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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...
via RAPS Career Connections
posted_at: 6 days agoschedule_type: Full-timesalary: 213,491 a year
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 be paid 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
To view 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 be paid 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
To view the full vacancy announcement, click here: https://www.fda.gov/media/167425/download
Introduction
The Food and Drug Administration (FDA) 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 safe, and effective.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over the counter and prescription drugs, including biological therapeutics and generic drugs.
The mission of the Office of Compliance (OC) is to shield the public from poor-quality, unsafe, and ineffective drugs through proactive compliance strategies and risk-based enforcement actions. CDER Compliance strives to be a model of efficiency, innovation, and organizational excellence. CDER Compliance makes strategic and risk-based decisions that are guided by law and science to communicate clearly with stakeholders, foster global collaboration, promote voluntary compliance, and take decisive action.
Duties/Responsibilities
As the Deputy Super Office Director (Supervisory Regulatory Counsel) , reporting to the Deputy Director of the Office of Compliance (CDER OC), the incumbent will share the responsibility for the management and direction of a multi-disciplinary staff of more than 400 scientific and regulatory professionals engaged in planning, executing, and administering a broad range of national programs related to protecting the health of patients and consumers from risks associated with violations of federal drug law and regulation.
• Responsible for the development and implementation of proactive and risk-based compliance and enforcement strategies and actions that are patient-focused and risk-based to secure the safety, efficacy, and quality of the nation’s drug supply.
• Strategically oversees and implements FDA and Center compliance programs and projects to identify, assess, and prioritize the public health significance of legal violations presented throughout the drug lifecycle. Develops and implements innovative enforcement strategies and risk-based decision-making to reduce public health risk by ensuring that marketed drugs are of high quality and integrity, properly labeled, safe, pure, and meet applicable drug approval requirements.
• Develops comprehensive policy and procedural guidelines for handling legal actions related to human drugs. Reviews and approves legal approaches and actions in cases, particularly those that are controversial, precedent setting, or otherwise significant cases.
• Represents the Director/Office in meetings, discussions, and conferences with senior Agency and Departmental officials, regulated industry representatives, the medical, scientific, and academic communities, national and international scientific and health related professional organizations, Congress, and representatives from other Federal, state, local and international governmental agencies to present and explain Office activities, actions, plans, and policies.
• Serves as the lead on special projects and activities of interest and concern to the Office Director that involve sensitive and controversial problems, issues, or actions related to policy and/or program matters which may result from a public health emergency or may have congressional interest.
Supervisory Responsibilities:
Manages one or more portfolios and provides leadership and direction for multiple, smaller program offices in coordination with the Super Office Director. Directly supervises the Super Office’s Senior Medical Officer and Senior Program Manager. Shares responsibility with the Super Office Director to provide overall program direction to subordinate Sub-Offices and Divisions and through the responsible managers of these Offices and Divisions. Provides direction to a budgeted staff of 436 employees including scientific, medical, legal, professional, technical, administrative, and clerical personnel ranging in pay scale from Titles 42 and GS 15 Supervisory positions to entry levels, as well as scientists and physicians hired under Title 42 and Title 38.
How to Apply
All qualified candidates should submit their resume with cover letter and transcripts in PDF format by May 5, 2023, to: FDACDEROC_Recruit@fda.hhs.gov. Candidate resumes may be shared with hiring officials within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share.”
For questions, please submit your inquiry with email subject title “CDER-OC-Deputy Super Office Director” when applying or submitting questions.
Announcement Contact
For questions regarding this Cures position, please contact FDACDEROC_Recruit@fda.hhs.gov.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.
Degree: A juris doctorate degree from an accredited institution of higher learning 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
To view the full vacancy announcement, click here: https://www.fda.gov/media/167425/download
Introduction
The Food and Drug Administration (FDA) 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 safe, and effective.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over the counter and prescription drugs, including biological therapeutics and generic drugs.
The mission of the Office of Compliance (OC) is to shield the public from poor-quality, unsafe, and ineffective drugs through proactive compliance strategies and risk-based enforcement actions. CDER Compliance strives to be a model of efficiency, innovation, and organizational excellence. CDER Compliance makes strategic and risk-based decisions that are guided by law and science to communicate clearly with stakeholders, foster global collaboration, promote voluntary compliance, and take decisive action.
Duties/Responsibilities
As the Deputy Super Office Director (Supervisory Regulatory Counsel) , reporting to the Deputy Director of the Office of Compliance (CDER OC), the incumbent will share the responsibility for the management and direction of a multi-disciplinary staff of more than 400 scientific and regulatory professionals engaged in planning, executing, and administering a broad range of national programs related to protecting the health of patients and consumers from risks associated with violations of federal drug law and regulation.
• Responsible for the development and implementation of proactive and risk-based compliance and enforcement strategies and actions that are patient-focused and risk-based to secure the safety, efficacy, and quality of the nation’s drug supply.
• Strategically oversees and implements FDA and Center compliance programs and projects to identify, assess, and prioritize the public health significance of legal violations presented throughout the drug lifecycle. Develops and implements innovative enforcement strategies and risk-based decision-making to reduce public health risk by ensuring that marketed drugs are of high quality and integrity, properly labeled, safe, pure, and meet applicable drug approval requirements.
• Develops comprehensive policy and procedural guidelines for handling legal actions related to human drugs. Reviews and approves legal approaches and actions in cases, particularly those that are controversial, precedent setting, or otherwise significant cases.
• Represents the Director/Office in meetings, discussions, and conferences with senior Agency and Departmental officials, regulated industry representatives, the medical, scientific, and academic communities, national and international scientific and health related professional organizations, Congress, and representatives from other Federal, state, local and international governmental agencies to present and explain Office activities, actions, plans, and policies.
• Serves as the lead on special projects and activities of interest and concern to the Office Director that involve sensitive and controversial problems, issues, or actions related to policy and/or program matters which may result from a public health emergency or may have congressional interest.
Supervisory Responsibilities:
Manages one or more portfolios and provides leadership and direction for multiple, smaller program offices in coordination with the Super Office Director. Directly supervises the Super Office’s Senior Medical Officer and Senior Program Manager. Shares responsibility with the Super Office Director to provide overall program direction to subordinate Sub-Offices and Divisions and through the responsible managers of these Offices and Divisions. Provides direction to a budgeted staff of 436 employees including scientific, medical, legal, professional, technical, administrative, and clerical personnel ranging in pay scale from Titles 42 and GS 15 Supervisory positions to entry levels, as well as scientists and physicians hired under Title 42 and Title 38.
How to Apply
All qualified candidates should submit their resume with cover letter and transcripts in PDF format by May 5, 2023, to: FDACDEROC_Recruit@fda.hhs.gov. Candidate resumes may be shared with hiring officials within CDER with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share.”
For questions, please submit your inquiry with email subject title “CDER-OC-Deputy Super Office Director” when applying or submitting questions.
Announcement Contact
For questions regarding this Cures position, please contact FDACDEROC_Recruit@fda.hhs.gov.
The U.S. Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.
Degree: A juris doctorate degree from an accredited institution of higher learning Show more details...
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