<h3>Job Description</h3>
Job Description
Location: On-Site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami FL locations
About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
<ul>
<li>HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.</li>
</ul>
<ul>
<li>HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.</li>
</ul>
<ul>
<li>HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.</li>
</ul>
Colorectal Cancer (CRC)
<ul>
<li>HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.</li>
</ul>
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role:
The Manager, Quality Assurance will report to Quality Assurance leadership and support GMP compliance related to drug substance and drug product manufacturing processes. This role will contribute to quality assurance activities, ensuring compliance with applicable regulations and industry standards. The Manager will assist in inspection readiness efforts, support batch review and release processes, and work cross-functionally to maintain and improve quality systems.
Role and Responsibilities:
<ul>
<li>Support the development, implementation, and maintenance of GMP quality systems, including policies, procedures, and risk assessments in alignment with global health authority regulations (FDA, EMA, ICH, etc.)</li>
<li>Assist in ensuring GMP compliance at Contract Manufacturing Organizations (CMOs) by providing sponsor oversight and supporting clinical and commercial manufacturing activities</li>
<li>Participate in inspection readiness activities, including documentation preparation and coordination for internal audits and regulatory inspections</li>
<li>Assist with investigations, root cause analysis, risk assessments, and corrective and preventive actions (CAPAs) to ensure timely resolution of quality-related issues</li>
<li>Support internal QA batch review and release processes to ensure compliance with applicable regulations</li>
<li>Review and help maintain controlled documents, including Standard Operating Procedures (SOPs), to align with regulatory requirements and industry best practices</li>
<li>Collaborate with cross-functional teams to achieve quality and compliance objectives</li>
<li>Assist in tracking and maintaining quality metrics and performance indicators</li>
<li>Perform other duties as assigned to support Quality Assurance initiatives</li>
<li>All other duties as assigned</li>
</ul>
Experience, Education and Specialized Knowledge and Skills:
<ul>
<li>Bachelor’s degree in chemistry, biochemistry, life sciences, biotechnology, or a related field</li>
<li>Minimum of 5+ years of relevant experience in the pharmaceutical or biotechnology industry, with a focus on GMP manufacturing</li>
<li>Experience with biologics essential; familiarity with analytical laboratory testing is a plus</li>
<li>Experience working with e-QMS systems (e.g., MasterControl, TrackWise) to execute quality processes</li>
<li>Understanding of GMP requirements for clinical and commercial biologics manufacturing</li>
<li>Experience supporting audits and regulatory inspections is a plus</li>
<li>Strong organizational skills with the ability to handle multiple projects in a fast-paced environment</li>
<li>Excellent attention to detail, problem-solving abilities, and a strong sense of work ethic</li>
<li>Effective communication and collaboration skills, with the ability to work cross-functionally</li>
<li>Fluency in Mandarin is a plus</li>
</ul>
The pay range for this role is $122,000-$143,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at <a href="mailto:recruiting@smmttx.com" target="_blank">recruiting@smmttx.com</a> to obtain prior written authorization before referring any candidates to Summit.

Manager, Quality Assurance (GMP)

<h3>Job Description</h3>
Job Description
Location: On-Site 4 days per week at our Princeton, NJ or Miami FL locations
About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
<ul>
<li>HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.</li>
</ul>
<ul>
<li>HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.</li>
</ul>
<ul>
<li>HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.</li>
</ul>
Colorectal Cancer (CRC)
<ul>
<li>HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.</li>
</ul>
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role: 
The Clinical Research Associate (CRA) is responsible for Supporting all aspects of Clinical Trial Management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under direction from Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial. 
Role and Responsibilities: 
<ul>
<li>
Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables 
</li>
</ul>
<ul>
<li>
Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites 
</li>
</ul>
<ul>
<li>
Initiates and builds solid professional relationships with clinical site staff 
</li>
</ul>
<ul>
<li>
Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data 
</li>
</ul>
<ul>
<li>
Creation and development of study trackers 
</li>
</ul>
<ul>
<li>
Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings 
</li>
</ul>
<ul>
<li>
Responsible for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc. 
</li>
</ul>
<ul>
<li>
Responsible for reviewing assigned study related plans, processes, agreements, and guidelines 
</li>
</ul>
<ul>
<li>
Following and implementing assigned study related plans, processes, agreements, and guidelines 
</li>
</ul>
<ul>
<li>
Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met 
</li>
</ul>
<ul>
<li>
Reviews and approves essential document packages to enable timely site activations. 
</li>
</ul>
<ul>
<li>
Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete 
</li>
</ul>
<ul>
<li>
Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed 
</li>
</ul>
<ul>
<li>
Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary 
</li>
</ul>
<ul>
<li>
Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF 
</li>
</ul>
<ul>
<li>
Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs 
</li>
</ul>
<ul>
<li>
Ensures the study is “inspection ready” contemporaneously 
</li>
</ul>
<ul>
<li>
Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate 
</li>
</ul>
<ul>
<li>
All other duties as assigned 
</li>
</ul>
Experience, Education and Specialized Knowledge and Skills: 
<ul>
<li>
Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred 
</li>
</ul>
<ul>
<li>
A minimum of 3+ years of clinical research experience in conducting clinical trials 
</li>
</ul>
<ul>
<li>
Prior phase II or III experience required 
</li>
</ul>
<ul>
<li>
A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process 
</li>
</ul>
<ul>
<li>
Experience with clinical studies oncology and / or rare diseases a plus 
</li>
</ul>
<ul>
<li>
Sophisticated understanding and highly skilful utilization of Microsoft Apps such as Outlook, Word, Excel, and Teams 
</li>
</ul>
<ul>
<li>
Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%) 
</li>
</ul>
<ul>
<li>
Tenacity to work in a fast-paced team environment 
</li>
</ul>
<ul>
<li>
Enjoys building relationships with KOLs and site personnel. Willing to travel to establish relationships 
</li>
</ul>
<ul>
<li>
Ability to successfully engage and work collaboratively with global team members/colleagues 
</li>
</ul>
<ul>
<li>
Ability to support building and delivery of patient enrolment strategies 
</li>
</ul>
<ul>
<li>
Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy and enthusiasm to deliver the program objectives. 
</li>
</ul>
<ul>
<li>
Ability to review and assess clinical data 
</li>
</ul>
<ul>
<li>
Possesses excellent planning, time management &amp; coordination skills. 
</li>
</ul>
<ul>
<li>
Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs 
</li>
</ul>
<ul>
<li>
Experience in working in a small organization a plus 
</li>
</ul>
<ul>
<li>
Excellent written and oral communication skills 
</li>
</ul>
The pay range for this role is $97,000-$114,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at <a href="mailto:recruiting@smmttx.com" target="_blank">recruiting@smmttx.com</a> to obtain prior written authorization before referring any candidates to Summit.

Clinical Research Associate

<h3>Job Description</h3>
Job Description
Location: On-Site 4 days per week at our Princeton, NJ or Miami FL locations
About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
<ul>
<li>HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.</li>
</ul>
<ul>
<li>HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.</li>
</ul>
<ul>
<li>HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.</li>
</ul>
Colorectal Cancer (CRC)
<ul>
<li>HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.</li>
</ul>
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role: 
The Clinical Trial Associate (CTA) is responsible for supporting the daily workflow of clinical operations activities. They will provide administrative support to study teams throughout the study. Key administrative activities include, but are not limited to, managing meeting invitations, creating agendas and meeting minutes, study document filing, maintaining study trackers, and oversight of the eTMF and vendors.? 
Role and Responsibilities: 
<ul>
<li>
Provides administrative support to the clinical operations study team, including managing meeting logistics, creating agendas, and drafting meeting minutes 
</li>
</ul>
<ul>
<li>
Executes tasks as assigned by the Clinical Operations Manager, including study budget forecasting and tracking 
</li>
</ul>
<ul>
<li>
Ensures accurate and timely documentation, including eTMF management, study contracts and financial records in compliance with ICH-GCP, company policies and regulatory requirements 
</li>
</ul>
<ul>
<li>
Coordinates clinical operations activities across cross-functional teams, including contract management, vendor oversight, site start-up and activation, protocol deviation 
</li>
</ul>
<ul>
<li>
Creates and maintains study-related materials, such as country and site binders and tracks trial milestones 
</li>
</ul>
<ul>
<li>
Ensure the eTMF is being maintained up-to-date and all essential documents are appropriately filed in the eTMF 
</li>
</ul>
<ul>
<li>
Collaborates with CROs to ensure accurate data collection and entry into the CTMS and EDC 
</li>
</ul>
<ul>
<li>
Attend and contribute to team meetings, taking detailed meeting minutes 
</li>
</ul>
<ul>
<li>
Supports clinical study management as delegated by Clinical Operations managers, including liaison with external vendors 
</li>
</ul>
<ul>
<li>
Actively participates in process improvement initiatives to enhance clinical operations efficiency 
</li>
</ul>
<ul>
<li>
All other duties as assigned 
</li>
</ul>
Experience, Education and Specialized Knowledge and Skills: 
<ul>
<li>
Bachelor’s degree in biological sciences, health sciences or medical field, or equivalent combination of education and experience 
</li>
</ul>
<ul>
<li>
2+ Years of experience in clinical study environment within CRO or Pharmaceutical company 
</li>
</ul>
<ul>
<li>
Strong understanding of the phases of clinical drug development and clinical operation processes from start-up to close-out. 
</li>
</ul>
<ul>
<li>
Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines 
</li>
</ul>
<ul>
<li>
Ability to organize, prioritize tasks, identify and resolve issues efficiently. Manage multiple tasks effectively and follow through on assigned tasks. 
</li>
</ul>
<ul>
<li>
Ability to receive general instructions on new assignments and perform routine work independently. Collaborate and work effectively within a team and within a multi-disciplinary environment. 
</li>
</ul>
<ul>
<li>
Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form 
</li>
</ul>
<ul>
<li>
Attention to detail, accuracy and confidentiality 
</li>
</ul>
<ul>
<li>
Critical thinking, problem solving, ability to work independently 
</li>
</ul>
<ul>
<li>
Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader) and database software (eTMF, EDC) to support operation of clinical trial databases and electronic filing methods 
</li>
</ul>
<ul>
<li>
Work in a fast-paced, demanding and collaborative environment 
</li>
</ul>
<ul>
<li>
Demonstrate high ethical standards for honesty, truthfulness and integrity 
</li>
</ul>
The pay range for this role is $97,000-$114,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at <a href="mailto:recruiting@smmttx.com" target="_blank">recruiting@smmttx.com</a> to obtain prior written authorization before referring any candidates to Summit.

Clinical Trial Associate

<h3>Job Description</h3>
Job Description
Location: On-Site 4 days per week at our Princeton, NJ or Miami FL locations
About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
<ul>
<li>HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.</li>
</ul>
<ul>
<li>HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.</li>
</ul>
<ul>
<li>HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.</li>
</ul>
Colorectal Cancer (CRC)
<ul>
<li>HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.</li>
</ul>
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role: 
The Director will serve as a cross-functional study team lead for the clinical development program, responsible for delivering all clinical trial operational activities across multiple studies for Summit Therapeutics. This role should demonstrate strong matrix management skills, confidence in working independently, and have proven ability to champion a team to deliver on key study milestones. In addition, the Director will be responsible for assisting in study design, planning, and execution of clinical trials while operating within budget and per established timelines, regulatory and quality standards. 
Role and Responsibilities: 
<ul>
<li>
Study Execution: Oversee and manage the execution of one or more phase 1-3 clinical trials. Management of all clinical operations support vendors contracted for the assigned study(ies), including budgets and timelines oversight, performance management, risk management, and issue resolution 
</li>
</ul>
<ul>
<li>
Study Planning and Management: Establish and coordinate all ongoing study management activities, including leading the cross-functional study team development of an overall study execution plan to deliver key study deliverables. Daily activities may include updating/reviewing study documents (protocols, informed consent forms, clinical study reports, site facing material, etc.), monitoring study status across internal functions and external vendors, anticipating and mitigating risks within the timeline, quality, and study budget 
</li>
</ul>
<ul>
<li>
Study Team Meetings: Lead team meetings, as assigned, both internally and with multiple vendors. Attend Project Team and/or Executive Team Meetings, as required 
</li>
</ul>
<ul>
<li>
Study Site Management: Cultivate and maintain strong relationships with investigators and trial site administrators; Organize investigator meetings as needed; contributes to the development of abstracts, presentations, and manuscripts for studies 
</li>
</ul>
<ul>
<li>
Clinical Trial Budgeting: Maintain oversight of clinical operations budget, including regular forecasting and internal reporting to management and finance; review vendor invoices against the scope of work and work completed to date; identify and communicate discrepancies 
</li>
</ul>
<ul>
<li>
Quality Control: Support the development of quality control processes and study plans to ensure that clinical activities are compliant with Good Clinical Practice and regulatory guidelines. Ensure execution of trials according to the study protocol and procedures, SOPs, ICH/GCP, FDA, EMEA, NICE, and other relevant policies and regulations 
</li>
</ul>
<ul>
<li>
Supply Chain Management: Support clinical and non-clinical supplies planning for trial execution. 
</li>
</ul>
<ul>
<li>
Truth Seekers, who are detailed, rational, and humble problem solvers 
</li>
</ul>
<ul>
<li>
Individuals Who Inspire Excellence in themselves and those around them 
</li>
</ul>
<ul>
<li>
High-quality executors, who execute against goals and milestones with quality, precision, and speed 
</li>
</ul>
<ul>
<li>
All other duties as assigned 
</li>
</ul>
Experience, Education and Specialized Knowledge and Skills: 
<ul>
<li>
BA/BS required in a scientific/medical field preferred 
</li>
</ul>
<ul>
<li>
A minimum of 10+ years of experience in managing global clinical trials at all stages of development 
</li>
</ul>
<ul>
<li>
Experience in rare/orphan disease areas is preferred 
</li>
</ul>
<ul>
<li>
Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities 
</li>
</ul>
<ul>
<li>
Demonstrated successful management and oversight of CROs and other service providers 
</li>
</ul>
<ul>
<li>
Deep understanding of clinical trial design, protocol development/ review, and running the clinical trial meetings 
</li>
</ul>
<ul>
<li>
Significant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities 
</li>
</ul>
<ul>
<li>
Organize and/or participate in specific study-related advisory committees (e.g., steering committee, data monitoring committees, adjudication committees) 
</li>
</ul>
<ul>
<li>
Strong vendor management experience required 
</li>
</ul>
<ul>
<li>
Experience in the management and maintenance of EDC, CTMS, IxRS, ePRO, etc. 
</li>
</ul>
<ul>
<li>
Experience in Quality Assurance, SOP and Study Plans writing, CAPA preparation, and closure 
</li>
</ul>
<ul>
<li>
Experience with a submission-ready eTMF, regulatory inspections and/or inspection-readiness activities 
</li>
</ul>
<ul>
<li>
Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations 
</li>
</ul>
<ul>
<li>
Strong project management experience and skills is preferred 
</li>
</ul>
<ul>
<li>
Demonstrate strong leadership and matrix management skills, ability to multi-task in a dynamic and fast-paced environment 
</li>
</ul>
<ul>
<li>
Strong interpersonal, negotiation, influencing, problem-solving skills 
</li>
</ul>
<ul>
<li>
Excellent written and verbal skills required 
</li>
</ul>
<ul>
<li>
Willing to travel domestically and internationally up to 20% of the time 
</li>
</ul>
<ul>
<li>
Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable 
</li>
</ul>
<ul>
<li>
Strong computer and database skills 
</li>
</ul>
<ul>
<li>
Attention to detail, accuracy and confidentiality 
</li>
</ul>
<ul>
<li>
Clear and concise oral and written communication skills 
</li>
</ul>
<ul>
<li>
Excellent organizational skills 
</li>
</ul>
<ul>
<li>
Critical thinking, problem solving, ability to work independently. 
</li>
</ul>
<ul>
<li>
Must be able to effectively multi-task and manage time-sensitive and highly confidential documents. 
</li>
</ul>
<ul>
<li>
Communicate effectively and articulate complex ideas in an easily understandable way 
</li>
</ul>
<ul>
<li>
Prioritize conflicting demands. 
</li>
</ul>
<ul>
<li>
Work in a fast-paced, demanding and collaborative environment 
</li>
</ul>
The pay range for this role is $190,000-$230,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at <a href="mailto:recruiting@smmttx.com" target="_blank">recruiting@smmttx.com</a> to obtain prior written authorization before referring any candidates to Summit.

Director, Clinical Operations

<h3>Job Description</h3>
Job Description
Now Hiring: Dispatcher | Help Keep Our Resort Operations Running Smoothly!
Are you highly organized, calm under pressure, and great at keeping communication flowing? Do you enjoy being at the center of operations—making sure the right people get the right information at the right time? If so, we’d love to meet you!
We’re looking for a Dispatcher to support our Facilities and Resort Operations teams. In this role, you’ll coordinate daily maintenance work orders, communicate across departments, and help ensure fast, efficient responses to guest needs. If you thrive in a dynamic, fast-paced environment, this is the role for you!
What You'll Do:
<ul>
<li>
Assign and distribute daily maintenance work orders to technicians and field staff
</li>
<li>
Assist leadership teams in creating daily and weekly technician assignments and maintenance boards
</li>
<li>
Provide friendly, professional support to guests and team members
</li>
<li>
Monitor work orders and report delays or unresolved tasks to management
</li>
<li>
Answer and dispatch phone and radio communications clearly and professionally
</li>
<li>
Manage key distribution for staff and vendors
</li>
<li>
Prepare and deliver daily operational reports
</li>
<li>
Support office tasks such as printing materials, laminating signage, and updating unit phone plates
</li>
<li>
Assist with opening/closing procedures and help manage out-of-service room statuses
</li>
<li>
Communicate effectively with upper management to maintain smooth operations
</li>
<li>
Respond to emergencies and support high-volume periods as needed
</li>
<li>
Collaborate closely with housekeeping, maintenance, and other departments
</li>
<li>
Attend required meetings and follow company policies and procedures
</li>
<li>
Perform additional duties as assigned
</li>
</ul>
What We’re Looking For:
<ul>
<li>
Strong attention to detail and accuracy in following procedures
</li>
<li>
Excellent communication and teamwork skills
</li>
<li>
Ability to interpret basic data and recognize trends
</li>
<li>
Comfortable working independently in a fast-paced, service-focused environment
</li>
<li>
Proficiency in Microsoft Office and basic inspection/feedback tools
</li>
<li>
Bilingual ability strongly preferred
</li>
<li>
Strong multitasking and organizational skills
</li>
<li>
Professional, calm, and guest-focused demeanor
</li>
</ul>
Experience &amp; Education:
<ul>
<li>
High School Diploma or GED required
</li>
<li>
At least 1 year of hospitality experience preferred (resort/timeshare experience a plus)
</li>
<li>
Experience in dispatching, maintenance coordination, or housekeeping support is highly desirable
</li>
<li>
Strong phone, radio, and in-person communication skills
</li>
</ul>
Why You’ll Love This Role:
<ul>
<li>
Be the central hub that keeps resort operations running efficiently
</li>
<li>
Work closely with multiple departments and leadership teams
</li>
<li>
Grow your skills in communication, coordination, and resort operations
</li>
<li>
Join a supportive, team-oriented work environment
</li>
</ul>

Dispatcher - Weston, Vacation Village Resort

<h3>Job Description</h3>
Job Description
Well established Pest Control company, family type environment, immediate opening for technicians. Full time/permanent positions. No experience necessary. Applicant must have clean driving record. Be able to lift 40-50 pounds. Have good customer service skills, good communication skills, clean background is a must. Clean cut appearance is a must. Must have basic organizing skills. Must be able to complete daily route and be a great communicator. No experience needed we will train the right individual. Paid holidays after 6 months, Paid time off after 1 year. Hourly/salary pay and commissions. Company vehicle, company phone. 401k option. We promote from within, our company and our team works well together to ensure everyone can reach their full potential. Employees will enjoy working in a cheerful, fun atmosphere. Must attach a resume for consideration. Equal opportunity employer
Company DescriptionSmall business where employees are recognized for their contributions and efforts. 
<h3>Company Description</h3>
Small business where employees are recognized for their contributions and efforts.

Pest Control and Termite Control Technicians

<h3>Job Description</h3>
Job Description
Position: Canvassing Team
Do you have a Canvassing Team are you looking for a home? High Pay + Vehicle Provided – no selling involved.
Responsibilities: • Canvass neighborhoods to find old original windows, doors, and damage roofing • Schedule FREE estimate appointments for windows, doors, bathrooms and roofing • Work outdoors and engage directly with homeowners
Qualifications: • Outgoing personality • Strong communication skills • Driven to achieve goals
Compensation: • Salary, Commission &amp; Bonus • 5-day work schedule (No Weekends!) • Full training provided • Career growth opportunities
Apply Now! Send your phone number and updated resume. Qualified applicants will be contacted for a phone interview.
 #hc215593

Canvass Leaders & Team Members Start ASAP! Top Pay + Company Vehicle

<h3>Job Description</h3>
Job Description
Join Vacation Village by Vacatia and Help Shape the Future!
Location: Events through out Central and South Florida
At Vacation Village Resorts, we are committed to providing our employees with a workplace environment that is safe, inclusive, productive, challenging, rewarding, and fun. When you become a member of our family, you join a company that is as passionate about its employees as it is about its customers and owners.
The Field Package Sales Agent is responsible for generating leads and selling vacation packages at various events. This includes completing the Acceptance Form with all necessary signatures and processing payments using a provided tablet with a booking application. Agents may also support the on-site Event Team Leader by assisting with pitches, detailing package components, personalizing vacations for customers, distributing marketing materials, maintaining a clean exhibit space, and covering for staff breaks.
Your Impact
<ul>
<li>
Lead Generation &amp; Sales: Proactively identify, cultivate, and convert high-quality leads into successful package sales by understanding needs, presenting solutions, and closing deals.
</li>
<li>
Paperwork Processing: Accurately and efficiently process all necessary documentation for package sales, ensuring compliance with company policies and legal requirements.
</li>
<li>
Information Management (Tablet-Based): Utilize a tablet for seamless uploading and downloading of sales activities, customer data, and package details, ensuring real-time updates and efficient data management.
</li>
<li>
Additional Tasks: Perform assigned tasks, including training, meetings, or special projects, contributing to the sales team's and organization's success.
</li>
</ul>
What You Bring
<ul>
<li>
Lead generation or sales background required
</li>
<li>
Goal-oriented, motivated, outgoing, friendly, tactful, well-organized, professional, and positive
</li>
<li>
Must work weekends, holidays, and extended hours
</li>
<li>
Unrestricted Driver’s License and Ability to travel to multiple locations
</li>
<li>
Excellent communication, interpersonal, and problem-solving skills
</li>
<li>
Ability to meet and listen to people
</li>
<li>
Minimum of 1 year in customer service, sales, concierge or field marketing, preferably in hospitality, vacation ownership, or resorts
</li>
<li>
Customer interaction, sales, and closing experience preferred
</li>
</ul>
Join Vacatia and Help Shape the Future of Resort Rentals
If you're ready to use your expertise to drive impact and support high-growth timeshare sales programs in a dynamic hospitality environment, we want to hear from you.
Apply now and bring your skill set to where insight meets hospitality!

Event Travel Promotions Specialist

<h3>Job Description</h3>
Job Description
Position: Show and Event Manager for Big Box Locations Qualifications: • Retail Marketing Manager Experience • You must be comfortable walking up to customers and engaging them in conversation Responsibilities: • Approach customers who are shopping in the store as they pass by the Kiosk • Discuss services/products Windows, Doors, Roofing generate interest and schedule appointments • Hire Train and manage retail marketing reps to engage customers and offer free in home presentations Experience: • 5 + years of Retail Marketing (Brand Ambassador) Management experience. Position Offers: • Competitive Compensation: • Career Growth • Stable Environment • Advancement opportunities To Apply: All applicants must submit their updated resume along with their contact phone number.
 #hc215586

Show and Event Manager for Big Box Locations

<h3>Job Description</h3>
Job DescriptionARE YOU PASSIONATE ABOUT LEADING A TEAM, AND DRIVING EXCELLENT CUSTOMER EXPERIENCES? IF SO, WE WANT TO HEAR FROM YOU TODAY! Position:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Customer Service Team Lead (CSTL) Compensation:&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; $20/HR - Hourly Base Rate + Bonus(es) &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Benefits offered:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 401k w/employer match, medical, vision, dental, disability/life, paid holidays, paid time off (PTO), service time awards and more! Location:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; On-Site / Plantation, FL 33313 Schedule:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Mon-Fri 9A M – 6:00 PM&nbsp; /&nbsp; 1-day a week closing shift of 11 AM -8:30 PM TBD About Us: Since 2015, Lighthouse has been a leader in the debt settlement industry, helping thousands of individuals and families find financial freedom.&nbsp; We help families every day reduce their credit card debt by nearly half of what they owe.&nbsp; The CSTL will be responsible to help manage the day-to-day operations of the Plantation Campus, with a focus on the Customer Service Team, cancellation metrics, draft rates and client experience campaign(s).&nbsp; The CSTL will also be capable and available to receive and/or handle any escalation calls from our clients who have enrolled into our certified and compliant debt settlement program and may need some additional support, assisting them with their questions or needs.&nbsp; Industry experience is not required.&nbsp; Training is provided. Bilingual preferred, not necessary. Customer Service Site Manager Responsibilities:
<ul>
<li>Assists Director with managing, monitoring, coaching, developing, motivating, and mentoring representatives on campus, with a focus on Customer Service.&nbsp;&nbsp;&nbsp; </li>
<li>Processes requests, prepares correspondence, and fulfills clients or creditors needs to ensure client satisfaction,&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </li>
<li>Assists in resolving complex customer problems, and provides education for corrective actions and analysis, </li>
<li>Work with vendor partners (Global / Fortress) to maintain client’s accounts,&nbsp; </li>
<li>Provides efficient and courteous telephone service to client and creditor inquiries, </li>
<li>Assumes responsibility for escalated issues and performance of team members, </li>
<li>Determines proper processes and procedures for fulfilling internal/external client and creditor needs related to the settlement process, </li>
<li>Provides coaching and instruction in a supportive fashion to the team pertaining to product knowledge, leadership/management development and skills-based training, </li>
<li>Responsible for all disciplinary actions of the team, other than terminations, </li>
<li>Responsible for disciplinary actions occurring while monitoring team members, or in the Director’s absence, </li>
<li>Handles escalated calls and client/creditor issues, makes recommendations to upper management,&nbsp;&nbsp; </li>
<li>Ensures complete and efficient client interactions,&nbsp; </li>
<li>Identifies problem areas and works with the representative, manager and/or trainer to identify training opportunities, </li>
<li>Creates a safe, positive and support environment for the learn, </li>
<li>Researches, reviews, and investigates client and creditor documentation and client files, </li>
<li>Relies on experience and decision-making skills to plan and accomplish goals, </li>
<li>Performs a variety of complicated tasks while working under general supervision and able to work independently,&nbsp; </li>
<li>Helps in the creation of training tools/training material and handbooks, </li>
<li>Any other tasks as assigned by the upper management. </li>
<li>Will be part of the interviewing and hiring process, </li>
</ul>
 Customer Service Site Manager Required Skills:
<ul>
<li>Highschool diploma, general education degree or equivalent, and 3 years of related industry experience </li>
<li>Previous experience credit and/or collections, financial, or call center environment, </li>
<li>Able to communicate effectively both orally and in written form, </li>
<li>Knowledge and use of PC Systems and MS Office applications is a must, </li>
<li>Competency in a service organization environment, </li>
<li>Ability to work independently, </li>
<li>Self-motivated, willingness to constantly improve processes, </li>
<li>Attention to detail and be able to multi-task and prioritize work on a daily basis, </li>
<li>Strong knowledge of all operational processes and conflict resolution, </li>
<li>Strong leadership skills, </li>
<li>Demonstrates flexibility/adaptability,</li>
<li>Possess excellent decision-making skills, </li>
<li>Satisfactory attendance, </li>
<li>Able to work in the office (This is not a work from home position), </li>
<li>The ability to work a scheduled shift of 45 hours or more depending on tasks/projects and other assignments. </li>
</ul>
Many of the successful hires we have made over the past few years have come from call center environments. We provide an in-house training program. No experience necessary. Job Type: Full-time Pay: $20/HR + Quarterly Bonus(s) Benefits:
<ul>
<li>401(k)</li>
<li>401(k) matching</li>
<li>Dental insurance</li>
<li>Disability insurance</li>
<li>Flexible schedule</li>
<li>Health insurance</li>
<li>Health savings account</li>
<li>Life insurance</li>
<li>Paid time off</li>
<li>Paid training</li>
<li>Vision insurance</li>
</ul>
Schedule:
<ul>
<li>Monday to Friday 9-6 PM</li>
</ul>
Supplemental pay types:
<ul>
<li>Bonus(es)</li>
<li>Spiff(s)</li>
</ul>
Ability to commute/relocate:
<ul>
<li>Plantation, FL 333133: Reliably commute or planning to relocate before starting work (Required)</li>
</ul>
Work Location: One location #ZR7 By submitting your interest in this position, you provide your written express consent and agree that VentureTech Solutions may contact you regarding employment opportunities using autodialing, text and pre-recorded messaging for convenience via telephone, mobile device (including SMS and MMS - charges may apply depending on your carrier, not by us, messaging frequency varies; text STOP to cancel), even if your telephone number is currently listed on any internal, corporate, state or federal Do-Not-Call list. VentureTech Solutions, LLC provides recruitment services for Lighthouse Financial Solutions.&nbsp;
Powered by JazzHR
NvA24oxtLT
Company DescriptionDebt relief companies often get a bad rap, but that’s not entirely undeserved. Too often, desperate consumers get lured in by opportunistic companies out to make a quick buck. They pay exorbitant fees before any work gets done, and then often lose those fees without seeing any results. Lighthouse Finance Solutions believes our customers’ needs should always come first. That’s why we make sure that settlement is the right choice before we let you sign up for a plan. It’s also why we don’t accept fees until we settle your debt. It’s the way debt relief should work and it follows the high standards set by the American Fair Credit Council. At Lighthouse Finance Solutions, we’re here to light your way forward to safer financial waters. We help you end your debt problems quickly without judgment, then we help you recover just as quickly so you can reestablish good credit. 
<h3>Company Description</h3>
Debt relief companies often get a bad rap, but that’s not entirely undeserved. Too often, desperate consumers get lured in by opportunistic companies out to make a quick buck. They pay exorbitant fees before any work gets done, and then often lose those fees without seeing any results.\r\n\r\nLighthouse Finance Solutions believes our customers’ needs should always come first. That’s why we make sure that settlement is the right choice before we let you sign up for a plan. It’s also why we don’t accept fees until we settle your debt. It’s the way debt relief should work and it follows the high standards set by the American Fair Credit Council.\r\n\r\nAt Lighthouse Finance Solutions, we’re here to light your way forward to safer financial waters. We help you end your debt problems quickly without judgment, then we help you recover just as quickly so you can reestablish good credit.

67,476 Insurance Jobs in Hialeah, FL, USA