Qureos Mentor

Syneos Health

<div>Description
Tech Business Analyst II
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.
Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life&reg;.
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>Identifies and documents emerging business requirements; Questions business partner and</li></ul>
knowledge worker preferences to identify unique value drivers 
<ul><li>Capture business requirements, functional and nonfunctional requirements. Create and maintain technical documentation, including specifications, user guides and reports</li><li>Prioritize competing business demands, elicit high-level business requirements, and assess the risks of various solution options to different options.</li><li>Communicate between business units, technology teams, and support teams, aligning the needs of business units with the capabilities delivered by information technology and serves as a &ldquo;translator&rdquo; between those groups.</li><li>Manages requirements to meet performance expectations</li><li>Facilitate communication between technical teams and non-technical business stakeholders to ensure alignment and clarity.</li><li>Present ideas in a concise, focused manner. Surface potential impacts of the solution on all stakeholders. Articulates the role of technology in terms easily understood by business constituencies.</li></ul> 
Additional Qualifications<ul><li>Bachelor&rsquo;s degree in - Computer science, Engineering or related field.</li><li>Self-starter, proactive, strong-business acumen, excellent follow-through.</li><li>Primary Business Analyst on several medium to large complexity projects. (preferred)</li><li>Demonstrated ability to define business requirements and measure / communicate proposed project benefits (preferred)</li><li>Demonstrated knowledge of both traditional Agile methodologies.</li><li>Experience in converting business requirements and functional requirements to use cases, epics, and user stories with acceptance criteria. (preferred)</li><li>Demonstrated ability to engage both developers and business partners to achieve target outcomes</li><li>Excellent written and verbal communications; Solid written and oral presentation skills</li><li>Ability to keep control of the room in a way that is not off-putting; Natural ability to redirect and refocus conversations with people at different levels when needed</li><li>Ensures and advises business stakeholders by actively initiating and influencing what is needed versus how their needs will be achieved; Ability to drive change</li><li>Analytic Ability: ability to work with data to identify patterns; Uses judgment to form conclusions that may challenge conventional wisdom, and focuses on the crux of issues to identify high leverage intervention points and strategies</li><li>Exhibits high levels of engagement with stakeholders at all levels and understanding high depths of business context</li><li>Proficient with MS Office applications (e.g. Visio, Word, Excel, Power Point, etc.)</li></ul>
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.
Summary
The Tech Business Analyst II is responsible for leading the analysis of complex business problems and guiding the design and implementation of advanced business solutions. This role collaborates withstakeholders, business partners, and vendors to implement and support solutions to optimize performance, drive savings, and enhance the company&rsquo;s competitive edge.</div>

Tech Business Analyst II

<div>Description
Solutions Architect - Development &amp; Process Improvement
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.
Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life&reg;.
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
Job Summary 
The Technology &amp; Data Solutions (TDS) business unit is the Syneos Health accelerator for life sciences innovation. TDS houses our advanced technology acquisitions, homegrown products &amp; applications, actively participates in new M&amp;A and partnership activities, delivers critical insights as part of our integrated strategy for customers and drives enterprise-wide adoption and change management for innovative tech &amp; data solutions. Our work supports getting meaningful new medicines to patients faster, with greater positive impact. The Solutions Architect supports our business goals by translating business rules and stakeholder requirements into work plans and implementation strategies to support the needs of our customers. 
Core Responsibilities<div><ul><li> 
Work independently to solve open-ended questions.</li><li>Gather project requirements and specifications from clients and internal stakeholders (technical and non-technical) during the project development lifecycle.</li><li>Translate business rules and stakeholder requirements into project specifications that leverage internal and external systems.</li><li>Design data ingestion and transformation systems and processes.</li><li>Support development team and process by developing production schedules and test plans, generating documentation, and assembling presentation material that define project guidelines and milestones.</li><li>Engage directly with clients to communicate project updates (via in-person demonstrations, virtual calls/emails) throughout the production lifecycle; and moderate the change-management process.</li><li>Coordinate internal (data engineers, data scientists, dashboarding teams) and external resources (e.g., data vendors) to ensure timely production cycle and client delivery.</li><li>Independently prototype analytic tools and resources for quick-turn proof-of-concept scenarios, troubleshooting, and project development.</li><li>Manage multiple production requirements, workstreams, and timelines, while ensuring that project outcomes match or exceed client expectations.</li><li>Design and develop data models that support our enterprise client-facing healthcare analytic product line (e.g., dashboards, apps, widgets, automated reporting).</li></ul></div><div> 
Qualifications 
 
<ul><li>Degree (BS/BA required, MS/MA preferred) in Information Systems or Management, Statistics, Software Engineering, Computer Science, Data Science, Engineering, or related field.</li><li>Experience utilizing and leveraging modern data and cloud technologies, like Snowflake, SQL Server, Tableau, Power BI, and Azure.</li><li>Experience in architecting, designing, and implementing data-centric and/or software solutions.</li><li>Experience creating custom and templated data models for Operational, Performance, and/or BI dashboards/reports.</li><li>Strong background in statistics, data modeling, and machine learning concepts.</li><li>Experience collaborating with both onshore and offshore product dev teams is preferred.</li><li>Strong verbal and written communication skills.</li><li>Experience with healthcare marketing analytics, healthcare data (Rx, Medical claims) and common medical coding sets (ICD, HCPCs, NPIs) is a plus.</li></ul></div>
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>

Solutions Architect - Development & Process Improvement

<div>Description
Site Activation Specialist II/ Sr. Can be Home- based or Hybrid
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>
Roles within the Site Start-Up/Site ID job family are responsible for managing and executing the site identification process in accordance with regulations, SOPs, and project requirements. This includes completing and negotiating site confidentiality agreements (CDAs) and site information forms (SIFs) with sites, maintaining, reviewing, and reporting on site performance metrics, serving as the primary point of contact for investigative sites, and tracking the completion of site identification for sites.
Impact and Contribution 
Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.</li><li>
Responsible for the quality deliverables at the country level; follows project requirements and aapplicable country rules with moderate oversight from the SSU Country Manager. Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached: investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified.</li><li>
Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.</li><li>
Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.</li><li>
Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).</li><li>
Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.</li><li>
Responsible for the Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SAM. May serve as a point of contact for the PM/SAM (or designee) during start-up on allocated projects. Complies and/or reviews essential document packages for site activation and may also be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with moderate oversight from the SSU Country Manager.</li><li>
May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversee site activation end to end process at country/ site level.</li><li>
Country Start-Up Advisor - Acts as Subject Matter Advisor for in-country performance within the Site Start-Up. Supports country-level intelligence on start-up (SU) and clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the local SU and CTR team, is maintained on the central repository, e.g., Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/export license applications where these are obtained with RA applications. In absence of legal advisor or dedicated subject matter may provide support for data protection at the country and provide guidance at a country level on data protection statements that need to be included on those documents which the Sponsor has contracted to the Company start-up group to adapt to local requirements. This may include the Principal Investigator/Informed Consent and the Confidential Disclosure Agreement/contract template. Provides input in local SOPs and WI. Supports the creation of internal training materials on local legislation requirements. Provides input to the team to assist with EC or CA issue resolution at the country level. 
Local Site ID and Feasibility Support &ndash; Provides support with site selection lead and PM/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.</li><li>
May be asked to perform: Local Investigator Contract and Budget Negotiator &ndash; Provides support to SAM to agree on country template contract and budget. Produces site-specific contracts from country template. Provide support in submissions for proposed contract and budget for site. Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SAM with Sponsor until resolution of issues and contract execution. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
Qualifications</li><li>
Bachelor&rsquo;s Degree,</li><li>
Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.</li><li>
Ability to understand clinical protocols and associated study specifications.</li><li>
Detailed understanding of clinical trial start-up processes.</li><li>
Ability to manage external vendors to contract effectively.</li><li>
Strong organizational skills with ability to handle multiple tasks effectively.</li><li>
Strong written and verbal communication and interpersonal skills.</li><li>
Ability to manage multiple project budgets with increased complexity and value.</li><li>
Quality-driven in all managed activities.</li><li>
Good negotiating skills.</li><li>
Good problem-solving skills.</li><li>
Demonstrated ability to work independently as well as part of a team.</li></ul>
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.
Summary
Roles within the Site Start-Up/Site ID job family are responsible for managing and executing the site identification process in accordance with regulations, SOPs, and project requirements. This includes completing and negotiating site confidentiality agreements (CDAs) and site information forms (SIFs) with sites, maintaining, reviewing, and reporting on site performance metrics, serving as the primary point of contact for investigative sites, and tracking the completion of site identification for sites.Impact and ContributionIndividual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.</div>

Site Activation Specialist II/ Sr. Can be Home- based or Hybrid

<div>Description
Senior Data Scientist - Azure &amp; Causal Analysis
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.
Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life&reg;.
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
Job Summary 
The Technology &amp; Data Solutions (TDS) business unit is the Syneos Health accelerator for life sciences innovation. TDS houses our advanced technology acquisitions, homegrown products &amp; applications, actively participates in new M&amp;A and partnership activities, delivers critical insights as part of our integrated strategy for customers and drives enterprise-wide adoption and change management for innovative tech &amp; data solutions. Our work supports getting meaningful new medicines to patients faster, with greater positive impact. The Senior Data Scientist supports our business goals by providing timely delivery of high-quality data science solutions and innovative products. 
Core Responsibilities<div><ul><li> 
Design, develop, and program methods, processes, and systems to consolidate and analyze unstructured, diverse &ldquo;big data&rdquo; sources to generate actionable insights and solutions for client services and product enhancement.</li><li>Interact with product and service teams to identify questions and issues for data analysis and experiments.</li><li>Create, document, and manage templates and standard operating procedures for algorithms, code repositories, rules, manuals, and other assets.</li><li>Develop and code software programs, algorithms, and automated processes to cleanse, integrate and evaluate large datasets from multiple disparate sources.</li><li>Assist team in identifying meaningful insights from large data and metadata sources, interpreting and communicating insights and findings from analysis and experiments to product, service, and business managers.</li><li>Have broad expertise or innovative knowledge, use skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.</li><li>Work on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.</li><li>Manage configuration, curation, and cataloging of internal and external tech and data resources and &lsquo;always-on&rsquo; data vendors to ensure timely product delivery and innovation.</li><li>Mentor and coach junior team members across the business.</li></ul></div> 
Qualifications<div><ul><li> 
Masters in a STEM field required, PhD preferred.</li><li>Proficiency with a programming language (e.g., Python, R) and a database language (e.g., SQL).</li><li>Must be organized, detail oriented and work effectively in a fast-paced environment.</li><li>Strong data analysis and data modelling skills, good knowledge of statistics.</li><li>Demonstrated ability to independently execute projects.</li><li>Able to influence and unify the direct team and peers, as well as interact effectively as a strategic partner with senior management.</li><li>Detailed understanding of how data science models are developed.</li><li>Independent problem-solving and grit. Willingness to own one&rsquo;s work, and confidence to push best practices. Strong attention to detail.</li><li>Experience with healthcare or B2B/B2C marketing.</li></ul></div>
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.
Summary
The Technology Solutions business unit is the Syneos Health accelerator for life sciences technology and innovation. Our work supports getting meaningful new medicines to patients faster with greater positive impact. Technology Solutions homegrown products and applications, commercial off-the-shelf, and software-as-a-service products ensure all employees work in a secure environment with clean data and deliver insights as part of our integrated strategy for customers.The Sr Data Scientist will work on data science initiatives and guide teams through the development of models and analytical frameworks. This role is responsible for collecting, storing, and interpreting data in a meaningful and clear way for our customers.</div>

Senior Data Scientist - Azure & Causal Analysis

<div>
 
 Description
 
 
 
 Senior Consultant Regulatory Intelligence (Portugal or Serbia based)
 
 
 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
 
 
 
 JOB RESPONSIBILITIES
 
 
 <ul>
 <li>
 Gather new regulatory information through routine surveillance of agreed regulatory sources.
 </li>
 <li>
 Reviews surveillance alerts and queries and determines actions to be taken.
 </li>
 <li>
 Support ad-hoc research requests from the business and gather regulatory information for potentially new topics.
 </li>
 <li>
 Manage Regulatory Intelligence Network list of functional SMEs.
 </li>
 <li>
 Interacts with external and internal experts to collect country and region-specific regulatory intelligence.
 </li>
 <li>
 Conducts searches within commercial Regulatory Intelligence databases to identify regulations and guidelines relevant for clinical regulatory intelligence.
 </li>
 <li>
 Keeps abreast of regulations, trends, developments, and advances in the global regulatory environment.
 </li>
 <li>
 Identifies and responds appropriately to issues and problems, providing innovative and effective solutions.
 </li>
 <li>
 Recommends and implements enhancements of Syneos Health Regulatory Intelligence processes to maintain the Regulatory Intelligence System
 </li>
 <li>
 Performs other work-related duties as assigned.
 
 
 </li>
 </ul>
 
 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.
 
 
 
 Summary
 
 
 
 The Regulatory Intelligence Department at Syneos Health impact decision-making at the highest levels. The team translate and refine Syneos Health regulatory intelligence from internal and external sources and combine knowledge from therapy areas and functions to deliver proactive advice outlining risks and new opportunities to the regulatory strategy and operations. The Senior Consultant, Regulatory Intelligence is an internal facing role that supports keeping the Syneos Health Regulatory Intelligence System current and accurate via regular surveillance and interaction with subject matter experts.
</div>

Senior Consultant Regulatory Intelligence (Portugal or Serbia based)

<div>Description
Senior Consultant Regulatory Intelligence (Portugal or Serbia based)
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<h3 class="jobSectionHeader">
JOB RESPONSIBILITIES</h3><ul><li>
Gather new regulatory information through routine surveillance of agreed regulatory sources.</li><li>
Reviews surveillance alerts and queries and determines actions to be taken.</li><li>
Support ad-hoc research requests from the business and gather regulatory information for potentially new topics.</li><li>
Manage Regulatory Intelligence Network list of functional SMEs.</li><li>
Interacts with external and internal experts to collect country and region-specific regulatory intelligence.</li><li>
Conducts searches within commercial Regulatory Intelligence databases to identify regulations and guidelines relevant for clinical regulatory intelligence.</li><li>
Keeps abreast of regulations, trends, developments, and advances in the global regulatory environment.</li><li>
Identifies and responds appropriately to issues and problems, providing innovative and effective solutions.</li><li>
Recommends and implements enhancements of Syneos Health Regulatory Intelligence processes to maintain the Regulatory Intelligence System</li><li>
Performs other work-related duties as assigned.</li></ul>
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.
Summary
The Regulatory Intelligence Department at Syneos Health impact decision-making at the highest levels. The team translate and refine Syneos Health regulatory intelligence from internal and external sources and combine knowledge from therapy areas and functions to deliver proactive advice outlining risks and new opportunities to the regulatory strategy and operations.The Senior Consultant, Regulatory Intelligence is an internal facing role that supports keeping the Syneos Health Regulatory Intelligence System current and accurate via regular surveillance and interaction with subject matter experts.</div>

<div>Description
Principal Stat programmer(SDTM, ADAM, TLF)
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>
Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements.</li><li>
Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. &middot; Keeps project team members informed of programming progress and issues requiring their attention.</li><li>
Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).</li><li>
Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness.</li><li>
Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.</li><li>
Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.</li><li>
Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus.</li><li>
Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.</li><li>
Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions.</li><li>
Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables.</li><li>
Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities.</li><li>
Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor.</li><li>
Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process.</li><li>
Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions.</li><li>
Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures.</li><li>
Contributes technical expertise to the development of programming tools and macros for standardization and efficiency.</li><li>
When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards</li><li>
When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML)</li><li>
When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards.</li><li>
Transfers deliverables.</li><li>
Performs other work-related duties as assigned.</li><li>
Minimal travel may be required</li></ul>
Qualifications:<ul><li>
Require 8+ years of experience in Clinical SAS Programming.</li><li>
Muat have strong expertise of Base SAS/SAS Macros, SDTM, ADAM &amp; TLF programming, specs creation.</li><li>
Must have hands on experience of Safety &amp; efficacy data,</li><li>
Good to have experience of Oncology therapeutic areas.</li><li>
Must have ISS/ ISE experience, R programming</li><li>
Excellent written and verbal communication skills.</li><li>
Ability to read, write, speak and understand English.</li><li>
We are preferring Immediate joiners</li></ul>
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.
Summary
Roles within the Statistical Programming job family are responsible for developing programs and providing statistical programming support for statisticians or for client or business use to address needs for sourcing, organizing (creating statistical tables, listings, and graphs), and interpreting complex data sets utilizing codes and programs. This includes developing codes that create analysis datasets, tables, and figures, evaluating programming processes, and suggesting revisions geared toward increasing productivity.Impact and ContributionIndividual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Leading expert individual contributor who is viewed as a valuable resource by peers. Works to achieve organizational, functional, and/or business targets with measurable impact on department results. Manages or contributes to projects, programs, or processes that span multiple related areas. Comprehensive knowledge and skills in a professional discipline, understanding the impact of work on related areas.</div>

Principal Stat programmer(SDTM, ADAM, TLF)

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Principal Stat programmer(SDTM, ADAM, TLF)