Providing critical support for Penumbra’s clinical trials, you will prepare SAS programs to enable the preparation and statistical analysis of clinical data. You will coordinate the statistical programming activities for multiple clinical projects and partner with other programmers, statisticians, and clinical data managers in the collection, analysis, and reporting of clinical data for trials. This is a contract position planned to last a duration of 6-12 months.
The job
Independently lead and perform all statistical programming activities for your projects.
Creating the clinical trial data sets and programs for regulatory submissions and ensuring their accuracy.
Help develop the SAPs for our clinical studies and interpret statistical analysis plans to develop analysis and data set specifications.
Determine scope of peer reviews and ensure that the accuracy of the SAS programs by reviewing the output, code, and log files.
Maintain expertise in the use of SAS Macros, formulate proposals and create new SAS macros while maintaining existing Macros.
Identifying opportunities for productivity improvements and figuring out implementation plans.
Serve as statistical programming SME, providing specific expertise on timeline development, identification of statistical programming deliverables and resource requirements helping create, review, and maintain project timelines and monitor progress of statistical programming activities.
Interact with data management, biostatistics, clinical affairs, medical affairs, regulatory affairs, quality assurance staff, and external data analysis vendors.
Mentor other statistical programmers and monitor their performance.
Provide input into SOP reviews and write effective SOP's on statistical programming.
What you bring
The desire to take on complex challenges and work with a great team.
Bachelor’s or Masters degree in Statistics, Computer Science, or a similar quantitative field with a minimum of 7-12 years or relevant experience of combined educational and job experience.
Competence in SAS programming and Macro development.
Experience with clinical trials, including familiarity with expectations of regulatory agencies, FDA preferred.
Ability to interpret statistical analysis plans to develop analysis data set specifications.
SAS Certified Base and/or Advance Programmer experience preferred.
Excellent oral, written, and interpersonal communication skills.
Attention to detail and the ability to handle multiple tasks.
What we offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be at the forefront of technology that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Sep 12, 2019
Providing critical support for Penumbra’s clinical trials, you will prepare SAS programs to enable the preparation and statistical analysis of clinical data. You will coordinate the statistical programming activities for multiple clinical projects and partner with other programmers, statisticians, and clinical data managers in the collection, analysis, and reporting of clinical data for trials. This is a contract position planned to last a duration of 6-12 months.
The job
Independently lead and perform all statistical programming activities for your projects.
Creating the clinical trial data sets and programs for regulatory submissions and ensuring their accuracy.
Help develop the SAPs for our clinical studies and interpret statistical analysis plans to develop analysis and data set specifications.
Determine scope of peer reviews and ensure that the accuracy of the SAS programs by reviewing the output, code, and log files.
Maintain expertise in the use of SAS Macros, formulate proposals and create new SAS macros while maintaining existing Macros.
Identifying opportunities for productivity improvements and figuring out implementation plans.
Serve as statistical programming SME, providing specific expertise on timeline development, identification of statistical programming deliverables and resource requirements helping create, review, and maintain project timelines and monitor progress of statistical programming activities.
Interact with data management, biostatistics, clinical affairs, medical affairs, regulatory affairs, quality assurance staff, and external data analysis vendors.
Mentor other statistical programmers and monitor their performance.
Provide input into SOP reviews and write effective SOP's on statistical programming.
What you bring
The desire to take on complex challenges and work with a great team.
Bachelor’s or Masters degree in Statistics, Computer Science, or a similar quantitative field with a minimum of 7-12 years or relevant experience of combined educational and job experience.
Competence in SAS programming and Macro development.
Experience with clinical trials, including familiarity with expectations of regulatory agencies, FDA preferred.
Ability to interpret statistical analysis plans to develop analysis data set specifications.
SAS Certified Base and/or Advance Programmer experience preferred.
Excellent oral, written, and interpersonal communication skills.
Attention to detail and the ability to handle multiple tasks.
What we offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be at the forefront of technology that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
Exciting opportunity to join Abbott's fastest growing medical device division, Diabetes Care (ADC). Home of the FreeStyle Libre.
PRIMARY FUNCTION: Responsible for developing standards for world-wide capacity planning integrated with global supply planning, incorporating information from capacity expansion program, capital expenditures, and long term planning.
Scope of this role includes global capacity planning for finished goods and components across product categories. Includes close interaction with third party manufacturers in understanding true capacity constraints in the short and long term. Responsible to provide capacity input to IBP TPM (third party manufacturing) process and IBP demand control process.
Work cross functional with international commercial operations, finances, R&D, program and global sourcing teams to ensure market successfully new product introductions, improved product availability, and thorough understanding of component and finished goods capacity and constraints.
MAJOR RESPONSIBILITIES: Provide leadership and integration of capacity planning with global supply planning and component planning activities. Incorporate capacity plans into decision making to meet division strategies and goals for product availability and costs by taking into consideration material and capacity constraints. Responsible for running the RCCP process to streamline capacity availability. Provide input and support to the implementation of the integrated business processes and long- range plan. Work with other global supply chain organization to identify and implement supply chain and capacity optimization projects to reduce costs, lead time, and improve product availability. Support the development and implementation of planning systems. Manage the coordination and integration of data from multiple software systems to facility divisional reporting and planning activities. Integrate capacity planning with supply planning activities in connections with product introductions and discontinuation to ensure smooth and effective program execution, minimizing obsolescence while ensuring product availability. Be proactive and direct in communicating opportunities, issues and requirements ensuring that management and senior staff are current on all critical matters, with a focus on resolution alternatives, recommendations and implementation planning, costs and benefits. Maintain and develop positive relationships with commercial affiliates, global forecasting, program, finance, global sourcing and R&D to positively influence decision-making and improve performance.
QUALIFICATIONS:
Bachelor's of Science required, Masters preferred
Ideally, APICS CPIM certified
6-10 years of relevant experience in sales & operation planning, production planning, master scheduling, logistics management, inventory planning, supplier management, project management, customer service, supply planning, or demand planning
Proven leadership skills, results oriented, team player, self-starter who can operation in a dynamic and diverse environment
Extensive experience in management information systems development and implementation
Medical device background preferred
Sep 12, 2019
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
Exciting opportunity to join Abbott's fastest growing medical device division, Diabetes Care (ADC). Home of the FreeStyle Libre.
PRIMARY FUNCTION: Responsible for developing standards for world-wide capacity planning integrated with global supply planning, incorporating information from capacity expansion program, capital expenditures, and long term planning.
Scope of this role includes global capacity planning for finished goods and components across product categories. Includes close interaction with third party manufacturers in understanding true capacity constraints in the short and long term. Responsible to provide capacity input to IBP TPM (third party manufacturing) process and IBP demand control process.
Work cross functional with international commercial operations, finances, R&D, program and global sourcing teams to ensure market successfully new product introductions, improved product availability, and thorough understanding of component and finished goods capacity and constraints.
MAJOR RESPONSIBILITIES: Provide leadership and integration of capacity planning with global supply planning and component planning activities. Incorporate capacity plans into decision making to meet division strategies and goals for product availability and costs by taking into consideration material and capacity constraints. Responsible for running the RCCP process to streamline capacity availability. Provide input and support to the implementation of the integrated business processes and long- range plan. Work with other global supply chain organization to identify and implement supply chain and capacity optimization projects to reduce costs, lead time, and improve product availability. Support the development and implementation of planning systems. Manage the coordination and integration of data from multiple software systems to facility divisional reporting and planning activities. Integrate capacity planning with supply planning activities in connections with product introductions and discontinuation to ensure smooth and effective program execution, minimizing obsolescence while ensuring product availability. Be proactive and direct in communicating opportunities, issues and requirements ensuring that management and senior staff are current on all critical matters, with a focus on resolution alternatives, recommendations and implementation planning, costs and benefits. Maintain and develop positive relationships with commercial affiliates, global forecasting, program, finance, global sourcing and R&D to positively influence decision-making and improve performance.
QUALIFICATIONS:
Bachelor's of Science required, Masters preferred
Ideally, APICS CPIM certified
6-10 years of relevant experience in sales & operation planning, production planning, master scheduling, logistics management, inventory planning, supplier management, project management, customer service, supply planning, or demand planning
Proven leadership skills, results oriented, team player, self-starter who can operation in a dynamic and diverse environment
Extensive experience in management information systems development and implementation
Medical device background preferred
Overview
Reporting to the Production Planning Assistant Manager, the Production Scheduler (schedule will be Sunday to Thursday from 3:00pm-12:00am) organizes production appropriate volumes of work for work centers to meet demand and quality standards, and ensures goods are produced on time in the appropriate quantity for distribution. The production scheduler understands production procedures and ways to optimize them. They are organized and results driven with great problem solving skills to resolve demand and scheduled capacity conflicts. Advanced communication and computer skills are imperative.
The Production Scheduler works with planned and actual demand, and inventory strategies for all managed items and uses knowledge of lead times and performance capabilities to issue work on a timely basis to ensure availability. The goal is to ensure the smooth and cost-effective flow of our production operations.
Responsibilities
Create daily Production Schedule to meet demand and maintain efficiency within each department and maintain freshness and quality product. Responsible for ongoing development of production and material schedules and priorities that support strategies for Sales, inventory levels and availability of equipment/labor/materials capacity utilization.
Maintain metrics that track product flow.
Track daily actual versus planned performance reporting. Understand explanations of failures to execute production plan. Determine if and what action is required to ensure smooth operations.
Communicate schedule changes, special production runs, and maintenance requirements, etc that effect future production plans to Work Teams and Operations. Interacts with shop floor management on a daily basis to resolve issues regarding manufacturing efficiencies or additional information as requested from Manufacturing, Customer Service.
Drive planning and capacity management process improvements.
Improve the efficiencies within the planning organization.
Utilize and maintain capacity planning reports describing current status, trends, and scenarios.
Evaluation, analysis, and recommendation of enhancements to existing resources and processes to increase throughput.
Ensure that schedule related data from suppliers, production, and maintenance is provided as feedback into the planning and scheduling systems.
Data analysis and decision making to support raw material supply and finished goods demand.
May be asked to perform other duties at a lower level or higher level of proficiency.
Maintains item inventory strategy based on business criticality, forecast accuracy, required service level (availability), lead times, Min/Max levels, and EOQs.
Ensures the appropriate inventory is ordered on time and is of the appropriate volume. The buying function may also include expediting or de-expediting material as needed.
Contact suppliers, and places orders, complete purchase orders and submit to suppliers in response to product requirements.
Maintain relationships with suppliers.
Qualifications
2-5 years of Planning and Scheduling experience.
1 year of experience in a manufacturing environment preferred.
College Degree or equivalent work experience preferred.
Candidate must possess written and verbal communication proficiency.
Ability to work independently.
Experience performing capacity planning, including trend forecasting.
Proven strong innovative and analytical ability.
Must be a team player with collaboration skills.
Excellent MS office skills.
Knowledge of MRP methodologies.
Experience with various ERP/MRP software.
Proficient Microsoft Office products; strong computer skills.
Strong organizational and communication skills.
Detail-oriented, ability to multi-task and prioritize tasks with strict deadlines.
Using logic and reasoning to identify solutions to problems.
Demonstrate personal time management skills.
Shares Peets values and culture.
Able to work full-time Sunday – Thursday 3:00 pm - 12:00 am
#GD
Peet’s is proud to be an Equal Opportunity Employer
For more information about our craft and who we are please visit our website.
We look forward to hearing from you!
Sep 11, 2019
Overview
Reporting to the Production Planning Assistant Manager, the Production Scheduler (schedule will be Sunday to Thursday from 3:00pm-12:00am) organizes production appropriate volumes of work for work centers to meet demand and quality standards, and ensures goods are produced on time in the appropriate quantity for distribution. The production scheduler understands production procedures and ways to optimize them. They are organized and results driven with great problem solving skills to resolve demand and scheduled capacity conflicts. Advanced communication and computer skills are imperative.
The Production Scheduler works with planned and actual demand, and inventory strategies for all managed items and uses knowledge of lead times and performance capabilities to issue work on a timely basis to ensure availability. The goal is to ensure the smooth and cost-effective flow of our production operations.
Responsibilities
Create daily Production Schedule to meet demand and maintain efficiency within each department and maintain freshness and quality product. Responsible for ongoing development of production and material schedules and priorities that support strategies for Sales, inventory levels and availability of equipment/labor/materials capacity utilization.
Maintain metrics that track product flow.
Track daily actual versus planned performance reporting. Understand explanations of failures to execute production plan. Determine if and what action is required to ensure smooth operations.
Communicate schedule changes, special production runs, and maintenance requirements, etc that effect future production plans to Work Teams and Operations. Interacts with shop floor management on a daily basis to resolve issues regarding manufacturing efficiencies or additional information as requested from Manufacturing, Customer Service.
Drive planning and capacity management process improvements.
Improve the efficiencies within the planning organization.
Utilize and maintain capacity planning reports describing current status, trends, and scenarios.
Evaluation, analysis, and recommendation of enhancements to existing resources and processes to increase throughput.
Ensure that schedule related data from suppliers, production, and maintenance is provided as feedback into the planning and scheduling systems.
Data analysis and decision making to support raw material supply and finished goods demand.
May be asked to perform other duties at a lower level or higher level of proficiency.
Maintains item inventory strategy based on business criticality, forecast accuracy, required service level (availability), lead times, Min/Max levels, and EOQs.
Ensures the appropriate inventory is ordered on time and is of the appropriate volume. The buying function may also include expediting or de-expediting material as needed.
Contact suppliers, and places orders, complete purchase orders and submit to suppliers in response to product requirements.
Maintain relationships with suppliers.
Qualifications
2-5 years of Planning and Scheduling experience.
1 year of experience in a manufacturing environment preferred.
College Degree or equivalent work experience preferred.
Candidate must possess written and verbal communication proficiency.
Ability to work independently.
Experience performing capacity planning, including trend forecasting.
Proven strong innovative and analytical ability.
Must be a team player with collaboration skills.
Excellent MS office skills.
Knowledge of MRP methodologies.
Experience with various ERP/MRP software.
Proficient Microsoft Office products; strong computer skills.
Strong organizational and communication skills.
Detail-oriented, ability to multi-task and prioritize tasks with strict deadlines.
Using logic and reasoning to identify solutions to problems.
Demonstrate personal time management skills.
Shares Peets values and culture.
Able to work full-time Sunday – Thursday 3:00 pm - 12:00 am
#GD
Peet’s is proud to be an Equal Opportunity Employer
For more information about our craft and who we are please visit our website.
We look forward to hearing from you!
Penumbra's Marketing team is focused on building awareness among patients, physicians, and the public of new technologies and opportunities to combat some of the most devastating diseases in the world. As an Event Coordinator, you will play a key role in coordinating and managing off-site events from start to finish. You will work with a dedicated team of professionals who are committed to bringing innovation and new treatments to the widest possible audience.
What You'll Work On
Assist in the coordination of logistics for conferences and external events, including trade shows, customer events, and any other off-site events.
Promote new ideas and concepts for on-site booth design to ensure proper brand messaging and visual presence.
Travel to and supervise conferences and provide operational support, from set-up to dismantling.
Manage on-site conference logistics and assist with restaurant and conference room bookings as needed.
Communicate and maintain timeline and priorities on projects and events.
Maintain all conferences and meetings in the QuickBase or equivalent software, and perform routine audits to check for accuracy.
Ensure the Penumbra booth is adequately staffed and all devices and materials are secure.
Maintain relationships with vendors, exhibition houses, meeting societies, journals, and publications.
Partner with Product Managers to finalize brand messaging and ensure all deliverables are met per deadline.
Work closely with Finance to track all payments related to vendors.
What You Bring
Bachelor's degree in a related field, plus two years of experience in event planning.
Energized by working in a fast-paced environment, with multiple and changing priorities while maintaining strong focus on execution and results.
Ability to maintain flexibility when priorities and deadlines shift.
Willingness to engage with customers by providing assistance with demonstration on show floor.
Strong interpersonal and collaboration skills with an ability to communicate at all levels of an organization.
Excellent written and verbal communication skills, as well as strong organizational and planning skills.
Detail-oriented with excellent follow-up, budgeting, and time management skills
Adept at handling multiple complex projects simultaneously under pressure to meet tight deadlines.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Sep 11, 2019
Penumbra's Marketing team is focused on building awareness among patients, physicians, and the public of new technologies and opportunities to combat some of the most devastating diseases in the world. As an Event Coordinator, you will play a key role in coordinating and managing off-site events from start to finish. You will work with a dedicated team of professionals who are committed to bringing innovation and new treatments to the widest possible audience.
What You'll Work On
Assist in the coordination of logistics for conferences and external events, including trade shows, customer events, and any other off-site events.
Promote new ideas and concepts for on-site booth design to ensure proper brand messaging and visual presence.
Travel to and supervise conferences and provide operational support, from set-up to dismantling.
Manage on-site conference logistics and assist with restaurant and conference room bookings as needed.
Communicate and maintain timeline and priorities on projects and events.
Maintain all conferences and meetings in the QuickBase or equivalent software, and perform routine audits to check for accuracy.
Ensure the Penumbra booth is adequately staffed and all devices and materials are secure.
Maintain relationships with vendors, exhibition houses, meeting societies, journals, and publications.
Partner with Product Managers to finalize brand messaging and ensure all deliverables are met per deadline.
Work closely with Finance to track all payments related to vendors.
What You Bring
Bachelor's degree in a related field, plus two years of experience in event planning.
Energized by working in a fast-paced environment, with multiple and changing priorities while maintaining strong focus on execution and results.
Ability to maintain flexibility when priorities and deadlines shift.
Willingness to engage with customers by providing assistance with demonstration on show floor.
Strong interpersonal and collaboration skills with an ability to communicate at all levels of an organization.
Excellent written and verbal communication skills, as well as strong organizational and planning skills.
Detail-oriented with excellent follow-up, budgeting, and time management skills
Adept at handling multiple complex projects simultaneously under pressure to meet tight deadlines.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
As a key member of the Clinical Affairs team, you will participate in the analysis of clinical data to assess the safety and effectiveness of Penumbra's products. You will assist in the development and implementation of statistical methodologies, participating in the planning, design, and execution of statistical analyses. Working collaboratively with Regulatory Affairs, Medical Affairs, Medical Writing, Data Management and Clinical Operations, you will take the lead on the statistical aspects of study design, coordinating the analysis, validation, and study documentation, and on the publication of study data.
What You'll Work On
Perform statistical and descriptive data analysis using the SAS programming language for the summary and interpretation of clinical trial data.
Develop and maintain SAS code in support of descriptive and statistical analysis, including testing and documenting statistical programs; performing database quality control checks; and identifying and addressing opportunities for improvement.
Review Data Management Plan and study design specifications.
Draft and contribute to statistical analysis plans; provide additional input in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
Design and implement reports and analytic strategies based on research questions, including data summary tables, figures, and narrative summaries.
Create reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data.
Assist in the writing of publications resulting from the studies.
Provides guidance within the department to ensure general knowledge of statistical methodology for research studies.
Utilizes team members to increase work efficiency, when appropriate and such resources are available. Participates successfully in all statistical aspects of a trial/project.
Collaborates actively with Project Lead and core team to affect significant decisions regarding the trial/project.
Recognizes system-wide problems and participates constructively in seeking resolution of the problems. Takes appropriate initiative in creating solutions to issues within the statistics group
What You Bring
An appreciation for complexity, combined with a passion for clean, accurate data.
Master's degree or higher in statistics, mathematics or a related field.
The ideal candidate will have at least 4 years of experience conducting statistical analyses using SAS/R in a medical device or pharmaceutical environment.
Familiarity with relational databases and understanding of fundamental statistical methods, such as non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques.
Excellent oral, written, and interpersonal communication skills.
Working knowledge of computer programming and software programs (e.g., SAS, R) required.
Understanding of FDA regulatory requirements and ICH/GCP preferred.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Sep 11, 2019
As a key member of the Clinical Affairs team, you will participate in the analysis of clinical data to assess the safety and effectiveness of Penumbra's products. You will assist in the development and implementation of statistical methodologies, participating in the planning, design, and execution of statistical analyses. Working collaboratively with Regulatory Affairs, Medical Affairs, Medical Writing, Data Management and Clinical Operations, you will take the lead on the statistical aspects of study design, coordinating the analysis, validation, and study documentation, and on the publication of study data.
What You'll Work On
Perform statistical and descriptive data analysis using the SAS programming language for the summary and interpretation of clinical trial data.
Develop and maintain SAS code in support of descriptive and statistical analysis, including testing and documenting statistical programs; performing database quality control checks; and identifying and addressing opportunities for improvement.
Review Data Management Plan and study design specifications.
Draft and contribute to statistical analysis plans; provide additional input in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
Design and implement reports and analytic strategies based on research questions, including data summary tables, figures, and narrative summaries.
Create reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data.
Assist in the writing of publications resulting from the studies.
Provides guidance within the department to ensure general knowledge of statistical methodology for research studies.
Utilizes team members to increase work efficiency, when appropriate and such resources are available. Participates successfully in all statistical aspects of a trial/project.
Collaborates actively with Project Lead and core team to affect significant decisions regarding the trial/project.
Recognizes system-wide problems and participates constructively in seeking resolution of the problems. Takes appropriate initiative in creating solutions to issues within the statistics group
What You Bring
An appreciation for complexity, combined with a passion for clean, accurate data.
Master's degree or higher in statistics, mathematics or a related field.
The ideal candidate will have at least 4 years of experience conducting statistical analyses using SAS/R in a medical device or pharmaceutical environment.
Familiarity with relational databases and understanding of fundamental statistical methods, such as non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques.
Excellent oral, written, and interpersonal communication skills.
Working knowledge of computer programming and software programs (e.g., SAS, R) required.
Understanding of FDA regulatory requirements and ICH/GCP preferred.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
As a key member of the Clinical Affairs team, you will participate in the analysis of clinical data to assess the safety and effectiveness of Penumbra's products. You will assist in the development and implementation of statistical methodologies, participating in the planning, design, and execution of statistical analyses. Working collaboratively with Regulatory Affairs, Medical Affairs, Medical Writing, Data Management and Clinical Operations, you will take the lead on the statistical aspects of study design, coordinating the analysis, validation, and study documentation, and on the publication of study data.
What You'll Work On
Perform statistical and descriptive data analysis using the SAS programming language for the summary and interpretation of clinical trial data.
Develop and maintain SAS code in support of descriptive and statistical analysis, including testing and documenting statistical programs; performing database quality control checks; and identifying and addressing opportunities for improvement.
Review Data Management Plan and study design specifications.
Draft and contribute to statistical analysis plans; provide additional input in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
Design and implement reports and analytic strategies based on research questions, including data summary tables, figures, and narrative summaries.
Create reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data.
Assist in the writing of publications resulting from the studies.
Provides guidance within the department to ensure general knowledge of statistical methodology for research studies.
Utilizes team members to increase work efficiency, when appropriate and such resources are available. Participates successfully in all statistical aspects of a trial/project.
Collaborates actively with Project Lead and core team to affect significant decisions regarding the trial/project.
Recognizes system-wide problems and participates constructively in seeking resolution of the problems. Takes appropriate initiative in creating solutions to issues within the statistics group
What You Bring
An appreciation for complexity, combined with a passion for clean, accurate data.
Master's degree or higher in statistics, mathematics or a related field.
The ideal candidate will have at least 4 years of experience conducting statistical analyses using SAS/R in a medical device or pharmaceutical environment.
Familiarity with relational databases and understanding of fundamental statistical methods, such as non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques.
Excellent oral, written, and interpersonal communication skills.
Working knowledge of computer programming and software programs (e.g., SAS, R) required.
Understanding of FDA regulatory requirements and ICH/GCP preferred.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Sep 11, 2019
As a key member of the Clinical Affairs team, you will participate in the analysis of clinical data to assess the safety and effectiveness of Penumbra's products. You will assist in the development and implementation of statistical methodologies, participating in the planning, design, and execution of statistical analyses. Working collaboratively with Regulatory Affairs, Medical Affairs, Medical Writing, Data Management and Clinical Operations, you will take the lead on the statistical aspects of study design, coordinating the analysis, validation, and study documentation, and on the publication of study data.
What You'll Work On
Perform statistical and descriptive data analysis using the SAS programming language for the summary and interpretation of clinical trial data.
Develop and maintain SAS code in support of descriptive and statistical analysis, including testing and documenting statistical programs; performing database quality control checks; and identifying and addressing opportunities for improvement.
Review Data Management Plan and study design specifications.
Draft and contribute to statistical analysis plans; provide additional input in the analysis of clinical trial as it relates to protocol development, case report form design and data collection.
Design and implement reports and analytic strategies based on research questions, including data summary tables, figures, and narrative summaries.
Create reports for the Data Monitoring Committee to review patient accrual, overall study progress, treatment efficacy, and patient safety data.
Assist in the writing of publications resulting from the studies.
Provides guidance within the department to ensure general knowledge of statistical methodology for research studies.
Utilizes team members to increase work efficiency, when appropriate and such resources are available. Participates successfully in all statistical aspects of a trial/project.
Collaborates actively with Project Lead and core team to affect significant decisions regarding the trial/project.
Recognizes system-wide problems and participates constructively in seeking resolution of the problems. Takes appropriate initiative in creating solutions to issues within the statistics group
What You Bring
An appreciation for complexity, combined with a passion for clean, accurate data.
Master's degree or higher in statistics, mathematics or a related field.
The ideal candidate will have at least 4 years of experience conducting statistical analyses using SAS/R in a medical device or pharmaceutical environment.
Familiarity with relational databases and understanding of fundamental statistical methods, such as non-parametric analysis, linear and non-linear models, categorical data and survival analysis techniques.
Excellent oral, written, and interpersonal communication skills.
Working knowledge of computer programming and software programs (e.g., SAS, R) required.
Understanding of FDA regulatory requirements and ICH/GCP preferred.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
The Senior Medical Affairs Director provides medical oversight for the company’s RAMP (Review of Advertising, Marketing, and Promotions) and MRC (Medical Review Committee) processes, leads the RCC Strategy team with the Executive Medical Director, provides input in the protocol review process for ISTs and CTEP trials, participates in the HEOR project discussions, and ensures strategic cross-functional alignment to achieve the medical mission of supporting safe and appropriate use of our drugs.
Position Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Strategically lead MRC meetings to ensure that all scientific exchanges concerning Exelixis’ pipeline and marketed products, and disease states of interest are truthful, non-misleading, balanced, objective, non-promotional in nature and intent, and in compliance with state and federal laws.
Review Scientific Exchange Materials at MRC to ensure appropriate use, interpretation, and accuracy of the scientific and medical content in accordance with the MRC SOP [MED006-00].
Evaluate the accuracy of all scientific and medical content used in the Scientific Exchange Materials
Evaluate the accuracy and reasonableness of medical practice information in all Scientific Exchange Materials.
Evaluate appropriate interpretation and use of scientific and medical information.
Consider whether statements are supported by an appropriate level of clinical and/or scientific evidence based on published and non-published data.
Consider whether efficacy and safety statements are supported by an appropriate level of clinical and/or scientific evidence.
Evaluate whether language used in Scientific Exchange Materials is appropriate for the intended audience.
Monitor changes in the scientific, medical and clinical environment that may impact any proposed or approved Scientific Exchange Material, and inform MRC and material owner as appropriate.
Review the IST and CTEP trial protocol after Concept acceptance in alignment with the IST SOP [MED009] as well as the HEOR protocols, and provide comments as necessary.
In collaboration with the Executive Medical Director, manage the planning and implementation of the Medical Affairs RCC Strategic Meetings and deliver training presentations to MSLs and Sales Force/Market Review and approve RAMP materials to ensure all scientific information and promotional claims are medically and scientifically accurate and supported by scientifically appropriate and statistically sound evidence.
Verify the accuracy of medical and scientific data on RAMP Materials.
Analyze and advise upon the accuracy and reasonableness of medical practice information in RAMP materials.
Verify that all promotional claims, including statements about efficacy and safety, are medically and scientifically accurate and true. Ensure that these promotional claims are also supported by scientifically appropriate and statistically sound evidence.
Provide specific review comments in accordance with the RAMP SOP [REG028].
Represent the department as an attendee in RAMP Meetings, RAMP Leadership Meetings and Access teams.
Position Requirements: SUPERVISORY RESPONSIBILITIES:
Co-Lead disease-specific cross-functional team within Medical Affairs
No direct reports at this time
EDUCATION/EXPERIENCE/SKILLS:
Education:
Accredited doctorate degree in a basic-science or life-science discipline (Pharm.D., Ph.D., D.Sc., D.N.P., or M.D./D.O.) or Master’s level oncology PA or NP with active commitment towards completion of doctorate degree preferred
Experience:
Typically requires a minimum of fifteen years of related experience and/or combination of experience and education/training.
5+ years of experience in the biotech or pharmaceutical industry in the area of oncology and/or academic experience.
Experience in the area of Medical Affairs is favorable, but not required
Experience working with NCI and Cooperative Groups is a plus.
Knowledge/Skills/Abilities:
Has experience in relevant industry/profession.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Develops technical and/or business solutions to complex problems.
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
Guides the successful completion of major programs, projects and/or functions.
Leads or manages the work of others by providing guidance to subordinates or cross-functional teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
Applies strong analytical and business communication skills.
JOB COMPLEXITY:
Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company.
Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.
TRAVEL:
Telecommute available upon manager discretion.
Ability to travel domestically and internationally estimated at 25-35%
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Sep 10, 2019
The Senior Medical Affairs Director provides medical oversight for the company’s RAMP (Review of Advertising, Marketing, and Promotions) and MRC (Medical Review Committee) processes, leads the RCC Strategy team with the Executive Medical Director, provides input in the protocol review process for ISTs and CTEP trials, participates in the HEOR project discussions, and ensures strategic cross-functional alignment to achieve the medical mission of supporting safe and appropriate use of our drugs.
Position Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Strategically lead MRC meetings to ensure that all scientific exchanges concerning Exelixis’ pipeline and marketed products, and disease states of interest are truthful, non-misleading, balanced, objective, non-promotional in nature and intent, and in compliance with state and federal laws.
Review Scientific Exchange Materials at MRC to ensure appropriate use, interpretation, and accuracy of the scientific and medical content in accordance with the MRC SOP [MED006-00].
Evaluate the accuracy of all scientific and medical content used in the Scientific Exchange Materials
Evaluate the accuracy and reasonableness of medical practice information in all Scientific Exchange Materials.
Evaluate appropriate interpretation and use of scientific and medical information.
Consider whether statements are supported by an appropriate level of clinical and/or scientific evidence based on published and non-published data.
Consider whether efficacy and safety statements are supported by an appropriate level of clinical and/or scientific evidence.
Evaluate whether language used in Scientific Exchange Materials is appropriate for the intended audience.
Monitor changes in the scientific, medical and clinical environment that may impact any proposed or approved Scientific Exchange Material, and inform MRC and material owner as appropriate.
Review the IST and CTEP trial protocol after Concept acceptance in alignment with the IST SOP [MED009] as well as the HEOR protocols, and provide comments as necessary.
In collaboration with the Executive Medical Director, manage the planning and implementation of the Medical Affairs RCC Strategic Meetings and deliver training presentations to MSLs and Sales Force/Market Review and approve RAMP materials to ensure all scientific information and promotional claims are medically and scientifically accurate and supported by scientifically appropriate and statistically sound evidence.
Verify the accuracy of medical and scientific data on RAMP Materials.
Analyze and advise upon the accuracy and reasonableness of medical practice information in RAMP materials.
Verify that all promotional claims, including statements about efficacy and safety, are medically and scientifically accurate and true. Ensure that these promotional claims are also supported by scientifically appropriate and statistically sound evidence.
Provide specific review comments in accordance with the RAMP SOP [REG028].
Represent the department as an attendee in RAMP Meetings, RAMP Leadership Meetings and Access teams.
Position Requirements: SUPERVISORY RESPONSIBILITIES:
Co-Lead disease-specific cross-functional team within Medical Affairs
No direct reports at this time
EDUCATION/EXPERIENCE/SKILLS:
Education:
Accredited doctorate degree in a basic-science or life-science discipline (Pharm.D., Ph.D., D.Sc., D.N.P., or M.D./D.O.) or Master’s level oncology PA or NP with active commitment towards completion of doctorate degree preferred
Experience:
Typically requires a minimum of fifteen years of related experience and/or combination of experience and education/training.
5+ years of experience in the biotech or pharmaceutical industry in the area of oncology and/or academic experience.
Experience in the area of Medical Affairs is favorable, but not required
Experience working with NCI and Cooperative Groups is a plus.
Knowledge/Skills/Abilities:
Has experience in relevant industry/profession.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Develops technical and/or business solutions to complex problems.
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
Guides the successful completion of major programs, projects and/or functions.
Leads or manages the work of others by providing guidance to subordinates or cross-functional teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
Applies strong analytical and business communication skills.
JOB COMPLEXITY:
Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company.
Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.
TRAVEL:
Telecommute available upon manager discretion.
Ability to travel domestically and internationally estimated at 25-35%
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
The Senior Medical Affairs Director provides medical oversight for the company’s RAMP (Review of Advertising, Marketing, and Promotions) and MRC (Medical Review Committee) processes, leads the RCC Strategy team with the Executive Medical Director, provides input in the protocol review process for ISTs and CTEP trials, participates in the HEOR project discussions, and ensures strategic cross-functional alignment to achieve the medical mission of supporting safe and appropriate use of our drugs.
Position Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Strategically lead MRC meetings to ensure that all scientific exchanges concerning Exelixis’ pipeline and marketed products, and disease states of interest are truthful, non-misleading, balanced, objective, non-promotional in nature and intent, and in compliance with state and federal laws.
Review Scientific Exchange Materials at MRC to ensure appropriate use, interpretation, and accuracy of the scientific and medical content in accordance with the MRC SOP [MED006-00].
Evaluate the accuracy of all scientific and medical content used in the Scientific Exchange Materials
Evaluate the accuracy and reasonableness of medical practice information in all Scientific Exchange Materials.
Evaluate appropriate interpretation and use of scientific and medical information.
Consider whether statements are supported by an appropriate level of clinical and/or scientific evidence based on published and non-published data.
Consider whether efficacy and safety statements are supported by an appropriate level of clinical and/or scientific evidence.
Evaluate whether language used in Scientific Exchange Materials is appropriate for the intended audience.
Monitor changes in the scientific, medical and clinical environment that may impact any proposed or approved Scientific Exchange Material, and inform MRC and material owner as appropriate.
Review the IST and CTEP trial protocol after Concept acceptance in alignment with the IST SOP [MED009] as well as the HEOR protocols, and provide comments as necessary.
In collaboration with the Executive Medical Director, manage the planning and implementation of the Medical Affairs RCC Strategic Meetings and deliver training presentations to MSLs and Sales Force/Market Review and approve RAMP materials to ensure all scientific information and promotional claims are medically and scientifically accurate and supported by scientifically appropriate and statistically sound evidence.
Verify the accuracy of medical and scientific data on RAMP Materials.
Analyze and advise upon the accuracy and reasonableness of medical practice information in RAMP materials.
Verify that all promotional claims, including statements about efficacy and safety, are medically and scientifically accurate and true. Ensure that these promotional claims are also supported by scientifically appropriate and statistically sound evidence.
Provide specific review comments in accordance with the RAMP SOP [REG028].
Represent the department as an attendee in RAMP Meetings, RAMP Leadership Meetings and Access teams.
Position Requirements: SUPERVISORY RESPONSIBILITIES:
Co-Lead disease-specific cross-functional team within Medical Affairs
No direct reports at this time
EDUCATION/EXPERIENCE/SKILLS:
Education:
Accredited doctorate degree in a basic-science or life-science discipline (Pharm.D., Ph.D., D.Sc., D.N.P., or M.D./D.O.) or Master’s level oncology PA or NP with active commitment towards completion of doctorate degree preferred
Experience:
Typically requires a minimum of fifteen years of related experience and/or combination of experience and education/training.
5+ years of experience in the biotech or pharmaceutical industry in the area of oncology and/or academic experience.
Experience in the area of Medical Affairs is favorable, but not required
Experience working with NCI and Cooperative Groups is a plus.
Knowledge/Skills/Abilities:
Has experience in relevant industry/profession.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Develops technical and/or business solutions to complex problems.
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
Guides the successful completion of major programs, projects and/or functions.
Leads or manages the work of others by providing guidance to subordinates or cross-functional teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
Applies strong analytical and business communication skills.
JOB COMPLEXITY:
Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company.
Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.
TRAVEL:
Telecommute available upon manager discretion.
Ability to travel domestically and internationally estimated at 25-35%
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Sep 10, 2019
The Senior Medical Affairs Director provides medical oversight for the company’s RAMP (Review of Advertising, Marketing, and Promotions) and MRC (Medical Review Committee) processes, leads the RCC Strategy team with the Executive Medical Director, provides input in the protocol review process for ISTs and CTEP trials, participates in the HEOR project discussions, and ensures strategic cross-functional alignment to achieve the medical mission of supporting safe and appropriate use of our drugs.
Position Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Strategically lead MRC meetings to ensure that all scientific exchanges concerning Exelixis’ pipeline and marketed products, and disease states of interest are truthful, non-misleading, balanced, objective, non-promotional in nature and intent, and in compliance with state and federal laws.
Review Scientific Exchange Materials at MRC to ensure appropriate use, interpretation, and accuracy of the scientific and medical content in accordance with the MRC SOP [MED006-00].
Evaluate the accuracy of all scientific and medical content used in the Scientific Exchange Materials
Evaluate the accuracy and reasonableness of medical practice information in all Scientific Exchange Materials.
Evaluate appropriate interpretation and use of scientific and medical information.
Consider whether statements are supported by an appropriate level of clinical and/or scientific evidence based on published and non-published data.
Consider whether efficacy and safety statements are supported by an appropriate level of clinical and/or scientific evidence.
Evaluate whether language used in Scientific Exchange Materials is appropriate for the intended audience.
Monitor changes in the scientific, medical and clinical environment that may impact any proposed or approved Scientific Exchange Material, and inform MRC and material owner as appropriate.
Review the IST and CTEP trial protocol after Concept acceptance in alignment with the IST SOP [MED009] as well as the HEOR protocols, and provide comments as necessary.
In collaboration with the Executive Medical Director, manage the planning and implementation of the Medical Affairs RCC Strategic Meetings and deliver training presentations to MSLs and Sales Force/Market Review and approve RAMP materials to ensure all scientific information and promotional claims are medically and scientifically accurate and supported by scientifically appropriate and statistically sound evidence.
Verify the accuracy of medical and scientific data on RAMP Materials.
Analyze and advise upon the accuracy and reasonableness of medical practice information in RAMP materials.
Verify that all promotional claims, including statements about efficacy and safety, are medically and scientifically accurate and true. Ensure that these promotional claims are also supported by scientifically appropriate and statistically sound evidence.
Provide specific review comments in accordance with the RAMP SOP [REG028].
Represent the department as an attendee in RAMP Meetings, RAMP Leadership Meetings and Access teams.
Position Requirements: SUPERVISORY RESPONSIBILITIES:
Co-Lead disease-specific cross-functional team within Medical Affairs
No direct reports at this time
EDUCATION/EXPERIENCE/SKILLS:
Education:
Accredited doctorate degree in a basic-science or life-science discipline (Pharm.D., Ph.D., D.Sc., D.N.P., or M.D./D.O.) or Master’s level oncology PA or NP with active commitment towards completion of doctorate degree preferred
Experience:
Typically requires a minimum of fifteen years of related experience and/or combination of experience and education/training.
5+ years of experience in the biotech or pharmaceutical industry in the area of oncology and/or academic experience.
Experience in the area of Medical Affairs is favorable, but not required
Experience working with NCI and Cooperative Groups is a plus.
Knowledge/Skills/Abilities:
Has experience in relevant industry/profession.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Develops technical and/or business solutions to complex problems.
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
Guides the successful completion of major programs, projects and/or functions.
Leads or manages the work of others by providing guidance to subordinates or cross-functional teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
Applies strong analytical and business communication skills.
JOB COMPLEXITY:
Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company.
Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
Creates formal networks involving coordination among groups. Regularly interacts with executives and/or major customers.
TRAVEL:
Telecommute available upon manager discretion.
Ability to travel domestically and internationally estimated at 25-35%
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Enter the world of online marketing via a bizdev role. We have a bizdev team in Manila and also require a San Francisco presence. We are providing native widgets to web and software publishers in a 60B industry of content monetization.
Aug 28, 2019
Enter the world of online marketing via a bizdev role. We have a bizdev team in Manila and also require a San Francisco presence. We are providing native widgets to web and software publishers in a 60B industry of content monetization.
The most popular and valued employee in any organization is the person who can quickly resolve technology issues with skill and a helpful attitude. As IT Support Specialist II at Penumbra, you will assist employees with information technology requests involving PC, Mac or mobile devices; local and SaaS applications; and network and enterprise IT services. You will coordinate with internal clients to troubleshoot and resolve IT end user service issues, working closely with other IT teams to ensure the highest levels of operational excellence and client satisfaction.
What You'll Work On
Provide solutions to technical issues for in-scope IT services.
Maintain the IT ticketing system, ensuring that open tickets are resolved or escalated promptly.
Respond to incoming IT service requests across multiple real-time intake channels (web, e-mail, chat, phone, walk-up).
Maintain inventory of laptops, desktops and other devices; recommend purchases based on anticipated needs.
Manage user and computer accounts for the domain and IT services·
Actively participate as a global IT member and participate on global projects when needed.
What You Bring
A knack for diagnosing problems and offering solutions.
High level of proficiency in standard office software tools (Microsoft Office and Mac) , AV applications, VPN, and Wi-Fi.
Basic understanding of Windows Active Directory, Group Policy, DNS, DHCP, RDP, printing, and management of user accounts, distribution lists, and security groups.
Familiarity with remote systems management and configuration tools such as Microsoft SCCM to deploy software or connect to remote PC's.
Bachelor’s degree and three to five years IT support experience, or an equivalent combination of education and experience.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Aug 27, 2019
The most popular and valued employee in any organization is the person who can quickly resolve technology issues with skill and a helpful attitude. As IT Support Specialist II at Penumbra, you will assist employees with information technology requests involving PC, Mac or mobile devices; local and SaaS applications; and network and enterprise IT services. You will coordinate with internal clients to troubleshoot and resolve IT end user service issues, working closely with other IT teams to ensure the highest levels of operational excellence and client satisfaction.
What You'll Work On
Provide solutions to technical issues for in-scope IT services.
Maintain the IT ticketing system, ensuring that open tickets are resolved or escalated promptly.
Respond to incoming IT service requests across multiple real-time intake channels (web, e-mail, chat, phone, walk-up).
Maintain inventory of laptops, desktops and other devices; recommend purchases based on anticipated needs.
Manage user and computer accounts for the domain and IT services·
Actively participate as a global IT member and participate on global projects when needed.
What You Bring
A knack for diagnosing problems and offering solutions.
High level of proficiency in standard office software tools (Microsoft Office and Mac) , AV applications, VPN, and Wi-Fi.
Basic understanding of Windows Active Directory, Group Policy, DNS, DHCP, RDP, printing, and management of user accounts, distribution lists, and security groups.
Familiarity with remote systems management and configuration tools such as Microsoft SCCM to deploy software or connect to remote PC's.
Bachelor’s degree and three to five years IT support experience, or an equivalent combination of education and experience.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
The most popular and valued employee in any organization is the person who can quickly resolve technology issues with skill and a helpful attitude. As IT Support Specialist II at Penumbra, you will assist employees with information technology requests involving PC, Mac or mobile devices; local and SaaS applications; and network and enterprise IT services. You will coordinate with internal clients to troubleshoot and resolve IT end user service issues, working closely with other IT teams to ensure the highest levels of operational excellence and client satisfaction.
What You'll Work On
Provide solutions to technical issues for in-scope IT services.
Maintain the IT ticketing system, ensuring that open tickets are resolved or escalated promptly.
Respond to incoming IT service requests across multiple real-time intake channels (web, e-mail, chat, phone, walk-up).
Maintain inventory of laptops, desktops and other devices; recommend purchases based on anticipated needs.
Manage user and computer accounts for the domain and IT services·
Actively participate as a global IT member and participate on global projects when needed.
What You Bring
A knack for diagnosing problems and offering solutions.
High level of proficiency in standard office software tools (Microsoft Office and Mac) , AV applications, VPN, and Wi-Fi.
Basic understanding of Windows Active Directory, Group Policy, DNS, DHCP, RDP, printing, and management of user accounts, distribution lists, and security groups.
Familiarity with remote systems management and configuration tools such as Microsoft SCCM to deploy software or connect to remote PC's.
Bachelor’s degree and three to five years IT support experience, or an equivalent combination of education and experience.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
Aug 27, 2019
The most popular and valued employee in any organization is the person who can quickly resolve technology issues with skill and a helpful attitude. As IT Support Specialist II at Penumbra, you will assist employees with information technology requests involving PC, Mac or mobile devices; local and SaaS applications; and network and enterprise IT services. You will coordinate with internal clients to troubleshoot and resolve IT end user service issues, working closely with other IT teams to ensure the highest levels of operational excellence and client satisfaction.
What You'll Work On
Provide solutions to technical issues for in-scope IT services.
Maintain the IT ticketing system, ensuring that open tickets are resolved or escalated promptly.
Respond to incoming IT service requests across multiple real-time intake channels (web, e-mail, chat, phone, walk-up).
Maintain inventory of laptops, desktops and other devices; recommend purchases based on anticipated needs.
Manage user and computer accounts for the domain and IT services·
Actively participate as a global IT member and participate on global projects when needed.
What You Bring
A knack for diagnosing problems and offering solutions.
High level of proficiency in standard office software tools (Microsoft Office and Mac) , AV applications, VPN, and Wi-Fi.
Basic understanding of Windows Active Directory, Group Policy, DNS, DHCP, RDP, printing, and management of user accounts, distribution lists, and security groups.
Familiarity with remote systems management and configuration tools such as Microsoft SCCM to deploy software or connect to remote PC's.
Bachelor’s degree and three to five years IT support experience, or an equivalent combination of education and experience.
What We Offer
A collaborative teamwork environment where learning is constant and performance is rewarded.
The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets medical devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs. Penumbra sells its products to hospitals and clinics primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra P logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
