Syneos Health/ inVentiv Health Commercial LLC
Wichita, Kansas
Dir, Epidemiology RWE - Pharma/CRO Exp & PhD or Master Degree Must Have - Oncology/Immunology/InflammationSyneos Health 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'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health 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. We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. 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.Job ResponsibilitiesRequired Experience Lead development of study protocols, analysis plans, and study reports to answer research questions of priority to RWE Lead, design, and manage epidemiological, biomarker and/or data science projects Lead, plan, design, and conduct analyses for internal and external decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries) Lead the identification of fit-for-purpose data for the timely execution of the RWE strategy Constructed cohorts using RWD sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedures codes, and plan validation studies as needed Contribute to the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers Support the effective communication of study/analysis results to support internal and external decisions Coauthor abstracts and manuscripts for external dissemination of methodologic study results Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities Technical Expertiseo Observational research methods (both Primary and Secondary), deep knowledge of biostatistics and analysis methods, understanding of regulatory processes,o Ability to design studies independently, (ie ability to translate research questions to create study design) Subject Matter Expertiseo Provide subject matter expertise and conduct analyses for descriptive and comparative research using RWD (examples include claims, EHR, PRO/COA, registry data) for methodologic research questionsMinimum Qualifications PhD in Epidemiology, Biostatistics, Psychometrics, or related field with a minimum of four (4) years of relevant post-doctoral experience, preferably in pharmaceutical industry, biotechnology, or consulting environment. Master's degree in epidemiology, biostatistics, bioinformatics, or relevant scientific field, plus 7-9 years of experience in lieu of PhD may be acceptable. Deep understanding of observational research methods and experience to support the design and conduct of observational research, including protocol, statistical analysis plan, and study report development Extensive knowledge of secondary data sources and experience with secondary data analysis, including electronic medical record and/or medical claims databases A record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred Demonstrated ability to function with an increasing level of autonomy and to develop productive cross-functional collaborations in a matrix environment Ability to manage priorities and performance targets Experience in leading drug development project for 2+ years for therapeutic area of assignment preferredAt 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:$118,700.00 - $207,800.00The 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's qualifications, skills, competencies, and proficiency for the role.Get to know Syneos HealthOver 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'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.Additional InformationTasks, 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.
Dir, Epidemiology RWE - Pharma/CRO Exp & PhD or Master Degree Must Have - Oncology/Immunology/InflammationSyneos Health 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'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health 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. We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. 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.Job ResponsibilitiesRequired Experience Lead development of study protocols, analysis plans, and study reports to answer research questions of priority to RWE Lead, design, and manage epidemiological, biomarker and/or data science projects Lead, plan, design, and conduct analyses for internal and external decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries) Lead the identification of fit-for-purpose data for the timely execution of the RWE strategy Constructed cohorts using RWD sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedures codes, and plan validation studies as needed Contribute to the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers Support the effective communication of study/analysis results to support internal and external decisions Coauthor abstracts and manuscripts for external dissemination of methodologic study results Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities Technical Expertiseo Observational research methods (both Primary and Secondary), deep knowledge of biostatistics and analysis methods, understanding of regulatory processes,o Ability to design studies independently, (ie ability to translate research questions to create study design) Subject Matter Expertiseo Provide subject matter expertise and conduct analyses for descriptive and comparative research using RWD (examples include claims, EHR, PRO/COA, registry data) for methodologic research questionsMinimum Qualifications PhD in Epidemiology, Biostatistics, Psychometrics, or related field with a minimum of four (4) years of relevant post-doctoral experience, preferably in pharmaceutical industry, biotechnology, or consulting environment. Master's degree in epidemiology, biostatistics, bioinformatics, or relevant scientific field, plus 7-9 years of experience in lieu of PhD may be acceptable. Deep understanding of observational research methods and experience to support the design and conduct of observational research, including protocol, statistical analysis plan, and study report development Extensive knowledge of secondary data sources and experience with secondary data analysis, including electronic medical record and/or medical claims databases A record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred Demonstrated ability to function with an increasing level of autonomy and to develop productive cross-functional collaborations in a matrix environment Ability to manage priorities and performance targets Experience in leading drug development project for 2+ years for therapeutic area of assignment preferredAt 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:$118,700.00 - $207,800.00The 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's qualifications, skills, competencies, and proficiency for the role.Get to know Syneos HealthOver 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'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.Additional InformationTasks, 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.
Syneos Health/ inVentiv Health Commercial LLC
Anchorage, Alaska
Principal/Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA/Canada Remote BasedSyneos Health 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'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 EVERYWHEREWhy Syneos Health 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. We are committed to our Total Self culture - 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. 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 - we're able to create a place where everyone feels like they belong.Job Responsibilities Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed. Monitors timelines and budgets for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk. Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on quality review, compilation, and editorial standards. Provides training to members of the global medical writing team in aspects relative to their roles. Serves as project lead for deliverables of assigned complex and/or large medical writing projects, including, but not limited to, scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring all information is distributed to the editorial team and implemented within the deliverable. Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of editorial process. Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or various custom style guidelines as well as established medical writing internal checklists and best practices. Performs quality review of assigned documents to ensure accuracy. Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work. Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget. May compile medical writing deliverables.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:$62,000.00 - $108,600.00The 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's qualifications, skills, competencies, and proficiency for the role.Get to know Syneos HealthOver 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'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.Additional InformationTasks, 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.
Principal/Sr Medical Editor - Regulatory Documents - Copy Editing + QC - NA/Canada Remote BasedSyneos Health 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'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 EVERYWHEREWhy Syneos Health 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. We are committed to our Total Self culture - 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. 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 - we're able to create a place where everyone feels like they belong.Job Responsibilities Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed. Monitors timelines and budgets for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk. Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on quality review, compilation, and editorial standards. Provides training to members of the global medical writing team in aspects relative to their roles. Serves as project lead for deliverables of assigned complex and/or large medical writing projects, including, but not limited to, scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring all information is distributed to the editorial team and implemented within the deliverable. Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of editorial process. Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or various custom style guidelines as well as established medical writing internal checklists and best practices. Performs quality review of assigned documents to ensure accuracy. Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work. Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget. May compile medical writing deliverables.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:$62,000.00 - $108,600.00The 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's qualifications, skills, competencies, and proficiency for the role.Get to know Syneos HealthOver 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'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.Additional InformationTasks, 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.