Pharmaceutical Product Development
Payson, AZ 85541, USA
We have an exciting opportunity to join our best in class Global Regulatory Affairs team as a Regulatory Affairs Manager . This role is home-based and the preference for this position is a US West Coast candidate due to client time zones. This role provides technical leadership over a region, providing innovative solutions including regulatory affairs expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from pre-clinical through registration and product optimization. He/she provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services. Provides senior review and advice to prepare regulatory submissions and ensure high quality standards that meet client, local and regional requirements. Acts as subject matter expert in providing regulatory strategy advice and technical expertise to clients. Provides internal clients with up-to-date legislation and guidance as it becomes available. Ensures quality performance for managed projects. Manages project budgeting/forecasting functions. Identifies out of scope activities in a contract and liaises with other departments to follow through on contract modifications. Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments. Provides matrix leadership, training and guidance to junior team members. Participates in launch meetings, review meetings and project team meetings. #GD#PPDHPLI-NA1 Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 9 years). Knowledge, Skills and Abilities: Excellent English language (written and oral) communication skills as well as local language where applicable Excellent attention to detail and quality as well as excellent editorial / proofreading skills Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects Excellent negotiation skills Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to produce compliant deliverables Excellent understanding of global/regional/national country requirements / regulatory affairs procedures for clinical trial authorization, licensing, life cycle management; expert knowledge of ICH and other global regulatory guidelines Strong understanding of medical terminology, statistical concepts, and guidelines Excellent analytical, investigative and problem-solving skills Excellent understanding of budgeting and forecasting Management Role: No management responsibility PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel (30")
Feb 06, 2020
We have an exciting opportunity to join our best in class Global Regulatory Affairs team as a Regulatory Affairs Manager . This role is home-based and the preference for this position is a US West Coast candidate due to client time zones. This role provides technical leadership over a region, providing innovative solutions including regulatory affairs expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from pre-clinical through registration and product optimization. He/she provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services. Provides senior review and advice to prepare regulatory submissions and ensure high quality standards that meet client, local and regional requirements. Acts as subject matter expert in providing regulatory strategy advice and technical expertise to clients. Provides internal clients with up-to-date legislation and guidance as it becomes available. Ensures quality performance for managed projects. Manages project budgeting/forecasting functions. Identifies out of scope activities in a contract and liaises with other departments to follow through on contract modifications. Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments. Provides matrix leadership, training and guidance to junior team members. Participates in launch meetings, review meetings and project team meetings. #GD#PPDHPLI-NA1 Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 9 years). Knowledge, Skills and Abilities: Excellent English language (written and oral) communication skills as well as local language where applicable Excellent attention to detail and quality as well as excellent editorial / proofreading skills Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects Excellent negotiation skills Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to produce compliant deliverables Excellent understanding of global/regional/national country requirements / regulatory affairs procedures for clinical trial authorization, licensing, life cycle management; expert knowledge of ICH and other global regulatory guidelines Strong understanding of medical terminology, statistical concepts, and guidelines Excellent analytical, investigative and problem-solving skills Excellent understanding of budgeting and forecasting Management Role: No management responsibility PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel (30")
$500 - $1500/week Work From Home/Data Entry Positions Open Location: Work from home; Work online; Part-time or Full Time During these trying economic times and high unemployment rates, hundreds of thousands of people just like you around the country and even in your area are getting positions and getting paid working from home. If you have access to the internet and a computer, then you qualify for this position: High income potential for the right person. You set your own hours and work wherever you have an internet connection. Keep your current job you have if you want or use this to supplement your income while you look for another job Be up and running in less than 24 hours Work at your own pace. Some people are making as much as $5000 per week and more. There are no ceilings. Start ASAP
Feb 06, 2020
$500 - $1500/week Work From Home/Data Entry Positions Open Location: Work from home; Work online; Part-time or Full Time During these trying economic times and high unemployment rates, hundreds of thousands of people just like you around the country and even in your area are getting positions and getting paid working from home. If you have access to the internet and a computer, then you qualify for this position: High income potential for the right person. You set your own hours and work wherever you have an internet connection. Keep your current job you have if you want or use this to supplement your income while you look for another job Be up and running in less than 24 hours Work at your own pace. Some people are making as much as $5000 per week and more. There are no ceilings. Start ASAP
$500 - $1500/week Work From Home/Data Entry Positions Open Location: Work from home; Work online; Part-time or Full Time During these trying economic times and high unemployment rates, hundreds of thousands of people just like you around the country and even in your area are getting positions and getting paid working from home. If you have access to the internet and a computer, then you qualify for this position: High income potential for the right person. You set your own hours and work wherever you have an internet connection. Keep your current job you have if you want or use this to supplement your income while you look for another job Be up and running in less than 24 hours Work at your own pace. Some people are making as much as $5000 per week and more. There are no ceilings. Start ASAP
Feb 06, 2020
$500 - $1500/week Work From Home/Data Entry Positions Open Location: Work from home; Work online; Part-time or Full Time During these trying economic times and high unemployment rates, hundreds of thousands of people just like you around the country and even in your area are getting positions and getting paid working from home. If you have access to the internet and a computer, then you qualify for this position: High income potential for the right person. You set your own hours and work wherever you have an internet connection. Keep your current job you have if you want or use this to supplement your income while you look for another job Be up and running in less than 24 hours Work at your own pace. Some people are making as much as $5000 per week and more. There are no ceilings. Start ASAP
Pharmaceutical Product Development
Payson, AZ 85541, USA
We have an exciting opportunity to join our best in class Global Regulatory Affairs team as a Regulatory Affairs Manager . This role is home-based and the preference for this position is a US West Coast candidate due to client time zones. This role provides technical leadership over a region, providing innovative solutions including regulatory affairs expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from pre-clinical through registration and product optimization. He/she provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services. Provides senior review and advice to prepare regulatory submissions and ensure high quality standards that meet client, local and regional requirements. Acts as subject matter expert in providing regulatory strategy advice and technical expertise to clients. Provides internal clients with up-to-date legislation and guidance as it becomes available. Ensures quality performance for managed projects. Manages project budgeting/forecasting functions. Identifies out of scope activities in a contract and liaises with other departments to follow through on contract modifications. Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments. Provides matrix leadership, training and guidance to junior team members. Participates in launch meetings, review meetings and project team meetings. #GD#PPDHPLI-NA1 Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 9 years). Knowledge, Skills and Abilities: Excellent English language (written and oral) communication skills as well as local language where applicable Excellent attention to detail and quality as well as excellent editorial / proofreading skills Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects Excellent negotiation skills Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to produce compliant deliverables Excellent understanding of global/regional/national country requirements / regulatory affairs procedures for clinical trial authorization, licensing, life cycle management; expert knowledge of ICH and other global regulatory guidelines Strong understanding of medical terminology, statistical concepts, and guidelines Excellent analytical, investigative and problem-solving skills Excellent understanding of budgeting and forecasting Management Role: No management responsibility PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel (30")
Feb 05, 2020
We have an exciting opportunity to join our best in class Global Regulatory Affairs team as a Regulatory Affairs Manager . This role is home-based and the preference for this position is a US West Coast candidate due to client time zones. This role provides technical leadership over a region, providing innovative solutions including regulatory affairs expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from pre-clinical through registration and product optimization. He/she provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services. Provides senior review and advice to prepare regulatory submissions and ensure high quality standards that meet client, local and regional requirements. Acts as subject matter expert in providing regulatory strategy advice and technical expertise to clients. Provides internal clients with up-to-date legislation and guidance as it becomes available. Ensures quality performance for managed projects. Manages project budgeting/forecasting functions. Identifies out of scope activities in a contract and liaises with other departments to follow through on contract modifications. Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments. Provides matrix leadership, training and guidance to junior team members. Participates in launch meetings, review meetings and project team meetings. #GD#PPDHPLI-NA1 Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 9 years). Knowledge, Skills and Abilities: Excellent English language (written and oral) communication skills as well as local language where applicable Excellent attention to detail and quality as well as excellent editorial / proofreading skills Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects Excellent negotiation skills Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to produce compliant deliverables Excellent understanding of global/regional/national country requirements / regulatory affairs procedures for clinical trial authorization, licensing, life cycle management; expert knowledge of ICH and other global regulatory guidelines Strong understanding of medical terminology, statistical concepts, and guidelines Excellent analytical, investigative and problem-solving skills Excellent understanding of budgeting and forecasting Management Role: No management responsibility PPD values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel (30")
ICF seeks an experienced Early Childhood (EC) Specialist to support Head Start and Early Head Start programs to ensure high quality Head Start and Early Head Start services in accordance with federal regulations. The Early Childhood Specialist will provide training and technical assistance (TTA) to programs to support progress toward established school readiness goals, focusing on the use of child and program data to make decisions about approaches to working with teachers, home visitors, and parents in quality practices. The Specialist will provide professional-level expertise by engaging programs in dialogue and learning of best practices for children from birth to five and encourage a culture of learning that promotes school readiness. This position is home-based in one of the Region VIII states and will involve extensive travel to programs within the 6 states identified as the Federal Region VIII ( Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming ) Basic Qualifications: Bachelor's Degree in Early Childhood Education or Child Development (18 ECE credits are required, transcripts will be requested), and ten years of professional experience. 5+ years of demonstrated experience in the field of early childhood education. 5+ years of experience offering training and technical assistance within early care and education. Ability to maintain up to date knowledge of current child development practices and research based early childhood quality methods and approaches. Understanding of developmentally appropriate practice in early childhood education and the ability to support its use in school readiness goals. Must have valid driver's license and successfully pass a Motor Vehicle Records (MVR) check. Preferred Experience/Skills: Knowledge of Head Start performance standards and all applicable federal, state and local laws, rules and regulations. Experience working within a Head Start Program. Professional Skills: Experience with Microsoft Office (Word, Excel and PowerPoint) required. Excellent verbal and written communication skills required. Strong analytical, problem-solving and decision-making capabilities. Team player with the ability to work in a fast-paced environment. Ability to work with all levels of internal staff, as well as outside clients and vendors. Working at ICF Working at ICF means applying a passion for meaningful work with intellectual rigor to help solve the leading issues of our day. Smart, compassionate, innovative, committed, ICF employees tackle unprecedented challenges to benefit people, businesses, and governments around the globe. We believe in collaboration, mutual respect, open communication, and opportunity for growth. If you're seeking to make a difference in the world, visit /careers to find your next career. ICF"together for tomorrow. ICF is an equal opportunity employer that values diversity at all levels. (EOE - Minorities/Females/ Protected Veterans Status/Disability Status/Sexual Orientation/Gender Identity) Reasonable Accommodations are available for disabled veterans and applicants with disabilities in all phases of the application and employment process. To request an accommodation please email icfcareercenter@and we will be happy to assist. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations. Read more about non-discrimination: EEO is the law and Pay Transparency Statement. A consulting services company of over 5,000 experts across 67 countries, but not your typical consultants Associated topics: associate kindergarten teacher, baby, child care, early, early education, kindergarten, nursery education, pre kindergarten, preschool assistant teacher, preschool teacher
Feb 05, 2020
ICF seeks an experienced Early Childhood (EC) Specialist to support Head Start and Early Head Start programs to ensure high quality Head Start and Early Head Start services in accordance with federal regulations. The Early Childhood Specialist will provide training and technical assistance (TTA) to programs to support progress toward established school readiness goals, focusing on the use of child and program data to make decisions about approaches to working with teachers, home visitors, and parents in quality practices. The Specialist will provide professional-level expertise by engaging programs in dialogue and learning of best practices for children from birth to five and encourage a culture of learning that promotes school readiness. This position is home-based in one of the Region VIII states and will involve extensive travel to programs within the 6 states identified as the Federal Region VIII ( Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming ) Basic Qualifications: Bachelor's Degree in Early Childhood Education or Child Development (18 ECE credits are required, transcripts will be requested), and ten years of professional experience. 5+ years of demonstrated experience in the field of early childhood education. 5+ years of experience offering training and technical assistance within early care and education. Ability to maintain up to date knowledge of current child development practices and research based early childhood quality methods and approaches. Understanding of developmentally appropriate practice in early childhood education and the ability to support its use in school readiness goals. Must have valid driver's license and successfully pass a Motor Vehicle Records (MVR) check. Preferred Experience/Skills: Knowledge of Head Start performance standards and all applicable federal, state and local laws, rules and regulations. Experience working within a Head Start Program. Professional Skills: Experience with Microsoft Office (Word, Excel and PowerPoint) required. Excellent verbal and written communication skills required. Strong analytical, problem-solving and decision-making capabilities. Team player with the ability to work in a fast-paced environment. Ability to work with all levels of internal staff, as well as outside clients and vendors. Working at ICF Working at ICF means applying a passion for meaningful work with intellectual rigor to help solve the leading issues of our day. Smart, compassionate, innovative, committed, ICF employees tackle unprecedented challenges to benefit people, businesses, and governments around the globe. We believe in collaboration, mutual respect, open communication, and opportunity for growth. If you're seeking to make a difference in the world, visit /careers to find your next career. ICF"together for tomorrow. ICF is an equal opportunity employer that values diversity at all levels. (EOE - Minorities/Females/ Protected Veterans Status/Disability Status/Sexual Orientation/Gender Identity) Reasonable Accommodations are available for disabled veterans and applicants with disabilities in all phases of the application and employment process. To request an accommodation please email icfcareercenter@and we will be happy to assist. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations. Read more about non-discrimination: EEO is the law and Pay Transparency Statement. A consulting services company of over 5,000 experts across 67 countries, but not your typical consultants Associated topics: associate kindergarten teacher, baby, child care, early, early education, kindergarten, nursery education, pre kindergarten, preschool assistant teacher, preschool teacher
$500 - $1500/week Work From Home/Data Entry Positions Open Location: Work from home; Work online; Part-time or Full Time During these trying economic times and high unemployment rates, hundreds of thousands of people just like you around the country and even in your area are getting positions and getting paid working from home. If you have access to the internet and a computer, then you qualify for this position: High income potential for the right person. You set your own hours and work wherever you have an internet connection. Keep your current job you have if you want or use this to supplement your income while you look for another job Be up and running in less than 24 hours Work at your own pace. Some people are making as much as $5000 per week and more. There are no ceilings. Start ASAP
Feb 05, 2020
$500 - $1500/week Work From Home/Data Entry Positions Open Location: Work from home; Work online; Part-time or Full Time During these trying economic times and high unemployment rates, hundreds of thousands of people just like you around the country and even in your area are getting positions and getting paid working from home. If you have access to the internet and a computer, then you qualify for this position: High income potential for the right person. You set your own hours and work wherever you have an internet connection. Keep your current job you have if you want or use this to supplement your income while you look for another job Be up and running in less than 24 hours Work at your own pace. Some people are making as much as $5000 per week and more. There are no ceilings. Start ASAP
$500 - $1500/week Work From Home/Data Entry Positions Open Location: Work from home; Work online; Part-time or Full Time During these trying economic times and high unemployment rates, hundreds of thousands of people just like you around the country and even in your area are getting positions and getting paid working from home. If you have access to the internet and a computer, then you qualify for this position: High income potential for the right person. You set your own hours and work wherever you have an internet connection. Keep your current job you have if you want or use this to supplement your income while you look for another job Be up and running in less than 24 hours Work at your own pace. Some people are making as much as $5000 per week and more. There are no ceilings. Start ASAP
Feb 05, 2020
$500 - $1500/week Work From Home/Data Entry Positions Open Location: Work from home; Work online; Part-time or Full Time During these trying economic times and high unemployment rates, hundreds of thousands of people just like you around the country and even in your area are getting positions and getting paid working from home. If you have access to the internet and a computer, then you qualify for this position: High income potential for the right person. You set your own hours and work wherever you have an internet connection. Keep your current job you have if you want or use this to supplement your income while you look for another job Be up and running in less than 24 hours Work at your own pace. Some people are making as much as $5000 per week and more. There are no ceilings. Start ASAP
We are looking for people nationwide interested in working from home that are dependable and looking to make $1,000-$1,500 weekly. You work on your own schedule right from your computer. Need to be able to take surveys daily. Get paid to share your opinions for FREE! You must provide a valid e-mail address in order to move forward.
Feb 05, 2020
We are looking for people nationwide interested in working from home that are dependable and looking to make $1,000-$1,500 weekly. You work on your own schedule right from your computer. Need to be able to take surveys daily. Get paid to share your opinions for FREE! You must provide a valid e-mail address in order to move forward.
We are looking for people nationwide interested in working from home that are dependable and looking to make $1,000-$1,500 weekly. You work on your own schedule right from your computer. Need to be able to take surveys daily. Get paid to share your opinions for FREE! You must provide a valid e-mail address in order to move forward.
Feb 05, 2020
We are looking for people nationwide interested in working from home that are dependable and looking to make $1,000-$1,500 weekly. You work on your own schedule right from your computer. Need to be able to take surveys daily. Get paid to share your opinions for FREE! You must provide a valid e-mail address in order to move forward.