Qureos Mentor

Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. They focus on addressing modern market realities and enhancing the delivery of important therapies to patients through advanced technologies and business practices. With a commitment to collaboration and specialized expertise, Syneos Health supports biopharmaceutical companies in navigating the complexities of clinical development and commercialization.

<div>Regulatory Labeling Manager &ndash; Artwork Development and Source Text Review(NA and LATAM Only)
<div>Syneos Health&reg; is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver &ndash; for one another, our customers, and, most importantly, for those in need.
 
 
Discover what your 25,000 future colleagues already know:
 
 
Why Syneos Health
 
<ul><li>We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
</li><li>We are committed to building an inclusive culture &ndash; where you can authentically be yourself. Central to this is our purpose &ndash; Driven to Deliver &ndash; which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone&rsquo;s life.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
</li></ul></div>Job Responsibilities
<ul><li>Open to hiring in North America and LATAM only with no sponsorship needs.
</li></ul><ul><li>Please submit CVs in English
</li></ul>Labeling Manager &ndash; Artwork Development and Source Text Review
Position Summary
The Labeling Artwork Reviewer is responsible for the review and approval of pharmaceutical labeling artwork to ensure compliance with regulatory requirements, internal standards, and market-specific guidelines. This role plays a critical part in ensuring the accuracy, clarity, and consistency of product package labeling across global markets.
Key Responsibilities
<ul><li>Review and approve labeling artwork (e.g., cartons, blisters, inserts, and labels) for regulatory compliance, readability, and alignment with approved labeling content.
</li><li>Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to ensure timely and accurate artwork development.
</li><li>Verify that artwork reflects approved applicable information from prescribing information, including dosage, administration, safety warnings, and product identification.
</li><li>Training and oversight of additional FSP resources for artwork management
</li><li>Ensure compliance with country-specific regulatory requirements, including FDA, EMA, and other global health authorities.
</li><li>Maintain documentation of artwork reviews, approvals, and version control in accordance with SOPs.
</li><li>Support the development and maintenance of country regional text lists (cRTL).
</li><li>Review of package component labeling (PCL) source text for compliance with Health Authority regulations for the respective countries.
</li><li>Participate in cross-functional meetings to support product launches, labeling updates, and change control processes.
</li><li>Support continuous improvement initiatives related to artwork review processes and labeling systems.
</li></ul>Required Knowledge/Skills
<ul><li>Strong understanding of regulatory labeling requirements (e.g., FDA, EMA, ICH) for printed components.
</li><li>Detail-oriented with excellent proofreading and quality control skills.
</li><li>Experience with annotation of artwork and working in artwork management systems.
</li><li>Familiarity with proofreading tools (e.g., TVT, Global Vision).
</li><li>Ability to work independently and collaboratively in a fast-paced environment.
</li><li>Strong communication and organizational skills.
</li></ul>Required Experience and Education Level
<ul><li>Bachelor&rsquo;s degree in Life Sciences, Pharmacy, Graphic Design, or a related field.
</li><li>2+ years of experience in pharmaceutical labeling, regulatory affairs, or artwork review.
</li></ul>Preferred Qualifications
<ul><li>Experience with global labeling and multilingual artwork.
</li><li>Knowledge of serialization, barcoding, and packaging regulations.
</li><li>Prior experience in a GMP-compliant environment.
</li></ul>At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate&rsquo;s qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health 
 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.</div>

Regulatory Labeling Manager – Artwork Development and Source Text Review(NA and LATAM Only)

<div>Project Financial Analyst I
<div>Syneos Health&reg; is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver &ndash; for one another, our customers, and, most importantly, for those in need.
 
 
Discover what your 25,000 future colleagues already know:
 
 
Why Syneos Health
 
<ul><li>We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
</li><li>We are committed to building an inclusive culture &ndash; where you can authentically be yourself. Central to this is our purpose &ndash; Driven to Deliver &ndash; which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone&rsquo;s life.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
</li></ul></div>Job Responsibilities
<div><div>Core Responsibilities
</div></div><div><ul><li>Supports Business Unit Controller in: Records revenue each month for Unit, Fee for Service and Fixed Price contracts.
</li><li>Loads project budgets into Oracle / Revenue Wizard and maintaining key member lists (project set up) and other project data in Oracle and associated systems and schedules.
</li><li>Drafts project level actual versus budget / forecast variance analysis monthly as well as monthly reports for distribution in analyzing monthly results.
</li><li>Drafts monthly forecasting of financial results ( backlog ).
</li><li>Meets established deadlines for Revenue and Backlog submittals.
</li><li>Timely preparation of project close out reconciliations.
</li><li>Reviews, with assistance, executed Work Orders and Change Orders for bonus or other anomalies.
</li><li>Works closely with Business Unit Controller to: Captures, assesses and consolidates results.
</li><li>Drafts key reports such as annual cost and expense budgets, cost rates, cost and expense forecasting, monthly utilization, headcount, revenue backlog analysis, and/or gross profit for assigned area.
</li><li>Updates predefined reports.
</li><li>Attends project meetings as applicable to support assigned areas. Attends project kick-off meetings to capture and process relevant data for set up of newly awarded projects onto financial systems and schedules. Attends monthly project review (MPRs) meetings to ensure understanding/concurrence of project status, potential issues and the accuracy of the forecast .
</li><li>Monitors the overall health of assigned projects including but not limited to revenues, gross profit, receivables, and unbilled amounts as well as project close outs and reconciliations .
</li></ul><div><div>Qualifications
</div></div><div><div><div><div><ul><li>4 Year BA/BS degree in Business, Accounting, Finance, or equivalent education and experience.
</li><li>Pharmaceutical or CRO experience preferred.
</li><li>Strong English proficiency. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) is essential.
</li><li>Proficiency with accounting software packages.
</li><li>Experience with Oracle Finance is preferred.
</li><li>Exceptional attention to detail, accuracy, organizational, interpersonal, and teamwork skills.
</li><li>Excellent financial, communication, and interpersonal skills as well as a high level of personal motivation to achieve.
</li><li>Demonstrated ability to work with confidential and sensitive data.
</li><li>Ability to perform several tasks simultaneously to meet deadlines is necessary.
</li></ul><div><div><div>Disclaimer
</div></div><div><div><div>Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
US ONLY
</div></div></div></div><div><div><div><div><div><div>Minimum of zero to two (0 - 2) years of related experience
</div></div></div></div><div><div>Physical Requirements : Position requires: ability to occasionally move about inside the office to access filing cabinets, office equipment, etc. and to move between office locations; ability to maintain a stationary position for prolonged periods of time; ability to occasionally manipulate (e.g., lift, carry, move) office items and packages of light to medium weights of 10-35 pounds; ability to constantly operate a computer and other office productivity equipment (e.g., scanner, phone, printer, copier); ability to perceive and assess written materials for prolonged periods of time; and ability to frequently communicate with colleagues on the phone, by email, and in-person.
Work Environment : This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. The noise level in the work environment is low. This is a largely sedentary role.
</div></div></div></div></div></div></div></div></div>At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$47,000.00 - $79,900.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate&rsquo;s qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health 
 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.</div>

Project Financial Analyst I

<div>Medical Assistant &ndash; Clinical Research (Bilingual English/Spanish) - Miami, FL
<div>Syneos Health&reg; is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver &ndash; for one another, our customers, and, most importantly, for those in need.
 
 
Discover what your 25,000 future colleagues already know:
 
 
Why Syneos Health
 
<ul><li>We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
</li><li>We are committed to building an inclusive culture &ndash; where you can authentically be yourself. Central to this is our purpose &ndash; Driven to Deliver &ndash; which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone&rsquo;s life.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
</li></ul></div>Job Responsibilities
I need compenstion support
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate&rsquo;s qualifications, skills, competencies, and proficiency for the role.
Get to know Syneos Health 
 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.</div>

Medical Assistant – Clinical Research (Bilingual English/Spanish) - Miami, FL

<div>Sr.CRA in Riyadh - Single Sponsor - CKD
Syneos Health&reg; is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you&rsquo;ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
<ul><li>We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
</li><li>We are committed to our Total Self culture &ndash; where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
</li><li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives &ndash; we&rsquo;re able to create a place where everyone feels like they belong.
</li></ul>Job Responsibilities
<ul><li>Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
</li><li>Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient&rsquo;s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
</li><li>Per the Clinical Monitoring/Site Management Plan (CMP/SMP):Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
 
Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines
 
Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements.
</li><li>May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
</li></ul>Qualifications:
<ul><li>Bachelor&rsquo;s degree or RN in a related field or equivalent combination of education, training and experience
</li><li>Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
</li><li>Must demonstrate good computer skills and be able to embrace new technologies
</li><li>Excellent communication, presentation and interpersonal skills. Moderate level of critical thinking skills expected.
</li><li>Ability to manage required travel of up to 75% on a regular basis
</li></ul>We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
Get to know Syneos Health 
 
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you&rsquo;ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
http://www.syneoshealth.com
Additional Information 
 
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.</div>

Sr.CRA in Riyadh - Single Sponsor - CKD

Join Syneos Health and explore 4   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Syneos Health

About Company

Regulatory Labeling Manager – Artwork Development and Source Text Review(NA and LATAM Only)

Project Financial Analyst I

Medical Assistant – Clinical Research (Bilingual English/Spanish) - Miami, FL

Sr.CRA in Riyadh - Single Sponsor - CKD