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SuperOffice
Superoffice.com is a leading provider of customer relationship management (CRM) software and solutions. The website serves as a platform to showcase their products, features, and services. Superoffice.com offers a comprehensive suite of CRM tools for sales, marketing, and customer service teams to streamline and optimize their operations. With a user-friendly interface and advanced functionality, their CRM software enables businesses to effectively manage customer interactions, enhance communication, and drive sales growth. The website also provides valuable resources such as blog articles, whitepapers, and webinars to help businesses stay updated with the latest CRM trends and best practices. Overall, Superoffice.com is an essential destination for businesses seeking innovative CRM solutions.
Get inspiration from 5 practical examples of how we use web forms on our site. Plus, we share form optimization tips based on an analysis of 1.1 million form visitors (and what makes them convert!).superoffice.comSince 2012, SuperOffice has rolled out dozens of web forms for sales, marketing and product development, capturing the contact information for more than 135,000 business leads.
When routine tasks are taken care of, processes streamlined and access to customer information is in one place, salespeople can take informed decisions and focus on generating revenue.superoffice.comSuperOffice Sales is designed to help salespeople succeed in reaching their revenue targets and building strong, profitable relationships with customers.
Mobile apps for iPhone and Android are available. On 14 April 2020, SuperOffice announced its acquisition by Danish investment firm Axcel. [6]en.wikipedia.orgSuperOffice has both an on-premises version which runs on Windows and Web platforms, as well as a software-as-a-service solution called "SuperOffice CRM Online".
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EncryptedSite is Encrypted
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CountryHosted in Sweden
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Latitude\Longitude59.3247 / 18.056 Google Map
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Traffic rank#17,969 Site Rank
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Site age28 yrs old
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Site Owner informationWhois info
Website is Safe
Site is not blacklisted
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FoundedOslo, Norway,(1990)
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HeadquartersOslo, Norway
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Key peopleUne Amundsen, Chairman of the Board; Gisle Jentoft, CEO; Guttorm Nielsen, Chief Product Office, Ole Vormeland, CFO
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Number of employees250
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ProductsCRM
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TypePrivate company
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IndustryComputer software
Traffic rank
#17,969
#17,969
Site age
28 yrs
28 yrs
Location
Sweden
Sweden
Popular Questions for SuperOffice
Newest job postings for SuperOffice
via Science Careers
posted_at: 19 days agoschedule_type: Full-timework_from_home: 1
U.S. Department of Health and Human Services (HHS)
Food and Drug Administration (FDA...
Center for Biologics Evaluation and Research (CBER)
Office of Therapeutic Products (OTP)
Area of Consideration: The Public.
United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.
Series: 0602 (Physician)
Telework Eligible: Yes
Cures Band(s): Band
U.S. Department of Health and Human Services (HHS)
Food and Drug Administration (FDA...
Center for Biologics Evaluation and Research (CBER)
Office of Therapeutic Products (OTP)
Area of Consideration: The Public.
United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.
Series: 0602 (Physician)
Telework Eligible: Yes
Cures Band(s): Band H
Full Performance Band Level: Band H
Travel Requirements: 25% or less
Relocation Expenses Reimbursement: You may qualify for reimbursement of relocation expenses in accordance with agency policy.
This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career- conditional appointment and compensated under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective.
The mission of the Center for Biologics Evaluation and Research (CBER) is to protect and enhance the public health through the regulation of biological and related products by ensuring that these products are safe and effective and available to those who need them. Biological products often represent cutting-edge biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have few or no other treatment options.
The Office of Therapeutic Products (OTP) is a newly established Super Office within CBER. The mission of OTP is to is to promote public health through a data-driven process to provide regulatory oversight that helps ensure medical products are safe and effective. OTP oversees development and regulation for a wide variety of products, including cells, tissues, and gene therapies, protein products derived from blood and their recombinant analogues, along with certain medical devices used in the production of these products. In addition to regulatory review of product quality, safety and effectiveness, the Super Office conducts applied scientific research related to the products that it regulates, contributes to the development of relevant regulatory policy, and supports other agency and center components involved in ensuring compliance with agency biologics regulations.
Duties/Responsibilities
As the Super Office Director of OTP in CBER, the incumbent provides executive leadership to the six offices within the Super Office and to the Immediate Office of the Director (IOD) regarding the review of regulatory submissions for quality, safety and effectiveness, for the conduct of applied scientific research and relevant regulatory policy. Manages highly complex and difficult assignments of national and international scope and significance, as well as additional related duties as noted below.
• Oversees the various offices and programs within the Super Office, which involves applying a science-based approach in support of regulatory decision-making regarding clinical applications, the conduct of applied scientific research, and the development of regulatory policy; supports compliance and enforcement activities related to regulated products; collaborates with other Center and Agency units requiring expertise in therapeutic product evaluation.
• Supervises the various Office Directors and the Immediate Office in planning, managing, organizing, and directing regulatory review operations, and research activities of the Super Office as carried out by the Office Directors and highly trained and skilled staff (Immediate Office and support staff).
• Leads, prepares, coordinates, and attends critical sponsor/internal meetings, supports, and promotes leadership, management, and reviewer development.
• Advances new policy initiatives related to regulated products, proposing and developing guidance, changes in regulations, and legislative initiatives, as appropriate, based on the emerging science.
• Directs the implementation of new laws and regulations which affect the mission of the Super Office including initiating and implementing new policies, systems, procedures, and organizational structures.
• Develops and implements Super Office policies and plans, makes critical decisions, and provides expert advice and counsel on cost-effective use of all resources including budget and manpower.
• Oversees the development of core competencies of review staff in the Super Office to maintain and render outstanding regulatory review, advice, policy, and publications and is responsible for identifying new scientific initiatives.
• Applies administrative and program management principles and skills to carry out the mission of the Super Office and addresses and solves challenging and often precedent- setting problems. Seeks and develops the most cost effective and fiscally responsible methods to manage and lead day to day operations.
• Represents the Super Office in dealing and negotiating with individuals representing organizations such as the Congress; other Federal agencies; State, local, and foreign governments; the regulated industry; and professional societies.
• In consultation with the Center Director, initiates and participates fully in discussions and decisions concerning Super Office plans, programs, and activities, both in strategic planning and implementation. Provides authoritative advice and assessments of the impact of actual and proposed Administration or Congressional actions on the program segments, functions, and activities of the division.
• Serves as subject matter expert and is a recognized authority and senior level expert.
Supervisory Duties:
Organizational Management: Manages a Super Office currently with less than 500 positions.
Program Management: Runs two or more multi-disciplinary programs in the Center. Identifies high-level activities needed to achieve desired outcomes. Shares in the strategic oversight and implementation of Center goals in collaboration with the Center Director.
Resource Management: Monitors and reports on resources needed to run a Super Office or one or more portfolios in the Center.
Personnel Performance Management: Counsels and rates immediate subordinates.
Human Capital Management: Identifies organizational capability gaps.
Education Requirement:
Candidates must possess the required individual occupational requirements to qualify for the appropriate series applicable to the position. Please use the following link to determine the series for which you qualify: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/#url=List-by-Occupational-Series
Desired Education:
The ideal candidate should possess a medical degree from an accredited institution and potentially another research doctoral degree such as a Ph.D. or one widely recognized in U.S. academe as equivalent to a Ph.D.
Professional Experience:
Our ideal candidate will possess:
• Ability to provide visionary leadership for a scientific and technical program.
• Ability to manage a diverse workforce of scientific and technical professions.
• Ability to evaluate the quality, safety, and effectiveness of biologic products based.
• Ability to develop regulatory policy initiatives related to medical products.
• Ability to function within a regulatory environment and problem solve to meet challenging demands.
• An understanding of Federal Regulations related to the work of the Center for Biologics Evaluation and Research.
• Prior senior leadership experience and excellent interpersonal skills.
Desired Professional Experience:
• Provides scientific and technical leadership, direction, and supervision to a multidisciplinary scientific, engineering, and medical science staff.
• Provides expert technical and scientific guidance/assessment to senior leadership on complex, precedent setting, and/or controversial issues involving policies related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.
• Knowledge and understanding of the provisions, limitations, and practical applications of FDA issues, policies, laws, and regulations related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.
• Collaborates with other scientific, technical, and regulatory staff to develop and implement policy initiatives related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.
• Ability to communicate complex scientific concepts to a diverse audience (examples include, policy makers, manufacturers, scientists, universities, and the public).
Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.
How to Apply: Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), copy of your unofficial transcripts (if applicable), copy of your active medical license/s (if applicable), copy of your board certification/s (if applicable), SF50 (if applicable), latest signed PMAP (if applicable), and letter of interest with “CURES CBER/OTP Super Office Director” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through May 31, 2023.
Announcement Contact: For questions regarding this Cures position, please contact CBERHumanCapital@fda.hhs.gov.
The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.
FDA is an equal opportunity employer Show more details...
Food and Drug Administration (FDA...
Center for Biologics Evaluation and Research (CBER)
Office of Therapeutic Products (OTP)
Area of Consideration: The Public.
United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.
Series: 0602 (Physician)
Telework Eligible: Yes
Cures Band(s): Band H
Full Performance Band Level: Band H
Travel Requirements: 25% or less
Relocation Expenses Reimbursement: You may qualify for reimbursement of relocation expenses in accordance with agency policy.
This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career- conditional appointment and compensated under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective.
The mission of the Center for Biologics Evaluation and Research (CBER) is to protect and enhance the public health through the regulation of biological and related products by ensuring that these products are safe and effective and available to those who need them. Biological products often represent cutting-edge biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have few or no other treatment options.
The Office of Therapeutic Products (OTP) is a newly established Super Office within CBER. The mission of OTP is to is to promote public health through a data-driven process to provide regulatory oversight that helps ensure medical products are safe and effective. OTP oversees development and regulation for a wide variety of products, including cells, tissues, and gene therapies, protein products derived from blood and their recombinant analogues, along with certain medical devices used in the production of these products. In addition to regulatory review of product quality, safety and effectiveness, the Super Office conducts applied scientific research related to the products that it regulates, contributes to the development of relevant regulatory policy, and supports other agency and center components involved in ensuring compliance with agency biologics regulations.
Duties/Responsibilities
As the Super Office Director of OTP in CBER, the incumbent provides executive leadership to the six offices within the Super Office and to the Immediate Office of the Director (IOD) regarding the review of regulatory submissions for quality, safety and effectiveness, for the conduct of applied scientific research and relevant regulatory policy. Manages highly complex and difficult assignments of national and international scope and significance, as well as additional related duties as noted below.
• Oversees the various offices and programs within the Super Office, which involves applying a science-based approach in support of regulatory decision-making regarding clinical applications, the conduct of applied scientific research, and the development of regulatory policy; supports compliance and enforcement activities related to regulated products; collaborates with other Center and Agency units requiring expertise in therapeutic product evaluation.
• Supervises the various Office Directors and the Immediate Office in planning, managing, organizing, and directing regulatory review operations, and research activities of the Super Office as carried out by the Office Directors and highly trained and skilled staff (Immediate Office and support staff).
• Leads, prepares, coordinates, and attends critical sponsor/internal meetings, supports, and promotes leadership, management, and reviewer development.
• Advances new policy initiatives related to regulated products, proposing and developing guidance, changes in regulations, and legislative initiatives, as appropriate, based on the emerging science.
• Directs the implementation of new laws and regulations which affect the mission of the Super Office including initiating and implementing new policies, systems, procedures, and organizational structures.
• Develops and implements Super Office policies and plans, makes critical decisions, and provides expert advice and counsel on cost-effective use of all resources including budget and manpower.
• Oversees the development of core competencies of review staff in the Super Office to maintain and render outstanding regulatory review, advice, policy, and publications and is responsible for identifying new scientific initiatives.
• Applies administrative and program management principles and skills to carry out the mission of the Super Office and addresses and solves challenging and often precedent- setting problems. Seeks and develops the most cost effective and fiscally responsible methods to manage and lead day to day operations.
• Represents the Super Office in dealing and negotiating with individuals representing organizations such as the Congress; other Federal agencies; State, local, and foreign governments; the regulated industry; and professional societies.
• In consultation with the Center Director, initiates and participates fully in discussions and decisions concerning Super Office plans, programs, and activities, both in strategic planning and implementation. Provides authoritative advice and assessments of the impact of actual and proposed Administration or Congressional actions on the program segments, functions, and activities of the division.
• Serves as subject matter expert and is a recognized authority and senior level expert.
Supervisory Duties:
Organizational Management: Manages a Super Office currently with less than 500 positions.
Program Management: Runs two or more multi-disciplinary programs in the Center. Identifies high-level activities needed to achieve desired outcomes. Shares in the strategic oversight and implementation of Center goals in collaboration with the Center Director.
Resource Management: Monitors and reports on resources needed to run a Super Office or one or more portfolios in the Center.
Personnel Performance Management: Counsels and rates immediate subordinates.
Human Capital Management: Identifies organizational capability gaps.
Education Requirement:
Candidates must possess the required individual occupational requirements to qualify for the appropriate series applicable to the position. Please use the following link to determine the series for which you qualify: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/#url=List-by-Occupational-Series
Desired Education:
The ideal candidate should possess a medical degree from an accredited institution and potentially another research doctoral degree such as a Ph.D. or one widely recognized in U.S. academe as equivalent to a Ph.D.
Professional Experience:
Our ideal candidate will possess:
• Ability to provide visionary leadership for a scientific and technical program.
• Ability to manage a diverse workforce of scientific and technical professions.
• Ability to evaluate the quality, safety, and effectiveness of biologic products based.
• Ability to develop regulatory policy initiatives related to medical products.
• Ability to function within a regulatory environment and problem solve to meet challenging demands.
• An understanding of Federal Regulations related to the work of the Center for Biologics Evaluation and Research.
• Prior senior leadership experience and excellent interpersonal skills.
Desired Professional Experience:
• Provides scientific and technical leadership, direction, and supervision to a multidisciplinary scientific, engineering, and medical science staff.
• Provides expert technical and scientific guidance/assessment to senior leadership on complex, precedent setting, and/or controversial issues involving policies related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.
• Knowledge and understanding of the provisions, limitations, and practical applications of FDA issues, policies, laws, and regulations related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.
• Collaborates with other scientific, technical, and regulatory staff to develop and implement policy initiatives related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.
• Ability to communicate complex scientific concepts to a diverse audience (examples include, policy makers, manufacturers, scientists, universities, and the public).
Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.
How to Apply: Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), copy of your unofficial transcripts (if applicable), copy of your active medical license/s (if applicable), copy of your board certification/s (if applicable), SF50 (if applicable), latest signed PMAP (if applicable), and letter of interest with “CURES CBER/OTP Super Office Director” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through May 31, 2023.
Announcement Contact: For questions regarding this Cures position, please contact CBERHumanCapital@fda.hhs.gov.
The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.
FDA is an equal opportunity employer Show more details...
via ASCO Career Center
posted_at: 19 days agoschedule_type: Full-time
U.S. Department of Health and Human Services (HHS)
Food and Drug Administration (FDA...
Center for Biologics Evaluation and Research (CBER)
Office of Therapeutic Products (OTP)
Area of Consideration: The Public.
United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.
Series: 0602 (Physician)
Telework Eligible: Yes
Cures Band(s): Band
U.S. Department of Health and Human Services (HHS)
Food and Drug Administration (FDA...
Center for Biologics Evaluation and Research (CBER)
Office of Therapeutic Products (OTP)
Area of Consideration: The Public.
United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.
Series: 0602 (Physician)
Telework Eligible: Yes
Cures Band(s): Band H
Full Performance Band Level: Band H
Travel Requirements: 25% or less
Relocation Expenses Reimbursement: You may qualify for reimbursement of relocation expenses in accordance with agency policy.
This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career- conditional appointment and compensated under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective.
The mission of the Center for Biologics Evaluation and Research (CBER) is to protect and enhance the public health through the regulation of biological and related products by ensuring that these products are safe and effective and available to those who need them. Biological products often represent cutting-edge biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have few or no other treatment options.
The Office of Therapeutic Products (OTP) is a newly established Super Office within CBER. The mission of OTP is to is to promote public health through a data-driven process to provide regulatory oversight that helps ensure medical products are safe and effective. OTP oversees development and regulation for a wide variety of products, including cells, tissues, and gene therapies, protein products derived from blood and their recombinant analogues, along with certain medical devices used in the production of these products. In addition to regulatory review of product quality, safety and effectiveness, the Super Office conducts applied scientific research related to the products that it regulates, contributes to the development of relevant regulatory policy, and supports other agency and center components involved in ensuring compliance with agency biologics regulations.
Duties/Responsibilities
As the Super Office Director of OTP in CBER, the incumbent provides executive leadership to the six offices within the Super Office and to the Immediate Office of the Director (IOD) regarding the review of regulatory submissions for quality, safety and effectiveness, for the conduct of applied scientific research and relevant regulatory policy. Manages highly complex and difficult assignments of national and international scope and significance, as well as additional related duties as noted below.
• Oversees the various offices and programs within the Super Office, which involves applying a science-based approach in support of regulatory decision-making regarding clinical applications, the conduct of applied scientific research, and the development of regulatory policy; supports compliance and enforcement activities related to regulated products; collaborates with other Center and Agency units requiring expertise in therapeutic product evaluation.
• Supervises the various Office Directors and the Immediate Office in planning, managing, organizing, and directing regulatory review operations, and research activities of the Super Office as carried out by the Office Directors and highly trained and skilled staff (Immediate Office and support staff).
• Leads, prepares, coordinates, and attends critical sponsor/internal meetings, supports, and promotes leadership, management, and reviewer development.
• Advances new policy initiatives related to regulated products, proposing and developing guidance, changes in regulations, and legislative initiatives, as appropriate, based on the emerging science.
• Directs the implementation of new laws and regulations which affect the mission of the Super Office including initiating and implementing new policies, systems, procedures, and organizational structures.
• Develops and implements Super Office policies and plans, makes critical decisions, and provides expert advice and counsel on cost-effective use of all resources including budget and manpower.
• Oversees the development of core competencies of review staff in the Super Office to maintain and render outstanding regulatory review, advice, policy, and publications and is responsible for identifying new scientific initiatives.
• Applies administrative and program management principles and skills to carry out the mission of the Super Office and addresses and solves challenging and often precedent- setting problems. Seeks and develops the most cost effective and fiscally responsible methods to manage and lead day to day operations.
• Represents the Super Office in dealing and negotiating with individuals representing organizations such as the Congress; other Federal agencies; State, local, and foreign governments; the regulated industry; and professional societies.
• In consultation with the Center Director, initiates and participates fully in discussions and decisions concerning Super Office plans, programs, and activities, both in strategic planning and implementation. Provides authoritative advice and assessments of the impact of actual and proposed Administration or Congressional actions on the program segments, functions, and activities of the division.
• Serves as subject matter expert and is a recognized authority and senior level expert.
Supervisory Duties:
Organizational Management: Manages a Super Office currently with less than 500 positions.
Program Management: Runs two or more multi-disciplinary programs in the Center. Identifies high-level activities needed to achieve desired outcomes. Shares in the strategic oversight and implementation of Center goals in collaboration with the Center Director.
Resource Management: Monitors and reports on resources needed to run a Super Office or one or more portfolios in the Center.
Personnel Performance Management: Counsels and rates immediate subordinates.
Human Capital Management: Identifies organizational capability gaps.
Education Requirement:
Candidates must possess the required individual occupational requirements to qualify for the appropriate series applicable to the position. Please use the following link to determine the series for which you qualify: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/#url=List-by-Occupational-Series
Desired Education:
The ideal candidate should possess a medical degree from an accredited institution and potentially another research doctoral degree such as a Ph.D. or one widely recognized in U.S. academe as equivalent to a Ph.D.
Professional Experience:
Our ideal candidate will possess:
• Ability to provide visionary leadership for a scientific and technical program.
• Ability to manage a diverse workforce of scientific and technical professions.
• Ability to evaluate the quality, safety, and effectiveness of biologic products based.
• Ability to develop regulatory policy initiatives related to medical products.
• Ability to function within a regulatory environment and problem solve to meet challenging demands.
• An understanding of Federal Regulations related to the work of the Center for Biologics Evaluation and Research.
• Prior senior leadership experience and excellent interpersonal skills.
Desired Professional Experience:
• Provides scientific and technical leadership, direction, and supervision to a multidisciplinary scientific, engineering, and medical science staff.
• Provides expert technical and scientific guidance/assessment to senior leadership on complex, precedent setting, and/or controversial issues involving policies related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.
• Knowledge and understanding of the provisions, limitations, and practical applications of FDA issues, policies, laws, and regulations related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.
• Collaborates with other scientific, technical, and regulatory staff to develop and implement policy initiatives related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.
• Ability to communicate complex scientific concepts to a diverse audience (examples include, policy makers, manufacturers, scientists, universities, and the public).
Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.
How to Apply: Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), copy of your unofficial transcripts (if applicable), copy of your active medical license/s (if applicable), copy of your board certification/s (if applicable), SF50 (if applicable), latest signed PMAP (if applicable), and letter of interest with “CURES CBER/OTP Super Office Director” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through May 31, 2023.
Announcement Contact: For questions regarding this Cures position, please contact CBERHumanCapital@fda.hhs.gov.
The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.
FDA is an equal opportunity employer Show more details...
Food and Drug Administration (FDA...
Center for Biologics Evaluation and Research (CBER)
Office of Therapeutic Products (OTP)
Area of Consideration: The Public.
United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.
Series: 0602 (Physician)
Telework Eligible: Yes
Cures Band(s): Band H
Full Performance Band Level: Band H
Travel Requirements: 25% or less
Relocation Expenses Reimbursement: You may qualify for reimbursement of relocation expenses in accordance with agency policy.
This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career- conditional appointment and compensated under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective.
The mission of the Center for Biologics Evaluation and Research (CBER) is to protect and enhance the public health through the regulation of biological and related products by ensuring that these products are safe and effective and available to those who need them. Biological products often represent cutting-edge biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have few or no other treatment options.
The Office of Therapeutic Products (OTP) is a newly established Super Office within CBER. The mission of OTP is to is to promote public health through a data-driven process to provide regulatory oversight that helps ensure medical products are safe and effective. OTP oversees development and regulation for a wide variety of products, including cells, tissues, and gene therapies, protein products derived from blood and their recombinant analogues, along with certain medical devices used in the production of these products. In addition to regulatory review of product quality, safety and effectiveness, the Super Office conducts applied scientific research related to the products that it regulates, contributes to the development of relevant regulatory policy, and supports other agency and center components involved in ensuring compliance with agency biologics regulations.
Duties/Responsibilities
As the Super Office Director of OTP in CBER, the incumbent provides executive leadership to the six offices within the Super Office and to the Immediate Office of the Director (IOD) regarding the review of regulatory submissions for quality, safety and effectiveness, for the conduct of applied scientific research and relevant regulatory policy. Manages highly complex and difficult assignments of national and international scope and significance, as well as additional related duties as noted below.
• Oversees the various offices and programs within the Super Office, which involves applying a science-based approach in support of regulatory decision-making regarding clinical applications, the conduct of applied scientific research, and the development of regulatory policy; supports compliance and enforcement activities related to regulated products; collaborates with other Center and Agency units requiring expertise in therapeutic product evaluation.
• Supervises the various Office Directors and the Immediate Office in planning, managing, organizing, and directing regulatory review operations, and research activities of the Super Office as carried out by the Office Directors and highly trained and skilled staff (Immediate Office and support staff).
• Leads, prepares, coordinates, and attends critical sponsor/internal meetings, supports, and promotes leadership, management, and reviewer development.
• Advances new policy initiatives related to regulated products, proposing and developing guidance, changes in regulations, and legislative initiatives, as appropriate, based on the emerging science.
• Directs the implementation of new laws and regulations which affect the mission of the Super Office including initiating and implementing new policies, systems, procedures, and organizational structures.
• Develops and implements Super Office policies and plans, makes critical decisions, and provides expert advice and counsel on cost-effective use of all resources including budget and manpower.
• Oversees the development of core competencies of review staff in the Super Office to maintain and render outstanding regulatory review, advice, policy, and publications and is responsible for identifying new scientific initiatives.
• Applies administrative and program management principles and skills to carry out the mission of the Super Office and addresses and solves challenging and often precedent- setting problems. Seeks and develops the most cost effective and fiscally responsible methods to manage and lead day to day operations.
• Represents the Super Office in dealing and negotiating with individuals representing organizations such as the Congress; other Federal agencies; State, local, and foreign governments; the regulated industry; and professional societies.
• In consultation with the Center Director, initiates and participates fully in discussions and decisions concerning Super Office plans, programs, and activities, both in strategic planning and implementation. Provides authoritative advice and assessments of the impact of actual and proposed Administration or Congressional actions on the program segments, functions, and activities of the division.
• Serves as subject matter expert and is a recognized authority and senior level expert.
Supervisory Duties:
Organizational Management: Manages a Super Office currently with less than 500 positions.
Program Management: Runs two or more multi-disciplinary programs in the Center. Identifies high-level activities needed to achieve desired outcomes. Shares in the strategic oversight and implementation of Center goals in collaboration with the Center Director.
Resource Management: Monitors and reports on resources needed to run a Super Office or one or more portfolios in the Center.
Personnel Performance Management: Counsels and rates immediate subordinates.
Human Capital Management: Identifies organizational capability gaps.
Education Requirement:
Candidates must possess the required individual occupational requirements to qualify for the appropriate series applicable to the position. Please use the following link to determine the series for which you qualify: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/#url=List-by-Occupational-Series
Desired Education:
The ideal candidate should possess a medical degree from an accredited institution and potentially another research doctoral degree such as a Ph.D. or one widely recognized in U.S. academe as equivalent to a Ph.D.
Professional Experience:
Our ideal candidate will possess:
• Ability to provide visionary leadership for a scientific and technical program.
• Ability to manage a diverse workforce of scientific and technical professions.
• Ability to evaluate the quality, safety, and effectiveness of biologic products based.
• Ability to develop regulatory policy initiatives related to medical products.
• Ability to function within a regulatory environment and problem solve to meet challenging demands.
• An understanding of Federal Regulations related to the work of the Center for Biologics Evaluation and Research.
• Prior senior leadership experience and excellent interpersonal skills.
Desired Professional Experience:
• Provides scientific and technical leadership, direction, and supervision to a multidisciplinary scientific, engineering, and medical science staff.
• Provides expert technical and scientific guidance/assessment to senior leadership on complex, precedent setting, and/or controversial issues involving policies related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.
• Knowledge and understanding of the provisions, limitations, and practical applications of FDA issues, policies, laws, and regulations related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.
• Collaborates with other scientific, technical, and regulatory staff to develop and implement policy initiatives related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.
• Ability to communicate complex scientific concepts to a diverse audience (examples include, policy makers, manufacturers, scientists, universities, and the public).
Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.
How to Apply: Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), copy of your unofficial transcripts (if applicable), copy of your active medical license/s (if applicable), copy of your board certification/s (if applicable), SF50 (if applicable), latest signed PMAP (if applicable), and letter of interest with “CURES CBER/OTP Super Office Director” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through May 31, 2023.
Announcement Contact: For questions regarding this Cures position, please contact CBERHumanCapital@fda.hhs.gov.
The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.
FDA is an equal opportunity employer Show more details...
via AARP Job Board
schedule_type: Full-time
This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career- conditional appointment and compensated under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here... https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The
This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career- conditional appointment and compensated under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here... https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective.
The mission of the Center for Biologics Evaluation and Research (CBER) is to protect and enhance the public health through the regulation of biological and related products by ensuring that these products are safe and effective and available to those who need them. Biological products often represent cutting-edge biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have few or no other treatment options.
The Office of Therapeutic Products (OTP) is a newly established Super Office within CBER. The mission of OTP is to is to promote public health through a data-driven process to provide regulatory oversight that helps ensure medical products are safe and effective. OTP oversees development and regulation for a wide variety of products, including cells, tissues, and gene therapies, protein products derived from blood and their recombinant analogues, along with certain medical devices used in the production of these products. In addition to regulatory review of product quality, safety and effectiveness, the Super Office conducts applied scientific research related to the products that it regulates, contributes to the development of relevant regulatory policy, and supports other agency and center components involved in ensuring compliance with agency biologics regulations.
Duties/Responsibilities
As the Super Office Director of OTP in CBER, the incumbent provides executive leadership to the six offices within the Super Office and to the Immediate Office of the Director (IOD) regarding the review of regulatory submissions for quality, safety and effectiveness, for the conduct of applied scientific research and relevant regulatory policy. Manages highly complex and difficult assignments of national and international scope and significance, as well as additional related duties as noted below.
• Oversees the various offices and programs within the Super Office, which involves applying a science-based approach in support of regulatory decision-making regarding clinical applications, the conduct of applied scientific research, and the development of regulatory policy; supports compliance and enforcement activities related to regulated products; collaborates with other Center and Agency units requiring expertise in therapeutic product evaluation.
• Supervises the various Office Directors and the Immediate Office in planning, managing, organizing, and directing regulatory review operations, and research activities of the Super Office as carried out by the Office Directors and highly trained and skilled staff (Immediate Office and support staff).
• Leads, prepares, coordinates, and attends critical sponsor/internal meetings, supports, and promotes leadership, management, and reviewer development.
• Advances new policy initiatives related to regulated products, proposing and developing guidance, changes in regulations, and legislative initiatives, as appropriate, based on the emerging science.
• Directs the implementation of new laws and regulations which affect the mission of the Super Office including initiating and implementing new policies, systems, procedures, and organizational structures.
• Develops and implements Super Office policies and plans, makes critical decisions, and provides expert advice and counsel on cost-effective use of all resources including budget and manpower.
• Oversees the development of core competencies of review staff in the Super Office to maintain and render outstanding regulatory review, advice, policy, and publications and is responsible for identifying new scientific initiatives.
• Applies administrative and program management principles and skills to carry out the mission of the Super Office and addresses and solves challenging and often precedent- setting problems. Seeks and develops the most cost effective and fiscally responsible methods to manage and lead day to day operations.
• Represents the Super Office in dealing and negotiating with individuals representing organizations such as the Congress; other Federal agencies; State, local, and foreign governments; the regulated industry; and professional societies.
• In consultation with the Center Director, initiates and participates fully in discussions and decisions concerning Super Office plans, programs, and activities, both in strategic planning and implementation. Provides authoritative advice and assessments of the impact of actual and proposed Administration or Congressional actions on the program segments, functions, and activities of the division.
• Serves as subject matter expert and is a recognized authority and senior level expert
How to Apply:
Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), copy of your unofficial transcripts (if applicable), copy of your active medical license/s (if applicable), copy of your board certification/s (if applicable), SF50 (if applicable), latest signed PMAP (if applicable), and letter of interest with “CURES CBER/OTP Super Office Director” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through May 31, 2023.
Announcement Contact:
For questions regarding this Cures position, please contact CBERHumanCapital@fda.hhs.gov.
The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.
FDA is an equal opportunity employer Show more details...
Additional information on 21st Century Cures Act can be found here... https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective.
The mission of the Center for Biologics Evaluation and Research (CBER) is to protect and enhance the public health through the regulation of biological and related products by ensuring that these products are safe and effective and available to those who need them. Biological products often represent cutting-edge biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have few or no other treatment options.
The Office of Therapeutic Products (OTP) is a newly established Super Office within CBER. The mission of OTP is to is to promote public health through a data-driven process to provide regulatory oversight that helps ensure medical products are safe and effective. OTP oversees development and regulation for a wide variety of products, including cells, tissues, and gene therapies, protein products derived from blood and their recombinant analogues, along with certain medical devices used in the production of these products. In addition to regulatory review of product quality, safety and effectiveness, the Super Office conducts applied scientific research related to the products that it regulates, contributes to the development of relevant regulatory policy, and supports other agency and center components involved in ensuring compliance with agency biologics regulations.
Duties/Responsibilities
As the Super Office Director of OTP in CBER, the incumbent provides executive leadership to the six offices within the Super Office and to the Immediate Office of the Director (IOD) regarding the review of regulatory submissions for quality, safety and effectiveness, for the conduct of applied scientific research and relevant regulatory policy. Manages highly complex and difficult assignments of national and international scope and significance, as well as additional related duties as noted below.
• Oversees the various offices and programs within the Super Office, which involves applying a science-based approach in support of regulatory decision-making regarding clinical applications, the conduct of applied scientific research, and the development of regulatory policy; supports compliance and enforcement activities related to regulated products; collaborates with other Center and Agency units requiring expertise in therapeutic product evaluation.
• Supervises the various Office Directors and the Immediate Office in planning, managing, organizing, and directing regulatory review operations, and research activities of the Super Office as carried out by the Office Directors and highly trained and skilled staff (Immediate Office and support staff).
• Leads, prepares, coordinates, and attends critical sponsor/internal meetings, supports, and promotes leadership, management, and reviewer development.
• Advances new policy initiatives related to regulated products, proposing and developing guidance, changes in regulations, and legislative initiatives, as appropriate, based on the emerging science.
• Directs the implementation of new laws and regulations which affect the mission of the Super Office including initiating and implementing new policies, systems, procedures, and organizational structures.
• Develops and implements Super Office policies and plans, makes critical decisions, and provides expert advice and counsel on cost-effective use of all resources including budget and manpower.
• Oversees the development of core competencies of review staff in the Super Office to maintain and render outstanding regulatory review, advice, policy, and publications and is responsible for identifying new scientific initiatives.
• Applies administrative and program management principles and skills to carry out the mission of the Super Office and addresses and solves challenging and often precedent- setting problems. Seeks and develops the most cost effective and fiscally responsible methods to manage and lead day to day operations.
• Represents the Super Office in dealing and negotiating with individuals representing organizations such as the Congress; other Federal agencies; State, local, and foreign governments; the regulated industry; and professional societies.
• In consultation with the Center Director, initiates and participates fully in discussions and decisions concerning Super Office plans, programs, and activities, both in strategic planning and implementation. Provides authoritative advice and assessments of the impact of actual and proposed Administration or Congressional actions on the program segments, functions, and activities of the division.
• Serves as subject matter expert and is a recognized authority and senior level expert
How to Apply:
Please submit electronic resume or curriculum vitae (please be sure to clearly define the number of years using month and year training completed, in addition to describing duties performed during that time period), copy of your unofficial transcripts (if applicable), copy of your active medical license/s (if applicable), copy of your board certification/s (if applicable), SF50 (if applicable), latest signed PMAP (if applicable), and letter of interest with “CURES CBER/OTP Super Office Director” in the subject line to: CBERHumanCapital@fda.hhs.gov. Applications will be accepted through May 31, 2023.
Announcement Contact:
For questions regarding this Cures position, please contact CBERHumanCapital@fda.hhs.gov.
The Department of Health and Human Services is an equal opportunity employer with a smoke-free environment.
FDA is an equal opportunity employer Show more details...
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