do their best work and be the best version of themselves. Languages: English = must, German = must, other languages advantageous.
Sales Commission:
• Additionally, this role is eligible to earn commissions.
The base salary range for this full-time position in our hub locations of San Francisco, New York, Seattle and DC is $140,000.00 - $175,000.00. Compensation packages at Scale include base salary and benefits. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position, determined by work location and additional factors, including job-related skills, experience, interview performance, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process. You’ll also receive benefits including, but not limited to: Comprehensive health, dental and vision coverage, retirement benefits, a learning and development stipend, and generous PTO. Additionally, this role may be eligible for additional benefits such as a commuter stipend Show more details...
via Glassdoor
posted_at: 3 days agoschedule_type: Full-time
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and... planet. That's why we are always looking for curious minds
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and... planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Job Title: Heads of Commercial, Process Solutions Services, NA & EU
Employer: BioReliance Corporation, 400 Summit Drive, Burlington, Massachusetts 01803
Job Location: BioReliance Corporation, 14290 Broschart Road, Rockville, Maryland 20850
Job Responsibilities:
The Heads of Commercial, Process Solutions Services, NA & EU will be responsible for building and implementing business strategies for a commercial organization in both North America and Europe. Specific job duties include the following:
• Build, coach, and develop successful teams and managers globally within GSA, Regional and EB focused segments;
• Drive and create new ways to collaborate with our client base to support and protect our revenue goals, working with a focus on business development and negotiation skills including closing of significant deals;
• Collaborate with key stakeholders to inspire internal and external patterns to "buy" in and create commitment and trust at different levels of the organization, enabling the business to meet critical objectives;
• Work with business partners and PSSLT to provide global visibility on molecules, CDMOs, competitor activity, and opportunities and business risk along with mitigation strategy;
• Operate as an escalation path for global/strategic topics;
• Collaborate with regions to successfully implement Go-To-Market Transformation in order to support revenue goals and aspirations;
• Build and drive high level detail for business plans, allowing for smoother decision making for business expansion;
• Monitor and drive both finances and financial analysis for specified targets and strategy on a quarterly and annual basis with a rolling 9 months ahead;
• Analyze, prioritize, and validate complex and dynamic information from a diverse range of external and internal sources and develop ideas and recommendations for the business; and
• Serve on the PSS Leadership team to drive and facilitate business decisions and strategy for our organization.
Telecommuting is an option.
Position requires international travel once per quarter for no more than one week per trip. In addition, 50% domestic travel required.
Job Requirements:
Employer requires a Bachelor's degree in Immunology, Microbiology, or closely related field and at least six (6) years of progressively more responsible work experience with sales management in a pharmaceutical/biopharmaceutical R&D, pharmacodynamics, or manufacturing environment. In addition, the employer requires the following:
• Demonstrated knowledge of business operations of contract testing organizations gained through at least five (5) years of work experience.
• Demonstrated ability building and implementing business strategies for a commercial organization gained through at least six (6) years of work experience.
• Demonstrated ability building and developing teams, including hiring team members, setting strategy, and meeting sales quotas in an organization that spans more than one time zone gained through at least five (5) years of work experience in a direct management role.
• Demonstrated ability managing accounts in the pharmaceutical industry with sales of more than $10 Million USD and spanning more than one continent gained through at least five (5) years of work experience.
• Demonstrated ability working with and supporting emerging biotechnology customers gained through at least five (5) years of work experience.
• Demonstrated ability building go-to-market plans for life science and biotechnology companies gained through at least five (5) years of work experience.
All years of experience may be gained concurrently.
This position is eligible for BioReliance Corporation's Employee Referral Program, which is under EMD Millipore Corporation.
Applicants can send resumes to BioReliance Corporation, 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: Req # 260821 ) or apply online at https://www.emdgroup.com/en/company.html
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html Show more details...
Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and... planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Job Title: Heads of Commercial, Process Solutions Services, NA & EU
Employer: BioReliance Corporation, 400 Summit Drive, Burlington, Massachusetts 01803
Job Location: BioReliance Corporation, 14290 Broschart Road, Rockville, Maryland 20850
Job Responsibilities:
The Heads of Commercial, Process Solutions Services, NA & EU will be responsible for building and implementing business strategies for a commercial organization in both North America and Europe. Specific job duties include the following:
• Build, coach, and develop successful teams and managers globally within GSA, Regional and EB focused segments;
• Drive and create new ways to collaborate with our client base to support and protect our revenue goals, working with a focus on business development and negotiation skills including closing of significant deals;
• Collaborate with key stakeholders to inspire internal and external patterns to "buy" in and create commitment and trust at different levels of the organization, enabling the business to meet critical objectives;
• Work with business partners and PSSLT to provide global visibility on molecules, CDMOs, competitor activity, and opportunities and business risk along with mitigation strategy;
• Operate as an escalation path for global/strategic topics;
• Collaborate with regions to successfully implement Go-To-Market Transformation in order to support revenue goals and aspirations;
• Build and drive high level detail for business plans, allowing for smoother decision making for business expansion;
• Monitor and drive both finances and financial analysis for specified targets and strategy on a quarterly and annual basis with a rolling 9 months ahead;
• Analyze, prioritize, and validate complex and dynamic information from a diverse range of external and internal sources and develop ideas and recommendations for the business; and
• Serve on the PSS Leadership team to drive and facilitate business decisions and strategy for our organization.
Telecommuting is an option.
Position requires international travel once per quarter for no more than one week per trip. In addition, 50% domestic travel required.
Job Requirements:
Employer requires a Bachelor's degree in Immunology, Microbiology, or closely related field and at least six (6) years of progressively more responsible work experience with sales management in a pharmaceutical/biopharmaceutical R&D, pharmacodynamics, or manufacturing environment. In addition, the employer requires the following:
• Demonstrated knowledge of business operations of contract testing organizations gained through at least five (5) years of work experience.
• Demonstrated ability building and implementing business strategies for a commercial organization gained through at least six (6) years of work experience.
• Demonstrated ability building and developing teams, including hiring team members, setting strategy, and meeting sales quotas in an organization that spans more than one time zone gained through at least five (5) years of work experience in a direct management role.
• Demonstrated ability managing accounts in the pharmaceutical industry with sales of more than $10 Million USD and spanning more than one continent gained through at least five (5) years of work experience.
• Demonstrated ability working with and supporting emerging biotechnology customers gained through at least five (5) years of work experience.
• Demonstrated ability building go-to-market plans for life science and biotechnology companies gained through at least five (5) years of work experience.
All years of experience may be gained concurrently.
This position is eligible for BioReliance Corporation's Employee Referral Program, which is under EMD Millipore Corporation.
Applicants can send resumes to BioReliance Corporation, 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: Req # 260821 ) or apply online at https://www.emdgroup.com/en/company.html
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html Show more details...
via Careers - Jobs - Xogene Services LLC
posted_at: 19 days agoschedule_type: Full-timework_from_home: 1
ABOUT XOGENE
Xogene is a leader in innovative technologies and expert services to meet global clinical trial transparency requirements. Since 2010, Xogene has been offering a suite of transparency services to meet evolving regulatory needs, from helping to build a newly emerging transparency capability to augmenting an already mature process...
Combining deep transparency expertise with a modern technology stack, Xogene also provides software solutions
ABOUT XOGENE
Xogene is a leader in innovative technologies and expert services to meet global clinical trial transparency requirements. Since 2010, Xogene has been offering a suite of transparency services to meet evolving regulatory needs, from helping to build a newly emerging transparency capability to augmenting an already mature process...
Combining deep transparency expertise with a modern technology stack, Xogene also provides software solutions to automate processes and track myriad studies, regulations and statuses.
Our expertise ranges from clinical trial registration and results reporting, medical writing, document redaction and lay summary development, to SAS/XML support, data sharing, online study tracking solutions, and building/hosting websites.
Xogene is headquartered in New Jersey with offices in Vienna, Austria and Gurgaon and Pune, India. As a fast growing, dynamic company, we are looking to grow our team with self-motivated, experienced medical writers and SMEs who are highly detail-oriented and organized with great communication skills. In return for the hard work and commitment to excellence from the team, Xogene offers a dynamic and meritocratic environment with great benefits and flexibility.For more information, visit us at http://www.xogene.com.
THE ROLE
Responsible for the writing of documents containing scientific data pertaining to multiple, complex clinical research and medical affairs projects.
KEY TASKS AND RESPONSIBILITIES
• Develop/write clinical documents for submission (especially investigator brochures, protocols, clinical study reports, post-study documents such as ISS, ISE, Clinical Summaries, Clinical Overview), ensuring scientific excellence, compliance with national and international regulatory requirements and guidelines, and internal procedures (as applicable).
• Oversee development/writing of clinical documents for submission (especially protocols, CSRs) by external service providers, ensuring scientific excellence, compliance with national and international regulatory requirements and guidelines, and internal procedures (as applicable).
• Provide key messages on the interpretation of clinical study results to external service providers for the development of clinical documents such as CSRs.
• Ensure compliance of clinical documents with national and international regulatory agency regulations/guidelines and departmental standard operating procedures.
• May write/review/prepare briefing books, product labels, and responses to regulatory agencies’ inquiries regarding products to support franchises.
• Work closely with clinical teams on assigned projects to ensure adherence to timelines.
• Ensure that all compositions conducted under his/her/their responsibility are performed within time, quality and cost expectations and in a manner that is both ethically and legally acceptable to all regulatory agencies.
• Work authorization
• Advance Degree in Medicine, Pharmacology, Biology or related scientific discipline; Masters degree preferred
• 3+ year(s) clinical medical writing experience or scientific writing with a pharmaceutical or biotechnology company or a contract research organization
• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products
• Understanding of FDA/EMA/international regulations, ICH guidelines, and applicable regulatory processes related to document preparation and production (including CTDs)
• Expertise in analytical evaluation of scientific data, organizational skills, and the ability to work in a team environment
• Knowledge of plasma derived therapeutic areas (products and therapies) or related scientific areas
• Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas
• Strong computer skills with Microsoft Word, Excel, PowerPoint and Adobe (or any other PDF-related program)
• Meticulous attention to detail
• Intercultural understanding with a global perspective Show more details...
Xogene is a leader in innovative technologies and expert services to meet global clinical trial transparency requirements. Since 2010, Xogene has been offering a suite of transparency services to meet evolving regulatory needs, from helping to build a newly emerging transparency capability to augmenting an already mature process...
Combining deep transparency expertise with a modern technology stack, Xogene also provides software solutions to automate processes and track myriad studies, regulations and statuses.
Our expertise ranges from clinical trial registration and results reporting, medical writing, document redaction and lay summary development, to SAS/XML support, data sharing, online study tracking solutions, and building/hosting websites.
Xogene is headquartered in New Jersey with offices in Vienna, Austria and Gurgaon and Pune, India. As a fast growing, dynamic company, we are looking to grow our team with self-motivated, experienced medical writers and SMEs who are highly detail-oriented and organized with great communication skills. In return for the hard work and commitment to excellence from the team, Xogene offers a dynamic and meritocratic environment with great benefits and flexibility.For more information, visit us at http://www.xogene.com.
THE ROLE
Responsible for the writing of documents containing scientific data pertaining to multiple, complex clinical research and medical affairs projects.
KEY TASKS AND RESPONSIBILITIES
• Develop/write clinical documents for submission (especially investigator brochures, protocols, clinical study reports, post-study documents such as ISS, ISE, Clinical Summaries, Clinical Overview), ensuring scientific excellence, compliance with national and international regulatory requirements and guidelines, and internal procedures (as applicable).
• Oversee development/writing of clinical documents for submission (especially protocols, CSRs) by external service providers, ensuring scientific excellence, compliance with national and international regulatory requirements and guidelines, and internal procedures (as applicable).
• Provide key messages on the interpretation of clinical study results to external service providers for the development of clinical documents such as CSRs.
• Ensure compliance of clinical documents with national and international regulatory agency regulations/guidelines and departmental standard operating procedures.
• May write/review/prepare briefing books, product labels, and responses to regulatory agencies’ inquiries regarding products to support franchises.
• Work closely with clinical teams on assigned projects to ensure adherence to timelines.
• Ensure that all compositions conducted under his/her/their responsibility are performed within time, quality and cost expectations and in a manner that is both ethically and legally acceptable to all regulatory agencies.
• Work authorization
• Advance Degree in Medicine, Pharmacology, Biology or related scientific discipline; Masters degree preferred
• 3+ year(s) clinical medical writing experience or scientific writing with a pharmaceutical or biotechnology company or a contract research organization
• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products
• Understanding of FDA/EMA/international regulations, ICH guidelines, and applicable regulatory processes related to document preparation and production (including CTDs)
• Expertise in analytical evaluation of scientific data, organizational skills, and the ability to work in a team environment
• Knowledge of plasma derived therapeutic areas (products and therapies) or related scientific areas
• Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas
• Strong computer skills with Microsoft Word, Excel, PowerPoint and Adobe (or any other PDF-related program)
• Meticulous attention to detail
• Intercultural understanding with a global perspective Show more details...
via Salary.com
posted_at: 12 days agoschedule_type: Full-time
Company Description
VTekis Consulting LLC provides complete solutions for Staff Agumentation, Recruitment Process Outsourcing, Contract Hiring, Direct Hire and Outsourced Solutions. Our goal is to deliver quality professional services to our clients not just to find someone to do a job, we match the right professional for your staffing needs and earning confidence through the proper assignment... of people. This alignment of people and companies
Company Description
VTekis Consulting LLC provides complete solutions for Staff Agumentation, Recruitment Process Outsourcing, Contract Hiring, Direct Hire and Outsourced Solutions. Our goal is to deliver quality professional services to our clients not just to find someone to do a job, we match the right professional for your staffing needs and earning confidence through the proper assignment... of people. This alignment of people and companies allows us to create opportunity. Most importantly, We don’t consider the process complete until we find the perfect fit.
Job Description
Responsibilities:
· Responsible for implementing and maintaining the effectiveness of the quality system.
· Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
· Provide regulatory input to product lifecycle planning
· Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
· Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes
· Assist in regulatory due diligence for potential and new acquisitions
· Utilize technical regulatory skills to propose strategies on complex issues
· Determine submission and approval requirements
· Monitor trade association positions for impact on company products
· Anticipate and identify regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
· Recruit; develop and mentor regulatory professionals
· Assess the acceptability of quality; pre-clinical and clinical documentation for submission filing
· Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
· Compile; prepare; review and submit regulatory submission to authorities
· Monitor impact of changing regulations on submission strategies and update internal stakeholders
· Monitor applications under regulatory review
· Oversee processes involved with maintaining annual licenses; registrations; listings and patent information
· Ensure compliance with product post marketing approval requirements
· Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events
· Actively contribute to the development and functioning of the crisis/issue management program
· Provide regulatory input for product recalls and recall communications
· Report adverse events to regulatory agencies and internal stakeholders
· Review and approve advertising and promotional items to ensure regulatory compliance.
Thanks and Regards,
Mohammed Ilyas
PH - 229-264-4029.
Additional Information
All your information will be kept confidential according to EEO guidelines. Show more details...
VTekis Consulting LLC provides complete solutions for Staff Agumentation, Recruitment Process Outsourcing, Contract Hiring, Direct Hire and Outsourced Solutions. Our goal is to deliver quality professional services to our clients not just to find someone to do a job, we match the right professional for your staffing needs and earning confidence through the proper assignment... of people. This alignment of people and companies allows us to create opportunity. Most importantly, We don’t consider the process complete until we find the perfect fit.
Job Description
Responsibilities:
· Responsible for implementing and maintaining the effectiveness of the quality system.
· Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
· Provide regulatory input to product lifecycle planning
· Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
· Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes
· Assist in regulatory due diligence for potential and new acquisitions
· Utilize technical regulatory skills to propose strategies on complex issues
· Determine submission and approval requirements
· Monitor trade association positions for impact on company products
· Anticipate and identify regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
· Recruit; develop and mentor regulatory professionals
· Assess the acceptability of quality; pre-clinical and clinical documentation for submission filing
· Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
· Compile; prepare; review and submit regulatory submission to authorities
· Monitor impact of changing regulations on submission strategies and update internal stakeholders
· Monitor applications under regulatory review
· Oversee processes involved with maintaining annual licenses; registrations; listings and patent information
· Ensure compliance with product post marketing approval requirements
· Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events
· Actively contribute to the development and functioning of the crisis/issue management program
· Provide regulatory input for product recalls and recall communications
· Report adverse events to regulatory agencies and internal stakeholders
· Review and approve advertising and promotional items to ensure regulatory compliance.
Thanks and Regards,
Mohammed Ilyas
PH - 229-264-4029.
Additional Information
All your information will be kept confidential according to EEO guidelines. Show more details...
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