Total 43 job vacancies by Vertex Pharmaceuticals Inc (US)

Job Description

The Vertex Co-op Program offers students the opportunity to learn about the pharmaceutical industry from a hands-on perspective. You will be working closely with and learning from some of the brightest people in the industry. When you join our co-op program you should not be surprised to see that our environment is one that is innovative and team oriented, where collaboration is not just a word, and "we are relentless" is in everything we do. Students can expect to be challenged by their project plan, connect with other co-ops, and feel valued by the Vertex community. Not only will co-ops learn about their day-to-day tasks through their specific work assignments, but they will interact and have exposure to our organizational leaders and their teams.

Job Summary:

Our team focuses on bringing together the best of biology, translational engineering, modeling and simulation, data science, and prototyping capabilities to develop cutting-edge transformative cell and gene delivery platforms. In this position the candidate will play a key role within a dynamic R&D team working at the interface of cell delivery and immunology research as they relate to macroencapsulation, immunoprotection, and other methods for alleviating or engineering the host response.

Key Responsibilities:

The candidate will make contributions in developing in vitro models of host response, particularly a high throughput platform in which to test new strategies for next-generation delivery technologies. Further, the candidate will support development of new delivery strategies to circumvent the immune system and improve cell survival. Day-to-day job duties include routine primary cell culture under aseptic conditions, perform in vitro assays for monitoring cell stress, viability, and performance including antibody immunostaining, ELISA, luminescent staining and cryosectioning.

Qualifications:

Company Information

Job Description

Vertex is seeking experienced and talented commercial leaders to join our US Pain Business Unit to support our journey to bring forth new options for the treatment of pain. The Territory Account Manager will be responsible for establishing and maintaining relationships with key institutional decision makers and affiliated Health Care Professionals (HCPs) to generate advocacy and drive sales growth for the US Pain Business Unit, which is preparing for potential commercialization of an investigational novel selective inhibitor of NaV1.8 in acute pain. We are looking for candidates with a strong track record of delivering exceptional results with patient focus, developing deep & strategic account relationships, and executing strategic account plans. Consistently demonstrating behaviors that embody Vertex’s values and earn the trust of stakeholders, developing deep expertise in the science and data for products, and staying focused, resilient, and adaptable. This role will report into a Regional Field Director and will be responsible for leading engagement with 15-20 institutions (hospitals & ambulatory surgery centers) as well as select priority community physician offices.

There are several Pain Territory Account Manager openings in the broader state - the successful candidate must live within the identified territory near an airport and be willing to travel routinely based on business needs.

For more information about Vertex’s pain program, visit https://www.vrtx.com/research-development/pipeline/pain/.  To learn more about working at Vertex and our commitment to a vibrant and inclusive culture, visit https://www.vrtx.com/working-here/inclusion-diversity-equity/.
 

Key Responsibilities:

• Establishes meaningful and professional relationships within key accounts across multiple layers of the hospital system (key hospital medical and administrative staff, pharmacies, formulary decision makers and KTLs)

• Develops and maintains expertise on the product’s clinical attributes and patient unmet need and educates healthcare professionals on product use in appropriate patients  

• Navigates the formulary process and delivers key product value content to ensure timely inclusion on formularies, pathways, and/or protocols within targeted institutions and systems 

• Develop a deep understanding of the institutional customer, account & market dynamics, stakeholder mapping, key decision maker relationship management, patient protocols, referral network navigation, access, and account department drivers & barriers.

• Implements and maintains strategic account plans that identify and harness business opportunities and patient-focused solutions for significant growth across the customer landscape

• Drives sales performance and ensures forecasts and assigned budgets meet or exceed territory expectations

• Collaborates compliantly with other field team members (e.g., field medical, HEOR, IDN and Payer Account teams) and headquarter colleagues to create aligned business plans, focus on strategic drivers, share best practices, and inform initiatives

• Role models ethics and integrity in the work that you do to support our culture of compliance and earn trust with external stakeholders, particularly in the context of this market and its history
   

Required Education and Experience

• Bachelor’s degree

• 7+ experience in biotech sales; hospital/institution product launch experience is highly desired

• 3+ years of Account Management experience and ability to leverage existing institutional relationships

• Proven ability to navigate hospital institutions and systems and engage formulary management and pharmaceutical product review, to gain product access and impact key decision makers and affiliated community prescribers

• Experience with pulling through the implementation of inpatient formularies , protocols, pathways, and order sets

• Highly competent in a multitude of IT capabilities to support the business needs including CRM

• Experience in launching new products preferred

Customer-Facing Role Requirements:

• Employee will be required to establish certain customer credentials and requirements, which include, but may not be limited to, successful completion of trainings, background screens, drug testing and vaccinations.

• Must live and work within the territory. Depending on the territory’s geography and work requirements may also be required to live within a reasonable distance to a major airport

• Valid driver’s license and in good standing

• Travel by car or airplane up to 80% of the time and work after hours as required by business needs

• 10-30% of overnight travel may be required depending on territory

#LI-AS1

#LI-Remote

Pay range is $133,000 - $200,000 annually

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role may also be eligible for commission, fleet or car allowance and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

Company Information

Job Description

General Summary:

The Supervisor, Manufacturing Operations leads shift work in the cell therapy clinical manufacturing facility, assigning work according to detailed schedules and plans. Responsible for daily cGMP operations in the Vertex Drug Product Facility, including the set-up, assembly, operation, disassembly, and cleaning of process equipment, and overseeing the daily work of shift personnel.

Responsible for daily operations and staff allocations for first shift personnel.

Key Duties and Responsibilities:

• Interface with relevant cross functional groups necessary for the operation and maintenance of the facility and manufacturing of drug product.

• Execute and witness batch record instructions during cGMP operations.

• Maintain facility in an audit ready state.

• Supervise manufacturing personnel

• Monitor GMP compliance in all cGMP activities with co-workers and anyone working within the Drug Product facility.

• Maintain compliance with all on-going training requirements.

• Follow SOPs, policies and all other relevant work instructions to ensure the successful and compliance operation of the drug product facility.

Knowledge and Skills:

• A solid understanding of the cGMP framework in the context of both development and commercial pharmaceutical drug product manufacturing environment.

• Ability to follow verbal and written instructions in English.

• Visual Acuity.

• Ability to distinguish between the colors red, yellow, blue and green.

• Ability to lift up to 50lbs.

• Strong organizational skills.

• Strong communication skills, as well as excellent documentation skills.

• Basic computer skills and demonstrated ability to learn new systems and understand new technologies.

• Occasional availability to work on other shifts may be necessary for onboarding and training.

Experience:

• Typically requires 3 years of relevant work experience or the equivalent combination of education and experience

• Supervisory experience

• Experience with manufacturing systems utilizing computerized control systems and HMIs

• Experience with continuous manufacturing and with manufacturing processes relevant to cell and gene therapy

Company Information

Job Description

Vertex is seeking experienced and talented commercial leaders to join our US Pain Business Unit to support our journey to bring forth new options for the treatment of pain. The Territory Account Manager will be responsible for establishing and maintaining relationships with key institutional decision makers and affiliated Health Care Professionals (HCPs) to generate advocacy and drive sales growth for the US Pain Business Unit, which is preparing for potential commercialization of an investigational novel selective inhibitor of NaV1.8 in acute pain. We are looking for candidates with a strong track record of delivering exceptional results with patient focus, developing deep & strategic account relationships, and executing strategic account plans. Consistently demonstrating behaviors that embody Vertex’s values and earn the trust of stakeholders, developing deep expertise in the science and data for products, and staying focused, resilient, and adaptable. This role will report into a Regional Field Director and will be responsible for leading engagement with 15-20 institutions (hospitals & ambulatory surgery centers) as well as select priority community physician offices.

There are several Pain Territory Account Manager openings in the broader state - the successful candidate must live within the identified territory near an airport and be willing to travel routinely based on business needs.

For more information about Vertex’s pain program, visit https://www.vrtx.com/research-development/pipeline/pain/.  To learn more about working at Vertex and our commitment to a vibrant and inclusive culture, visit https://www.vrtx.com/working-here/inclusion-diversity-equity/.
 

Key Responsibilities:

• Establishes meaningful and professional relationships within key accounts across multiple layers of the hospital system (key hospital medical and administrative staff, pharmacies, formulary decision makers and KTLs)

• Develops and maintains expertise on the product’s clinical attributes and patient unmet need and educates healthcare professionals on product use in appropriate patients  

• Navigates the formulary process and delivers key product value content to ensure timely inclusion on formularies, pathways, and/or protocols within targeted institutions and systems 

• Develop a deep understanding of the institutional customer, account & market dynamics, stakeholder mapping, key decision maker relationship management, patient protocols, referral network navigation, access, and account department drivers & barriers.

• Implements and maintains strategic account plans that identify and harness business opportunities and patient-focused solutions for significant growth across the customer landscape

• Drives sales performance and ensures forecasts and assigned budgets meet or exceed territory expectations

• Collaborates compliantly with other field team members (e.g., field medical, HEOR, IDN and Payer Account teams) and headquarter colleagues to create aligned business plans, focus on strategic drivers, share best practices, and inform initiatives

• Role models ethics and integrity in the work that you do to support our culture of compliance and earn trust with external stakeholders, particularly in the context of this market and its history
   

Required Education and Experience

• Bachelor’s degree

• 7+ experience in biotech sales; hospital/institution product launch experience is highly desired

• 3+ years of Account Management experience and ability to leverage existing institutional relationships

• Proven ability to navigate hospital institutions and systems and engage formulary management and pharmaceutical product review, to gain product access and impact key decision makers and affiliated community prescribers

• Experience with pulling through the implementation of inpatient formularies , protocols, pathways, and order sets

• Highly competent in a multitude of IT capabilities to support the business needs including CRM

• Experience in launching new products preferred

Customer-Facing Role Requirements:

• Employee will be required to establish certain customer credentials and requirements, which include, but may not be limited to, successful completion of trainings, background screens, drug testing and vaccinations.

• Must live and work within the territory. Depending on the territory’s geography and work requirements may also be required to live within a reasonable distance to a major airport

• Valid driver’s license and in good standing

• Travel by car or airplane up to 80% of the time and work after hours as required by business needs

• 10-30% of overnight travel may be required depending on territory

#LI-AS1

#LI-Remote

Pay range is $133,000 - $200,000 annually

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role may also be eligible for commission, fleet or car allowance and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

Company Information

Job Description

Vertex is seeking experienced and talented commercial leaders to join our US Pain Business Unit to support our journey to bring forth new options for the treatment of pain. The Territory Account Manager will be responsible for establishing and maintaining relationships with key institutional decision makers and affiliated Health Care Professionals (HCPs) to generate advocacy and drive sales growth for the US Pain Business Unit, which is preparing for potential commercialization of an investigational novel selective inhibitor of NaV1.8 in acute pain. We are looking for candidates with a strong track record of delivering exceptional results with patient focus, developing deep & strategic account relationships, and executing strategic account plans. Consistently demonstrating behaviors that embody Vertex’s values and earn the trust of stakeholders, developing deep expertise in the science and data for products, and staying focused, resilient, and adaptable. This role will report into a Regional Field Director and will be responsible for leading engagement with 15-20 institutions (hospitals & ambulatory surgery centers) as well as select priority community physician offices.

There are several Pain Territory Account Manager openings in the broader state - the successful candidate must live within the identified territory near an airport and be willing to travel routinely based on business needs.

For more information about Vertex’s pain program, visit https://www.vrtx.com/research-development/pipeline/pain/.  To learn more about working at Vertex and our commitment to a vibrant and inclusive culture, visit https://www.vrtx.com/working-here/inclusion-diversity-equity/.
 

Key Responsibilities:

• Establishes meaningful and professional relationships within key accounts across multiple layers of the hospital system (key hospital medical and administrative staff, pharmacies, formulary decision makers and KTLs)

• Develops and maintains expertise on the product’s clinical attributes and patient unmet need and educates healthcare professionals on product use in appropriate patients  

• Navigates the formulary process and delivers key product value content to ensure timely inclusion on formularies, pathways, and/or protocols within targeted institutions and systems 

• Develop a deep understanding of the institutional customer, account & market dynamics, stakeholder mapping, key decision maker relationship management, patient protocols, referral network navigation, access, and account department drivers & barriers.

• Implements and maintains strategic account plans that identify and harness business opportunities and patient-focused solutions for significant growth across the customer landscape

• Drives sales performance and ensures forecasts and assigned budgets meet or exceed territory expectations

• Collaborates compliantly with other field team members (e.g., field medical, HEOR, IDN and Payer Account teams) and headquarter colleagues to create aligned business plans, focus on strategic drivers, share best practices, and inform initiatives

• Role models ethics and integrity in the work that you do to support our culture of compliance and earn trust with external stakeholders, particularly in the context of this market and its history
   

Required Education and Experience

• Bachelor’s degree

• 7+ experience in biotech sales; hospital/institution product launch experience is highly desired

• 3+ years of Account Management experience and ability to leverage existing institutional relationships

• Proven ability to navigate hospital institutions and systems and engage formulary management and pharmaceutical product review, to gain product access and impact key decision makers and affiliated community prescribers

• Experience with pulling through the implementation of inpatient formularies , protocols, pathways, and order sets

• Highly competent in a multitude of IT capabilities to support the business needs including CRM

• Experience in launching new products preferred

Customer-Facing Role Requirements:

• Employee will be required to establish certain customer credentials and requirements, which include, but may not be limited to, successful completion of trainings, background screens, drug testing and vaccinations.

• Must live and work within the territory. Depending on the territory’s geography and work requirements may also be required to live within a reasonable distance to a major airport

• Valid driver’s license and in good standing

• Travel by car or airplane up to 80% of the time and work after hours as required by business needs

• 10-30% of overnight travel may be required depending on territory

#LI-KM3

#LI-Remote

Pay range is $133,000 - $200,000 annually

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role may also be eligible for commission, fleet or car allowance and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

Company Information

Job Description

The Vertex Co-op Program offers students the opportunity to learn about the pharmaceutical industry from a hands-on perspective. You will be working closely with and learning from some of the brightest people in the industry. When you join our co-op program you should not be surprised to see that our environment is one that is innovative and team oriented, where collaboration is not just a word, and "we are relentless" is in everything we do. Students can expect to be challenged by their project plan, connect with other co-ops, and feel valued by the Vertex community. Not only will co-ops learn about their day-to-day tasks through their specific work assignments, but they will interact and have exposure to our organizational leaders and their teams.

Job Summary:

Engineering Sciences is seeking a co-op to join the Biomechanics group within VCGT. This role will support R&D initiatives with a focus on mechanical testing and fixture design. The successful candidate will have strong technical skills and a demonstrable understanding of complex mechanical engineering concepts. Additionally, the candidate will have strong hands-on expertise in mechanical design and rapid prototyping. This position is based in Providence, RI, and will report to the Translational Engineering Senior Scientist.

Key Responsibilities:

• Execute quasi-static mechanical tests (tensile testing, peel-testing, flexural testing) to quantify mechanical properties of biomaterials under relevant loading conditions.
• Run dynamic mechanical tests (fatigue) to evaluate the fatigue performance of next-generation device concepts.
• Utilize rapid prototyping capabilities to build and test custom mechanical fixtures.
• Execute daily maintenance on 3D printers and Mechanical Test Systems.
• Comply with all Company Policies including Health, Safety, and Environmental Regulations, Personal Protective Equipment Requirements, and Standard Operating Procedures.

Qualifications:

• Enrolled in an undergraduate or graduate program in Mechanical Engineering, Biomedical Engineering, Physics, or similar background
• Proficiency in mechanical engineering concepts, mechanical testing, and statistical analysis.
• Proficiency in CAD(i.e. Solidworks, AutoCAD, etc) and DFM
•  Experience with 3D printing a bonus
• Strong verbal and written communications skills with ability to effectively communicate with multiple teams.
• Ability to work in a fast-paced environment and multitask, comfortable with changing Work Environments and priorities.
• Proven ability to monitor own Work Product, ensuring quality, accuracy, and thoroughness; able to self-motivate and work independently or as part of a larger team.

• Legally authorized to work in the United States
• Enrolled in an undergraduate or graduate program
• Candidate must be enrolled in an advanced degree program if graduating before December 2024
• Candidate must be available to work full-time, 40 hours per week from July 10, 2024 – December 20, 2024

Program Dates: July - December 2024, Full Time

This job posting is for a temporary role with a third-party agency partner that provides services to Vertex.  The individual selected for this role will be offered the role as an employee of that third-party agency; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency upon offer.

Company Information

Job Description

Executive Director/Senior Director, Global Commercial Strategy Pain

Boston, MA (3 days onsite, 2 days remote weekly)

Vertex Pharmaceuticals is seeking a Executive Director or Senior Director of Global Commercial Strategy reporting to the VP Global Commercial Lead for Pain to join our dynamic team in Boston, MA. The candidate will take responsibility for global marketing decisions and tactics that lead Life Cycle Management, portfolio and commercial strategy development whilst supporting the team on successful launches on the pain programs. This will involve shaping global commercial strategy in pain portfolio and developing both strategies and resources to be used by the Regions in their interactions with stakeholders for years to come.  The successful candidate serves as a voice of the community to ensure patients remain at the center of decisions.

The candidate will play a key role in leading the development of the Pain Portfolio strategy.  The role will have a strong focus on Vertex’s outlook in pain across assets, indications and geographies.   This role will integrate launch preparation for ‘Next in class’ molecules with New Product planning.  They will lead development of key deliverables of Pain portfolio strategy including the 3–5 year commercialization strategy. A member of the Early Pipeline team (PT), the coordinating body for the portfolio pipeline in pain, will work closely with cross-functional matrix colleagues to ensure attainment of corporate objectives. The candidate will be the ‘right hand’ to the commercial lead for Pain ensuring aligned commercialization position on pipeline for the Disease Strategy Team and senior leadership. The successful candidate is highly strategic, thrives in an environment of uncertainty and rapid change, demonstrates strong leadership, works effectively within cross-functional teams, and has a problem-solving mindset backed by strong analytical skills. The candidate must share our passion for science-based brands that can dramatically improve patients' lives.

As a senior member on the pain team, the successful candidate must be able to role model Vertex’s ethics & culture and be committed to developing the next generation of leaders.

Key Responsibilities:

• Lead and ensure successful development and implementation of the commercialization (midterm) and portfolio (long term) strategies including brand development, competitive strategy, go-to-market/launch, and lifecycle decisions for future launches. Execute in close partnership with the Regions, Market Access, Regulatory and Commercial Manufacturing.

• Deliver foundational insights about the evolving landscape of pain today and in future, with focus on patients and providers, managing external consultants together with Marketing Science and Market Access

• Execute key global initiatives to prepare the market, enable strong uptake and sustain commercial success.

• Play a key role on the Early PT, integrating commercial position into pain pipeline strategy. There will also be potential to lead ‘Next-in-Class’ PT.

• Support the Global Commercial Team by providing clear direction for the pain portfolio as the primary forum for commercial collaboration and alignment.

• Represent the Commercial team in projects led by others e.g. label development, initiatives, etc.

• Partner with RWE and HEOR to continually evolve our understanding of addressable patient populations, providing input to relevant cross-functional teams (ClinDev, GPMA, HEOR).

• As a senior member of Global Commercial Strategy Pain team they will provide a mentoring/role model to the team.

Qualifications

• Bachelor’s degree required, ideally in life sciences

• Typically requires 12+ years of work experience or the equivalent combination of education and experience  

• In country launch experience, particularly in small molecule/pain, US market experience required and multiple-market experience highly desired.

• Experience in global marketing, new product planning as well as commercial operations or analytics desirable, especially involving product launches.

• Demonstrated ability to work independently and manage initiatives that require collaboration across multiple functional areas.

• An entrepreneurial spirit and an ability to develop creative solutions to complex problems.

• Excellent communication skills

• A solid compliance mindset, demonstrated integrity on the job, embrace of the Vertex Values. 

• Vertex welcomes applicants from diverse backgrounds and promotes an inclusive work-place environment.

#LI-KM3

Company Information

Job Description

Vertex is seeking experienced and talented commercial leaders to join our US Pain Business Unit to support our journey to bring forth new options for the treatment of pain. The Territory Account Manager will be responsible for establishing and maintaining relationships with key institutional decision makers and affiliated Health Care Professionals (HCPs) to generate advocacy and drive sales growth for the US Pain Business Unit, which is preparing for potential commercialization of an investigational novel selective inhibitor of NaV1.8 in acute pain. We are looking for candidates with a strong track record of delivering exceptional results with patient focus, developing deep & strategic account relationships, and executing strategic account plans. Consistently demonstrating behaviors that embody Vertex’s values and earn the trust of stakeholders, developing deep expertise in the science and data for products, and staying focused, resilient, and adaptable. This role will report into a Regional Field Director and will be responsible for leading engagement with 15-20 institutions (hospitals & ambulatory surgery centers) as well as select priority community physician offices.

There are several Pain Territory Account Manager openings in the broader state - the successful candidate must live within the identified territory near an airport and be willing to travel routinely based on business needs.

For more information about Vertex’s pain program, visit https://www.vrtx.com/research-development/pipeline/pain/.  To learn more about working at Vertex and our commitment to a vibrant and inclusive culture, visit https://www.vrtx.com/working-here/inclusion-diversity-equity/.
 

Key Responsibilities:

• Establishes meaningful and professional relationships within key accounts across multiple layers of the hospital system (key hospital medical and administrative staff, pharmacies, formulary decision makers and KTLs)

• Develops and maintains expertise on the product’s clinical attributes and patient unmet need and educates healthcare professionals on product use in appropriate patients  

• Navigates the formulary process and delivers key product value content to ensure timely inclusion on formularies, pathways, and/or protocols within targeted institutions and systems 

• Develop a deep understanding of the institutional customer, account & market dynamics, stakeholder mapping, key decision maker relationship management, patient protocols, referral network navigation, access, and account department drivers & barriers.

• Implements and maintains strategic account plans that identify and harness business opportunities and patient-focused solutions for significant growth across the customer landscape

• Drives sales performance and ensures forecasts and assigned budgets meet or exceed territory expectations

• Collaborates compliantly with other field team members (e.g., field medical, HEOR, IDN and Payer Account teams) and headquarter colleagues to create aligned business plans, focus on strategic drivers, share best practices, and inform initiatives

• Role models ethics and integrity in the work that you do to support our culture of compliance and earn trust with external stakeholders, particularly in the context of this market and its history
   

Required Education and Experience

• Bachelor’s degree

• 7+ experience in biotech sales; hospital/institution product launch experience is highly desired

• 3+ years of Account Management experience and ability to leverage existing institutional relationships

• Proven ability to navigate hospital institutions and systems and engage formulary management and pharmaceutical product review, to gain product access and impact key decision makers and affiliated community prescribers

• Experience with pulling through the implementation of inpatient formularies , protocols, pathways, and order sets

• Highly competent in a multitude of IT capabilities to support the business needs including CRM

• Experience in launching new products preferred

Customer-Facing Role Requirements:

• Employee will be required to establish certain customer credentials and requirements, which include, but may not be limited to, successful completion of trainings, background screens, drug testing and vaccinations.

• Must live and work within the territory. Depending on the territory’s geography and work requirements may also be required to live within a reasonable distance to a major airport

• Valid driver’s license and in good standing

• Travel by car or airplane up to 80% of the time and work after hours as required by business needs

• 10-30% of overnight travel may be required depending on territory

#LI-

#LI-Remote

Pay range is $133,000 - $200,000 annually

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role may also be eligible for commission, fleet or car allowance and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

Company Information

Job Description

General position summary:

The Associate Director, Quality role will work with the GDP Operational QA Management team to ensure that medicines are distributed in the US in compliance with GDP and GMP requirements.  The position will manage the day to day Quality oversight of the Third Party Logistics provider and provide support for key stakeholders within Vertex. 

This Position Reports to: Director, GDP Operational Quality, International QA

Key Accountabilities:

• Serve as the primary contact and have oversight of Distribution and Logistics partners within the US, including:
  • Preparation and maintenance of Quality Agreements
  • Review of deviations, CAPA and changes
  • Maintaining KPIs
  • Analyze, resolve, or assist in solving compliance and customer issues.
  • Escalation of issues
• Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS
• Accountable for New Product Launch activities within the US providing distribution requirements and expectations.
• Working collaboratively with key internal stakeholders

Key Responsibilities:

• Maintain QMS within the Vertex Inc.
• Ensure distribution licences (where required) accurately reflect the current organisation, vary licence where necessary
• Support recalls, mock recalls and any other on-market activity.
• Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.
• Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches.
• Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licences (or equivalent) application, audits, and Quality Agreements.
• Planning/ Preparation/supporting/hosting for Regulatory inspections
• Providing front and backroom inspection support
• Post inspection follow-up with responses and CAPAs (Continuous improvements)
• Manage/Approve/Assess event investigations “deviations” (including Fast Track deviations)
• Manage CAPAs and Effectiveness Checks
• Perform other duties as per GDP guidelines and Vertex policies and procedures
  • Work with Vertex Product Complaints team to ensure that customer complaints are dealt with effectively.
  • Ensure that customers and suppliers are approved
  • Approving any subcontracting activities that may impact GDP.
  • Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
  • Deciding on the final disposition of returned, rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock.
  • Ensure that any additional requirements imposed on certain products by national law are adhered to.
• Create/review and approve Standard operating Procedures and other Quality Documents

Minimum qualifications:

Master’s degree and 4-5 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 9+ years of relevant work experience, or relevant comparable background.

Preferred Qualifications:

• Bachelor's in a scientific or allied health field and relevant GDP & GMP work experience, or relevant comparable background.
• 5+ years’ experience serving in a Quality role.
• Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.
• Influencing skills in areas with no direct reporting authority.
• Strong interpersonal and communication skills.
• Auditing skills, appropriate qualifications in auditing an advantage.
• Fluency in English is required
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as: 

Hybrid: work remotely up to two days per week; or select

On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid

Company Information

Job Description

The Vertex Co-op Program offers students the opportunity to learn about the pharmaceutical industry from a hands-on perspective. You will be working closely with and learning from some of the brightest people in the industry. When you join our co-op program you should not be surprised to see that our environment is one that is innovative and team oriented, where collaboration is not just a word, and "we are relentless" is in everything we do. Students can expect to be challenged by their project plan, connect with other co-ops, and feel valued by the Vertex community. Not only will co-ops learn about their day-to-day tasks through their specific work assignments, but they will interact and have exposure to our organizational leaders and their teams.

Job Summary:

Our department is a highly collaborative collection of groups consisting of biology, engineering, modeling and simulation, and prototyping, centered around developing cutting-edge transformative cell and gene delivery platforms. In this position the intern will support routine analytical testing and material characterization, in addition to assisting with fixture design, prototyping, data scraping and data organization.

Key Responsibilities:

The candidate will perform routine analytical testing utilizing equipment such as: Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Scanning Electron Microscope (SEM), Capillary Flow Porometry (CFP), and mechanical testing on Instron Universal Testing Systems. In addition to routine testing, the candidate will assist with: fixture design and prototyping using SolidWorks and 3D printers (SLA and FDM), and data analysis using statistical programs such as JMP, Minitab, and GraphPad.

Qualifications:

• The candidate must be enrolled in an accredited college/institution and be in good academic standing pursuing a Bachelors or Masters Degree in Biomedical Engineering, Chemical Engineering, Mechanical Engineering or similar field.
• Only students in their Senior year or above will be considered.
• The candidate should be a driven individual with an interest in medical device development.
• Proven ability to monitor own Work Product, ensuring quality, accuracy, and thoroughness; able to self-motivate and work independently or as part of a larger team.
• Ability to work in a fast-paced environment and multitask, comfortable with changing Work Environments and priorities.
• Strong verbal and written communications skills with ability to effectively communicate with multiple teams.
• Experience in a lab environment.
• Experience with SolidWorks and 3D printing.
• Legally authorized to work in the United States
• Candidate must be enrolled in an advanced degree program if graduating before December 2024
• Candidate must be available to work full-time, 40 hours per week from July 10, 2024 – December 20, 2024

Program Dates: July - December 2024, Full Time

This job posting is for a temporary role with a third-party agency partner that provides services to Vertex.  The individual selected for this role will be offered the role as an employee of that third-party agency; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency upon offer.

Company Information

Job Description

General Summary:

The Quality Systems Director provides technical and strategic leadership for quality systems, quality governance, and quality culture for the cell and gene therapy business unit.  This position focuses not just on the “what” but the “how”, ensuring phase appropriate quality compliance

***This is a hybrid role working 3 days on-site and up to 2 days remotely.**

Key Duties and Responsibilities:

• Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies
• Leads and drives improvements to quality governance forums identifying risks and driving overall compliance and quality maturity
• Provides oversight, support, and drives continuous improvement to quality systems such as change control.  Focuses not just on the process, but the content and compliance of the executed records and helps drive maturity throughout the overall organization.   
• Participates in cross-functional projects in Quality expert and leader role
• Collaborate with internally and external business partners across the organization
• Provides strategies and tactics to address compliance gaps or determines enhancements to improve the overall quality culture of the programs
• As a people manager within the organization, provides leadership, development and coaching to staff, in addition may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Expert knowledge of global GMP requirements governing CGT products
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Strong technical knowledge including but not limited to: QMS, risk management, change control and governance.
• Solid quality culture knowledge and understanding of how to influence and improve overall compliance
• Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
• Experience across multiple GxP areas
• Proven ability to identify and analyze performance indicators.

Education and Experience:

• Bachelor's degree in a scientific discipline, operations research, operations management, or a related field
• Typically requires 10 years of relevant experience and 2 years of supervisor/management experience, or the equivalent combination of education and experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

In this Hybrid-Eligible role, you can choose to be designated as: 

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Company Information

Job Description

Vertex Pharmaceuticals is seeking a Health Economics & Outcomes Research (HEOR) Associate Director - pain to join the North America HEOR team.  This role will support and develop key HEOR tactics to ensure successful commercialization of novel NaV 1.8 inhibitors for acute and chronic pain in the United States (US) and Canada. This person will work in a highly cross-functional matrix team environment to ensure a seamless alignment of HEOR projects within the broader market access, policy, and medical strategy.  This person is expected to exhibit a strong sense of urgency to achieve corporate objectives while maintaining the highest ethical, regulatory and scientific standards.  This position reports to the Director, Pain launch lead, North America HEOR.

Key Responsibilities

• Own development of tactics for innovative HEOR solutions and deliverables that directly support optimal patient access to in the US and Canada throughout the product’s lifecycle  
• Drive the development of external customer-facing value demonstration tools in accordance with regulatory standards, in close collaboration with formal review bodies (e.g., Commercial Review Committee; Medical Review Committee) while supporting appropriate field teams (e.g., field HEOR, payer team)
• Work closely with global HEOR team to provide the US and Canadian perspective to evidence generation activities and to ensure timely and effective translation of HEOR studies for field use
• Directly engage with external customers (e.g., payer accounts) to deliver HEOR presentations when appropriate/requested
• Own execution of local HEOR studies in partnership with customers (e.g., payers, integrated health systems)

Qualifications

• Advanced degree (e.g. PhD, MD, MPH, or PharmD) in a scientific discipline.  
• Typically requires 8+ years of experience, with substantial background in HEOR, or the equivalent combination of education and experience. US launch experience in pain and/or other primary market experience is preferred.
• Robust understanding of the 2018 FDA Payor Guidance to payer communication in the US is strongly preferred.
• Understanding of the HTA process and methodology; hands-on experience with HTA dossier submission and review is preferred.
• A track record of peer-reviewed publications demonstrating experience in COAs, observational research, and/or health economic modeling.
• Strong communication skills, both verbal and written, including the ability to effectively present to both internal and external audiences
• Results oriented and excellent analytic and project management skills. 
• A strong sense of urgency and commitment to patients

This is a hybrid eligible role requiring at least 3 days on-site in Boston office.

#LI-KM3

#LI-Hybrid

Company Information

Job Description

The Senior Medical Director, Patient Safety, Disease Area Safety Head (DASH) will lead all safety and benefit-risk related activities for products within the role's Disease-area and/or Franchise, including pre-franchise products from first in-human clinical trials, into and throughout commercialization. This role will assist Global Patient Safety (GPS) Leadership in ensuring the consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Directly and/or via oversight of direct reports, the role will lead pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with the program specific Clinical Teams, Medical Affairs, and Partners (as applicable) to proactively assess and address potential and identified safety issues for each product throughout the product life cycle.

Key Duties and Responsibilities:

• Provides leadership and oversight of Safety Team(s) for products within assigned therapeutic area(s), including pre-FIH activities, benefit-risk assessment, and strategy for DSTs.

• Coordinates and oversees safety signals detection, in accordance with Vertex signal detection practices.

• Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, as needed.

• Collaborates with NDA teams in support of submissions, specifically leading development of any SCS, CLO, Label and Risk Management Plan (RMP) or equivalent documents.

• Collaborates with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies.

• Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (D/PSURs), IND packages, as well as NDA and IND, MAA Annual Safety Reports.

• Provides review and safety-specific input for labeling documents.

• Collaborates with Regulatory Affairs to develop responses to safety related regulatory agency inquiries.

• Provides and oversees medical review of aggregate and individual post-marketing and clinical trial AE reports, in accordance with GPS review practices.

• Conducts medical evaluation of relevant safety information from Toxicology, Non-Clinical studies and Product Quality sources.

• Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, Analysis Plan, IB, ICF and IDMC Charter.

• Reviews and provides oversight in the analysis of safety data from on-going and completed clinical trials and Study Reports.

• Provides contributory to Partner /Affiliate agreements and interactions, as needed.

• Serves as Subject Matter Expert in departmental activities, SOP development.

• Facilitates the growth and development of staff and direct reports.

Knowledge and Skills:

• Broad and comprehensive knowledge of General Medicine

• Extensive knowledge of GCP, ICH and Global regulations

• Strong leadership skills with the ability to communicate effectively in a matrix environment

• Experience in the critical evaluation and interpretation of data, with ability to synthesize into coherent messaging

• Comprehensive knowledge of Benefit-Risk strategies and decision-making

• Ability to multi-task, adeptly handling multiple demands

Education and Experience:

• Doctorate in Medicine (M.D.) required

• 7+ years of work experience with some experience in Pharmacovigilance and 5 years of supervisory/management experience, or the equivalent combination of education and experience

Company Information

Job Description

Vertex is seeking a detail-oriented Package Engineering Senior Specialist with technical expertise in pharmaceutical packaging, process development and continuous improvement initiatives. The ideal candidate will provide technical support in packaging operations, working with cross functional teams in a fast-paced environment.  Candidate will need to ensure resolution of technical issues with Contract Manufacturers and Distribution Centers.  They will support projects with on-time review and implementation of documentation, and change controls. Candidate should have excellent problem solving, organizational, interpersonal, oral, and written communication skills, and experience with technical writing, cGMP and regulatory CMC requirements.

KEY RESPONSIBILITIES:

• Provides technical support on Packaging processes to Package Engineering and cross functional teams
• Author and/or review validation and change control documents such as master batch records, protocols, reports and change requests.
• Experience in software systems for validation protocols, change controls, CAPAs and Deviations.
• Experience with common primary, secondary, and tertiary packaging materials
• Supports packaging projects and process improvement efforts (IE New Product Introductions, validations, equipment installation, IQ/OQ/PQ protocol development and execution
• Ability and flexibility to work globally in a virtual work environment
• Excellent project management experience
• Ability to multitask to effectively manage multiple activities and projects
• Ability to collaborate with and communicate results to relevant stakeholders
• Strong analytical, problem solving and communication skills
• Develops solid working relationships with relevant technical individuals or teams at contract manufacturing sites
• Will require travel periodically to contract manufacturing plants to support process performance or to troubleshoot manufacturing issues 
• Complies with all Quality, Regulatory, Health, Safety, and Environmental responsibilities for the position
• Supports the responsibilities of the Packaging LCM team in projects related to packaging technology, sustainability, and industry activity
• Experience or certification in LEAN and/or Six Sigma practices is a plus

Education and Experience:

• Typically requires Degree in Packaging, Biomedical, Mechanical, Chemical, or Industrial Engineering or a related field.
• Minimally requires 3 years of experience or the equivalent combination of advanced education and experience.

Required Knowledge/Skills

• Advanced knowledge of cGMP’s and associated CMC regulatory considerations in a pharmaceutical environment
• Fundamental understanding and application of validation processes (IQ/OQ/PQ/PV)
• Solid communication, collaboration and team building skills; ability to connect with all levels of the organization
• Demonstrated ability to manage multiple projects concurrently, and flexibility to accommodate changes in responsibilities or project priorities

Other Requirements

• Ability to travel domestic and international. (Approximately 25%)

Company Information

Job Description

The Executive Medical Director, Patient Safety/Head Medical Safety and Risk Management will oversee all safety and benefit-risk related activities of the GPS Physician (Disease-area Safety Heads, DST Chairs) and the Aggregate Report Risk Management (ARRM) Groups within the Vertex Global Patient Safety (GPS) Department. As a member of the GPS Senior Leadership Team, the role will contribute to ensuring consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Overseeing the GPS DASH/DST teams across therapeutic areas, the role will ensure consistent conduct and timely execution of Benefit-Risk activities by GPS DASH/DST teams, including pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with leaders from cross-functional teams on the successful achievement of key strategic activities, initiatives and deliverables.

Key Duties and Responsibilities:

• Provides leadership and oversight of DASH/Disease-area Safety Team(s) (DST) conduct, for all products across the Vertex Portfolio, including pre-FIH activities, key benefit-risk assessment, and providing strategy for DSTs to meet goals and objectives.

• Coordinates and oversees the consistent and timely review of safety data for identification of new safety signals, in accordance with Vertex signal detection practices.

• Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, both pre-approval and post-approval, as needed.

• Collaborates with NDA teams assessment, strategy and execution of key Regulatory Authority documents in support of submissions, specifically leading safety content of key Modules (SCS, CLO, Labelling) and development of any Risk Evaluation and Mitigation Strategy (REMS), Risk Management Plan (RMP) or equivalent documents.

• Collaborates with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies, as needed.

• Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (DSURs, PSURs/PBRERs), IND packages, as well as NDA and INDs.

• Provides review and safety-specific input for labeling documents, including IB, CCDS, USPI, SmPC and other local labels, as applicable.

• Collaborates with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries.

• Provides and oversees medical review of aggregate and/or individual post-marketing and clinical trial adverse event reports, in accordance with GPS review practices.

• Oversees medical evaluation of other relevant non-AE/SAE related safety information, such as from Toxicology, Non-Clinical studies and Product Quality sources.

• Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, Statistical Analysis Plan, IB, ICF and IDMC Charter.

• Reviews and provides oversight in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.

• Reviews and provides oversight of safety sections of clinical study reports.

• Provides a contributory role in Partner /Affiliate agreements and interactions, as needed.

• Serves as Subject Matter Expert in departmental development activities including SOP and Work Instructions development.

• Leads Medical staff and liaise with Operations leads regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.

• Leads and guides direct reports, regarding the scope of DASH/DST Chair Physician responsibilities, and the provision of sound medical input for all pre-marketing and post-marketing activities.

• Facilitates the growth and development of staff and direct reports.

Knowledge and Skills:

• Extensive knowledge of GCP, ICH and Global regulations.

• In-depth and comprehensive knowledge of General Medicine.

• Strong leadership skills with the ability to communicate effectively in a matrix environment.

• Experience in the critical evaluation and interpretation of data, with ability to synthesize into clear, coherent messaging.

• Extensive knowledge of Benefit-Risk strategies and decision-making.

• Ability to multi-task, adeptly handling multiple demands.

Education and Experience:

• MD, DO or equivalent ex-US medical degree

• 12+ years of work experience with experience in Pharmacovigilance and 7 years of supervisory/management experience, or the equivalent combination of education and experience

Company Information