B08.04 - Attachment 04 - Labor Categories and Descriptions.pdf

Attachment 04

HISTORICAL LABOR CATEGORIES AND DESCRIPTIONS

USAMRIID Scientific, Technical and Project Management Support Services

Labor categories and descriptions are provided only as historical data. Please note that this historical data is only put in place for Offerors to ascertain the approximate or estimated level of effort for all tasks contained in this award.

However, this is not to be construed as either mandatory or necessarily the best approach. It is only in place as a reference to allow Offerors to better understand the general scope of this effort from the Government’s perspective.

Offerors are not bound to propose these labor categories or quantities, rather offerors are expected to provide its best solution citing the labor mix and quantity required to accomplish all tasks. If offerors have determined the following historical data provided isn’t the best technical solution to ensure completion of performance-based acquisition, offerors are strongly encouraged and expected to submit the appropriate labor mix consistent with all the cost/price and non-cost/price aspects of its approach.

Educational, License, and Certification Requirements

At Contract award, Contractor personnel including subcontractors and consultants in the below stated positions must (1) possess and maintain the appropriate licensure and certification and (2) be in good standing and under no restrictions with the state licensure board in any state in which a license is held or has been held. The Contractor personnel must be current with and have completed all continuing education requirements specified by their professional licensure or certification. Contractor personnel assigned to the below positions shall provide proof of the required education, licensure, and certification as applicable.

The following labor categories were designated as key personnel:

Computational Biologist 2, 3 and 4 Licensed Nurse 2 Physician 3, 4 and 5 Trainer IV Subject Matter Expert Scientists 2, 3, 4 and 5

Labor Categories marked with (**) were Key Personnel

Labor Categories and Descriptions

Biostatistician 2. Provides statistical guidance and provides recommendations for study design and statistical analysis. Writes or reviews statistical section of protocols, prepares analysis plans, and writes detailed specifications for analysis files, consistency checks, tables, and figures. Interprets analyses and writes statistical sections of study reports. Communicates with data managers, study personnel, and other clients regarding statistical design, programming, and analysis. Develops and updates appropriate statistical documentation, stores documents and data, and performs all functions in accordance with applicable regulations, guidance, and procedures. Familiar with a variety of the field's concepts, regulations, standards, practices, and procedures. Works semi-independently to perform the functions of the job, using knowledge, experience, professional judgment, and input of project and organizational leaders to plan and accomplish goals.

Biostatistician 3. Provides statistical guidance and develops strategies and recommendations for study design and statistical analysis. Writes or reviews statistical section of protocols, prepares analysis plans, and writes detailed specifications for analysis files, consistency checks, tables, and figures. Interprets analyses and writes statistical sections of study reports. Communicates with data managers, study personnel, and other clients regarding statistical design, programming, and analysis. Assures that plans and execution of statistical functions meet all applicable regulations, guidance, and procedures. Develops and updates appropriate statistical documentation, and stores documents and data in accordance with applicable regulations and procedures. Establishes, maintains, and recommends updates to policies and procedures such as documentation of standard operating procedures.

Experienced and skilled with a wide variety of the field's concepts, regulations, standards, practices, and procedures.

Works independently and relies on extensive knowledge, experience, and judgment to plan and accomplish goals.

Clinical Data Manager 2. Involved in all aspects of clinical data management. Performs database development in conjunction with staff and clients and assures databases and processes meet appropriate regulations and standards.

Manages the gathering, cleaning, extraction, transfer, and reporting of clinical data, interfacing with appropriate personnel and providing support throughout the data management process. Develops and updates appropriate data management documentation, and stores documents and data in accordance with applicable regulations and procedures. Establishes, maintains, and recommends updates to policies and procedures such as documentation of standard operating procedures. Desired familiarity with a variety of the field’s concepts, regulations, standards, practices, and procedures.

Clinical Data Manager 3. Responsible for all aspects of clinical data management. Performs database development in conjunction with staff and clients and assures databases and processes meet appropriate regulations and standards.

Manages the gathering, cleaning, extraction, transfer, and reporting of clinical data, interfacing with appropriate personnel and providing support throughout the data management process. Develops and updates appropriate data management documentation, and stores documents and data in accordance with applicable regulations and procedures. Establishes, maintains, updates, and standardizes policies and procedures such as documentation of standard operating procedures. Desired experience and skill with a wide variety of the field’s concepts, regulations, standards, practices, and procedures.

Clinical Research Associate 1. Advises principal investigator and support staff in administration and execution of clinical protocols. Monitors clinical studies to assure compliance with applicable Department of Defense, national, and international laws and regulations, and to ensure that the safety and privacy of subjects are protected. Ensures compliance with protocol and overall clinical objectives and verifies investigational product accountability.

Acquires, analyzes and evaluates clinical data gathered during research and assures accurate and complete documentation of patient care and protocol execution. Desired experience in source data verification with case report forms. Assists in preparing reports and regulatory files submissions. Knowledgeable in the areas of clinical research and regulatory affairs as related to clinical studies, healthcare management, and technology-based training and education programs.

Clinical Research Associate 2. Advises principal investigator and support staff in design, administration, and execution of clinical protocols. Monitors clinical studies to assure compliance with applicable Department of Defense, national, and international laws and regulations, and to ensure that the safety and privacy of subjects are protected. Ensures compliance with protocol and overall clinical objectives and verifies investigational product accountability. Acquires, analyzes and evaluates clinical data gathered during research and assures accurate and complete documentation of patient care and protocol execution. Desired experience in source data verification with case report forms. Completes reports and ensures management and resolution of all findings. Assists in preparing regulatory files submissions. Knowledgeable in the areas of clinical research and regulatory affairs as related to clinical studies, healthcare management, and technology-based training and education programs.

Clinical Research Associate 3. Advises principal investigator, nursing staff, and support staff in design, administration, and execution of clinical protocols. Monitors clinical studies to assure compliance with applicable Department of Defense, national, and international laws and regulations, and to ensure that the safety and privacy of subjects are protected. Ensures compliance with protocol and overall clinical objectives and verifies investigational product accountability. Acquires, analyzes and evaluates clinical data gathered during research and assures accurate and complete documentation of patient care and protocol execution. Desired experience in source data verification with case report forms. Completes reports and ensures management and resolution of all findings. Assists in preparing regulatory files and submissions. Desired knowledge and experience in the areas of clinical research and regulatory affairs as related to clinical studies, healthcare management, and technology-based training and education programs. May provide training and guidance to others, in coordination with division supervisors or Investigators.

Clinical Veterinarian 2. Provides clinical medicine services for laboratory animals in a research environment.

Provides veterinary animal care and research support; provides guidance, training and consultation in all aspects of regulatory animal medicine and science to research and support staff; and ensures appropriate delivery of husbandry practices. Performs routine physical examinations, evaluations, diagnosis and treatment of illnesses or injuries.

Performs clinical and surgical procedures on animals. Performs/assists with imaging procedures such as radiography and ultrasound. Assists with research protocol development, execution and refinements. Must have veterinary medicine degree and appropriate license to practice veterinary medicine as required by Public Law 99-158, Animal Welfare Act and Animal Welfare Regulations, State of Maryland regulations and agricultural code, and all other appropriate federal, state, or local laws and regulations. Must have appropriate education, training, and experience to assure that the facility retains Association for the Assessment and Accreditation of Laboratory Animal Care (AALAC) accreditation in accordance with AR 40-33 and DoDI 3216.0.

Clinical Veterinarian 3. Provides clinical medicine services for laboratory animals in a research environment.

Provides veterinary animal care and research support; provides guidance, training and consultation in all aspects of regulatory animal medicine and science to research and support staff; and ensures appropriate delivery of husbandry practices. Performs routine physical examinations, evaluations, diagnosis and treatment of illnesses or injuries.

Performs clinical and surgical procedures on animals. Performs/assists with imaging procedures such as radiography and ultrasound. Must have veterinary medicine degree and appropriate license to practice veterinary medicine as required by Public Law 99-158, Animal Welfare Act and Animal Welfare Regulations, State of Maryland regulations and agricultural code, and all other appropriate federal, state, or local laws and regulations. Must have appropriate education, training, and experience to assure that the facility retains Association for the Assessment and Accreditation of Laboratory Animal Care (AALAC) accreditation in accordance with AR 40-33 and DoDI 3216.0. .

Clinical Veterinarian 4. Provides clinical medicine services for laboratory animals in a research environment.

Provides veterinary animal care and research support; provides guidance, training and consultation in all aspects of regulatory animal medicine and science to research and support staff; and ensures appropriate delivery of husbandry practices. Performs routine physical examinations, evaluations, diagnosis and treatment of illnesses or injuries.

Performs clinical and surgical procedures on animals. Performs/assists with imaging procedures such as radiography and ultrasound. Assists with the management of the Institutional Animal Care and Use Program. Must have veterinary medicine degree and appropriate license to practice veterinary medicine as required by Public Law 99- 158, Animal Welfare Act and Animal Welfare Regulations, State of Maryland regulations and agricultural code, and all other appropriate federal, state, or local laws and regulations. Must have appropriate education, training, and experience to assure that the facility retains Association for the Assessment and Accreditation of Laboratory Animal Care (AALAC) accreditation in accordance with AR 40-33 and DoDI 3216.0.

Computational Biologist 1. Provides computational and analytical tool development services, comprising the ability to construct high-throughput analysis pipelines for omics data and integrates with in-house databases. Has background in bioinformatics and adept in –omics data management. Performs work with scripting languages (Perl, Pyton, R, etc.), manages large –omics data sets, works with databases (Oracle, MySQL, etc.) and transport data between systems. Assists in running analytical workflows for standard –omics data sets. Assist in developing analytical pipelines code, open source tools installations and maintenance. Maintains laboratory records documenting sample processing log and data entry for Laboratory Information Management Systems (LIMS).

Reviews Standard Operating Procedures and workflows in accordance with applicable policies. Has basic knowledge of bioinformatics programming design, modification and implementation, open source application and data security concepts and methods, and an understanding of relational databases and operating systems. Preferred experience/knowledge with Linux/UNIX environment, knowledge in programming language (Java, C++), experience in proteomics, genomics and/or high content imaging, and working ability of next generation sequencing open source tools (BLAST, STAR, TopHat, CuffLinks, BWA, GATK, etc.). Must have bachelor degree in biomedical science, bioinformatics, math, computer science or related field.

Computational Biologist 2**. Provides laboratory and scientific support to perform computational and analytical tool development, comprising the ability to construct high-throughput analysis pipelines for multiomics data, and to integrate with in-house databases. Possess strong background in bioinformatics and adept in multiomics data management. Works with scripting languages (Perl, Python, R, etc.), programming languages (Java, C++), manages large –omics data sets (genomics, proteomics, etc.), works with databases (Oracle, MySQL, etc.) and transports data between systems. Runs analytical workflows for standard –omics data sets. Maintains analytical pipelines code, open source tools installations and maintenance. Works with both technical and non-technical personnel in multiple fields of expertise. Reviews Standard Operating Procedures and workflows in accordance with applicable policies.

Must have knowledge of bioinformatics programming design, modification and implantation, knowledge of open source application and data security concepts and methods. May have experience in Proteomics, Genomics, High Content Imaging and academic research environment. Preferred ability to use next generation sequencing open source tools such as BLAST, STAR, TopHat, CuffLinks, BWA, GATK and other multiomics applications.

Experience and knowledge with Linux/UNIX environment is required. Must possess Master’s Degree or BA/BS plus 2 years’ experience in biomedical science, bioinformatics, math, computer science or a related field.

Computational Biologist 3**. Provides laboratory and scientific support to perform computational and analytical tool development, comprising the ability to construct high-throughput analysis pipelines for multiomics data, and to integrate with in-house databases, adept in analyzing downstream data analysis. Must possess strong background in bioinformatics and adept in multiomics data management. Will use extensive programming knowledge to work with scripting languages (Perl, Python, R, etc.), programming languages (Java, C++), manage large –omics data sets (genomics, proteomics, etc.), work with databases (Oracle, MySQL, etc.) and transport data between systems. Runs analytical workflows for standard –omics data sets. Maintains analytical pipelines code, open source tools installations and maintenance. Works with both technical and non-technical personnel in multiple fields of expertise.

Generates monthly lab reports and contributes to manuscript publications. Ensures Standard Operating Procedures and workflows are followed, tracked and documented in accordance with applicable policies. Must have knowledge of bioinformatics programming design, modification and implantation, knowledge of open source application and data security concepts and methods, understanding of relational databases and operating systems in addition to an understanding of statistical/machine learning concepts and operating systems. Experience and knowledge with Linux/UNIX environment and next generation sequencing open source tools such as BLAST, STAR, TopHat, CuffLinks, BWA, GATK is required. Must possess a PhD, Master’s degree plus 4 year’ experience or BA/BS degree plus 6 years’ experience in biomedical science, bioinformatics, math, computer science or a related field.

Computational Biologist 4**. Provides laboratory and scientific support to perform computational and analytical tool development, comprising the ability to construct high-throughput analysis pipelines for multiomics data, and to integrate with in-house databases, adept in analyzing downstream data analysis. Must possess strong background in bioinformatics, statistical analysis/machine learning/deep learning concepts and adept in multiomics data management. Will use extensive knowledge to work with scripting languages (Perl, Python, R, etc.), programming languages (Java, C++), manage large –omics data sets (genomics, proteomics, etc.), work with databases (Oracle, MySQL, etc.) and transport data between systems. Runs analytical workflows for standard –omics data sets.

Maintains analytical pipelines code, open source tools installations and maintenance. Works with both technical and non-technical personnel in multiple fields of expertise. Generates monthly lab reports and is lead author for manuscript publications. Ensures Standard Operating Procedures and workflows are followed, tracked and documented in accordance with applicable policies. Must have knowledge of bioinformatics programming design, modification and implantation, knowledge of open source application and data security concepts and methods, understanding of relational databases and operating systems in addition to an understanding of statistical/machine learning concepts and operating systems. Will have experience in Proteomics, Genomics and High Content Imaging.

Experience and knowledge with Linux/UNIX environment and next generation sequencing open source tools such as BLAST, STAR, TopHat, CuffLinks, BWA, GATK is required. Must possess PhD plus 3 years of experience, a Master’s Degree with 6 years’ experience or BA/BS with 10 years’ experience in biomedical science, bioinformatics, math, computer science or a related field. Experience demonstrates small team leadership on bioinformatics software development.

Laboratory Technician 1. Performs laboratory procedures, testing, research activities, and other scientific and administrative tasks in fields such as biochemistry, immunology, microbiology, virology, bacteriology, molecular or cell biology, veterinary medicine, toxicology, or other scientific discipline. Desires knowledge of commonly-used concepts, practices, and procedures within the particular field. Relies on instructions and pre-established guidelines to perform the functions of the job, including but not limited to relevant Standard Operating Procedures, national standards of research technical accuracy, and/or other written guidelines provided. Reads, understands, and executes techniques and procedures within the quality standards and timelines prescribed by the research plan. Records all laboratory procedures, research project data, and results in accordance with applicable regulations and procedures.

Laboratory Technician 2. Performs laboratory procedures, testing, research activities, and other scientific and administrative tasks in fields such as biochemistry, immunology, microbiology, virology, bacteriology, molecular or cell biology, veterinary medicine, toxicology, or other scientific discipline. Desires familiarity with standard concepts, practices, and procedures within the particular field. Follows instructions and guidelines to perform the functions of the job, including but not limited to relevant Standard Operating Procedures, national standards of research technical accuracy, and/or other written guidelines provided. Assists in planning and accomplishing goals.

Reads, understands, and executes techniques and procedures within the quality standards and timelines prescribed by the research plan. Records all laboratory procedures and research project data, data analyses, and analytical conclusions of analyses in accordance with applicable regulations and procedures. Typically requires 1-3 years of related experience or may need 0 years of experience with additional specialized training and/or certification.

Laboratory Technician 3. Performs laboratory procedures, testing, research activities, and other tasks in fields such as biochemistry, immunology, microbiology, virology, bacteriology, molecular or cell biology, veterinary medicine, toxicology, or other scientific discipline. Possesses experience with a variety of the field's concepts, practices, and procedures. Follows instructions and guidelines to perform the functions of the job, including but not limited to relevant Standard Operating Procedures, national standards of research technical accuracy, and/or other written guidelines provided. Plans and accomplish goals, participates in development of research work plans, proposals, budgets, and agreements. Reads, understands, and executes techniques and procedures within the quality standards and timelines prescribed by the research plan. Records all laboratory procedures and research project data, data analyses, and analytical conclusions of analyses in accordance with applicable regulations and procedures. Performs a variety of scientific and administrative tasks, with a certain degree of creativity and latitude expected. Typically requires 3-5 years of related experience or may need 2 years’ experience with additional specialized training and/or certification.

Laboratory Technician 4. Performs laboratory procedures, testing, research activities, and other tasks in fields such as aerobiology, biochemistry, immunology, microbiology, virology, bacteriology, molecular or cell biology, veterinary medicine, toxicology, or other scientific discipline. Possesses experience with a variety of the field's concepts, practices, and procedures. Follows instructions and guidelines to perform the functions of the job, including but not limited to relevant Standard Operating Procedures, national standards of research technical accuracy, and/or other written guidelines provided. Plans and accomplish goals, participates in development of research work plans, proposals, budgets, and agreements. Independently, or with little assistance, reads, understands, and executes techniques and procedures within the quality standards and timelines prescribed by the research plan. Records all laboratory procedures and research project data, data analyses, and analytical conclusions of analyses in accordance with applicable regulations and procedures. Performs a variety of scientific and administrative tasks. May provide training and mentorship to junior staff. Specialized skills may be required, including but not limited to, aerobiology, clinical pathology, electron or confocal microscopy, histopathology, quality assurance, and good laboratory practice. May participate in support of laboratory biosafety requirements and laboratory space management, in coordination with director, Investigators, or other relevant staff. Typically requires a bachelor’s degree and 5-7 years of related experience.

Laboratory Technician 5**. Performs laboratory procedures, testing, research activities, and other tasks in fields such as aerobiology, biochemistry, immunology, microbiology, virology, bacteriology, molecular or cell biology, veterinary medicine, toxicology, or other scientific discipline. Possesses experience, skill and expertise with a large variety of the field's concepts, practices, and procedures. Plans and accomplish goals, participates in or leading development of research work plans, proposals, budgets, and agreements. May function as a study Lead Investigator. Independently reads, understands, and executes techniques, procedures, and plans to meet requirements of quality standards, national standards of research technical accuracy, other relevant written guidelines, and timelines prescribed by the research plan and based on professional judgment. Records all laboratory procedures and research project data, data analyses, and analytical conclusions of analyses in accordance with applicable regulations and procedures. Performs a variety of scientific and administrative tasks. Provides training and mentorship to junior staff. Specialized skills may be required, including but not limited to, aerobiology, clinical pathology, electron or confocal microscopy, histopathology, quality assurance, and good laboratory practice. May participate in support of laboratory biosafety requirements and laboratory space management, in coordination with director, Investigators, or other relevant staff. Typically requires a bachelor’s degree with 7+ years of related experience or a master’s degree and 3+ years of related experience.

Licensed Nurse 1. Provides support of research protocols. Records all laboratory procedures and research project data, data analyses and analytical conclusions of analyses. Desires knowledge in the areas of research licensed practical nursing and regulatory affairs as related to clinical studies, healthcare management, and technology based training and education programs. Must have completed a state approved educational program and have taken and passed the National Council Licensure Examination for Licensed Practical Nurse. Desires experience with applying federal, state, departmental and institutional nursing procedures.

Licensed Nurse 2**. Provides support of research protocols, including Good Clinical Practice and FDA-regulated clinical trials. Records all laboratory procedures and research project data, data analyses and analytical conclusions of analyses. Desires knowledge in the areas of research licensed nursing, regulatory affairs, and clinical safety as related to clinical studies, healthcare management, and technology-based training and education programs. Must have completed a state approved educational program and have taken and passed the National Council Licensure Examination for Licensed Practical Nurse. Desires experience with federal, state, departmental and institutional nursing procedures to planned and ongoing studies. Performs a variety of complicated tasks. Performs duties and responsibilities independently based on broad guidelines and objectives.

Physician 1. Provide professional services to include performing clinical and research protocols, performing clinical trials in accordance with FDA’s investigational new drug and other regulations, and appropriately documenting research data to support studies. Acquires, analyzes and evaluates clinical data gathered during research and assures accurate and complete documentation of patient care and protocol execution. Provides support to FDA-regulated studies as Associate Investigator, performing roles as delegated by the Principal Investigator, and assuring the safety and privacy of human subjects. Desires knowledge and understanding of relevant Department of Defense, national, and international laws, regulations, and guidance; and application of these to research studies as appropriate. Must have taken and passed the U.S. Medical Licensing Examination and/or the Comprehensive Osteopathic Medical Licensing Examination and meet any additional federal, state, and local requirements. Desires experience in clinical care or clinical research

Physician 2. Provide professional services to include performing clinical and research protocols, performing clinical trials in accordance with FDA’s investigational new drug and other regulations, and appropriately documenting research data to support studies. Acquires, analyzes and evaluates clinical data gathered during research and assures accurate and complete documentation of patient care and protocol execution. Provides support to FDA-regulated studies as Associate Investigator, performing roles as delegated by the Principal Investigator, and assuring the safety and privacy of human subjects. Desires knowledge and understanding of relevant Department of Defense, national, and international laws, regulations, and guidance; and application of these to research studies as appropriate. Must have taken and passed the U.S. Medical Licensing Examination and/or the Comprehensive Osteopathic Medical Licensing Examination and meet any additional federal, state, and local requirements. Desires experience with clinical care or clinical research and GCP clinical studies.

Physician 3**. Provide professional services to include performing clinical and research protocols, performing clinical trials in accordance with FDA’s investigational new drug and other regulations, and appropriately documenting research data to support studies. Acquires, analyzes and evaluates clinical data gathered during research and assures accurate and complete documentation of patient care and protocol execution. Provides support to FDA-regulated studies as Principal or Associate Investigator, and assuring the safety and privacy of human subjects. Desires knowledge and understanding of relevant Department of Defense, national, and international laws, regulations, and guidance; and application of these to research studies as appropriate. Must have taken and passed the U.S. Medical Licensing Examination and/or the Comprehensive Osteopathic Medical Licensing Examination and meet any additional federal, state, and local requirements. Desires experience with clinical care or clinical research and knowledgeable of the duties and responsibilities of an Associate or Principal Investigator for GCP clinical studies.

Physician 4**. Provide professional services to include performing clinical and research protocols, performing clinical trials in accordance with FDA’s investigational new drug and other regulations, and appropriately documenting research data to support studies. Acquires, analyzes and evaluates clinical data gathered during research and assures accurate and complete documentation of patient care and protocol execution. Provides support to FDA-regulated studies as Principal or Associate Investigator, and assuring the safety and privacy of human subjects. Performs a variety of complicated tasks, relying on experience and judgment to plan and accomplish goals.

May provide training and guidance to others, in coordination with division supervisors. Desires knowledge and understanding of relevant Department of Defense, national, and international laws, regulations, and guidance; and application of these to research studies as appropriate. Must have taken and passed the U.S. Medical Licensing Examination and/or the Comprehensive Osteopathic Medical Licensing Examination and meet any additional federal, state, and local requirements. Desires experience in clinical care or clinical research and knowledgeable of the duties and responsibilities of an Associate or Principal Investigator for GCP clinical studies.

Physician 5**. Provide professional services to include performing clinical and research protocols, performing clinical trials in accordance with FDA’s investigational new drug and other regulations, and appropriately documenting research data to support studies. Acquires, analyzes and evaluates clinical data gathered during research and assures accurate and complete documentation of patient care and protocol execution. Provides support to FDA-regulated studies as Principal or Associate Investigator, and assuring the safety and privacy of human subjects. Performs a variety of complicated tasks. May provide training and guidance to others, in coordination with division supervisors. Desires knowledge and understanding of relevant Department of Defense, national, and international laws, regulations, and guidance; and application of these to research studies as appropriate. Must have taken and passed the U.S. Medical Licensing Examination and/or the Comprehensive Osteopathic Medical Licensing Examination and meet any additional federal, state, and local requirements. Desires experience with clinical care or clinical research and as an Associate or Principal Investigator for GCP clinical studies. Desires experience with duties and responsibilities of a Principal Investigator of GCP clinical studies.

Program Management Analyst 1. Provides project and portfolio management support for the organization. Desires proficiency in Microsoft Office applications including the ability to prepare and maintain spreadsheets. Ability to organize, query and maintain technical, budget, programmatic and administrative information in an information management system. Coordinates and consolidates progress reports for customers, stakeholders and organization leaders. Creates and supports the development of project schedules and budgets. Generates reports to facilitate project and portfolio planning and guide programmatic decisions. Duties may also include performing a variety of support services such as visitor access control, ordering and receiving office supplies and equipment, preparing meeting minutes, scheduling meetings and preparing, editing or maintaining technical, budget, programmatic and administrative documentation. Requires frequent interactions with internal and external customers and stakeholders.

Must work effectively in a team environment. Relies on instructions and pre-established guidelines to perform the functions of the job.

Program Management Analyst 2. Provides project and portfolio management support for the organization. Desires proficiency in Microsoft Office applications including the ability to prepare and maintain spreadsheets. Ability to organize, query and maintain technical, budget, programmatic and administrative information in an information management system. Coordinates and consolidates progress reports for customers, stakeholders and organization leaders. Creates and supports the development of project schedules and budgets. Creates reports to facilitate project and portfolio planning and guide programmatic decisions. Duties may also include performing a variety of support services such as visitor access control, ordering and receiving office supplies and equipment, preparing meeting minutes, scheduling meetings and preparing, editing or maintaining technical, budget, programmatic and administrative documentation. Requires frequent interactions with internal and external customers and stakeholders.

Must work effectively in a team environment.

Program Management Analyst 3. Provides project and portfolio management support for the organization. Desires proficiency in Microsoft Office applications including the ability to prepare and maintain spreadsheets. Ability to organize, query and maintain technical, budget, programmatic and administrative information in an information management system. Coordinates and consolidates progress reports for customers, stakeholders and organization leaders. Creates and supports the development of project schedules and budgets. Creates and analyzes a wide variety of reports to facilitate project and portfolio planning and guide programmatic decisions. Duties may also include performing a variety of support services such as visitor access control, ordering and receiving office supplies and equipment, preparing meeting minutes, scheduling meetings and preparing, editing or maintaining technical, budget, programmatic and administrative documentation. Requires frequent interactions with internal and external customers and stakeholders. Must work effectively in a team environment. Performs a variety of complicated tasks and must have good analytical skills.

Program Manager 1. Provides scientific and program management skills to support research and development activities for a complex program seeking medical countermeasures for biological defense. Desires experience in both scientific and program management fields. Uses appropriate scientific and program management principles and standards, and knowledge of medical product development, to integrate multiple product research and development efforts. Tracks and monitors the utilization of resources in developing, executing, and attaining program goals. Ability to organize and support work, coordinate efforts with other functions, and support personnel to achieve objectives. Assists in the coordination and supports the work of others. Desires leadership, interpersonal, written and oral communication skills, and the ability to work effectively in a team environment.

Program Manager 2. Provides scientific and program management skills to support research and development activities for a complex program seeking medical countermeasures for biological defense. Desires experience in both scientific and program management fields. Uses appropriate scientific and program management principles and standards, and knowledge of medical product development, to integrate multiple product research and development efforts. Tracks and monitors the utilization of resources in developing, executing, and attaining program goals.

Ability to organize and support work, coordinate efforts with other functions, and support personnel to achieve objectives. Assists in the coordination and supports the work of others. Desires leadership, interpersonal, written and oral communication skills, and the ability to work effectively in a team environment.

Program Manager 3. Provides scientific and program management skills to support research and development activities for a complex program seeking medical countermeasures for biological defense. Desires experience in both scientific and program management fields. Uses appropriate scientific and program management principles and standards, and knowledge of medical product development, to integrate multiple product research and development efforts. Tracks and monitors the utilization of resources in developing, executing, and attaining program goals. Ability to organize and support work, coordinate efforts with other functions, and support personnel to achieve objectives. Coordinates and supports the work of others. Desires leadership, interpersonal, written and oral communication skills, and the ability to work effectively in a team environment.

Project Manager 1. Responsible for the organization, coordination, and completion of projects. Oversees all aspects of assigned projects. Sets deadlines, tracks responsibilities, and monitors project progress in terms of cost, schedule, performance, and risk. Prepares reports for upper management regarding status of project. Desires familiarity with the standard concepts, practices, and procedures within the particular scientific or technical field being managed as well as demonstrating proven experience in project management. Plans and accomplish goals, and assure the successful and timely completion of assigned projects. Performs a variety of tasks. Works under general technical direction, engaging with leaders as needed to solve problems. Desires initiative, interpersonal, written and oral communication skills, and the ability to work effectively in a team environment.

Project Manager 2. Responsible for the organization, coordination, and completion of projects. Oversees all aspects of projects. Sets deadlines, tracks responsibilities, and monitors project progress in terms of cost, schedule, performance, and risk. Prepares reports for upper management regarding status of project. Desires familiarity with a variety of the concepts, practices, and procedures within the particular scientific or technical field being managed as well as demonstrating proven experience in project management. Desires use of experience and judgment in project management and the technical area being managed to plan and accomplish goals and assure the successful and timely completion of projects, coordinating input and work of cross-functional teams as needed. Performs a variety of tasks. Provides support to others and may mentor and provide project management training to junior project managers. Desires leadership, initiative, interpersonal, written and oral communication skills, and the ability to work effectively in a team environment.

Project Manager 3. Responsible for the coordination and completion of projects. Oversees all aspects of projects.

Sets deadlines, tracks responsibilities, and monitors project progress in terms of cost, schedule, performance, and risk. Prepares reports for upper management regarding status of project. Desires familiarity with a variety of the concepts, practices, and procedures within the particular scientific or technical field being managed as well as demonstrating proven experience in project management. Plan and accomplish goals and assure the successful and timely completion of projects, coordinating input and work of cross-functional teams as needed. Performs a variety of tasks. Provides support to others and mentors and provide project management training to junior project managers. Desires leadership, initiative, interpersonal, written and oral communication skills, and the ability to work effectively in a team environment.

Scientist 1. The contractor shall be knowledgeable in a relevant field of the life sciences. The contractor shall have demonstrated their potential ability to independently plan, execute, analyze, and report on their research through their graduate dissertation. The contractor will be expected to execute their assigned tasks, and to share their findings with other members of the project team. Possesses good written and oral communication skills. The Contractor is expected to write reports and publications, and present their findings in meetings.

Scientist 2**. The contractor shall be knowledgeable in a relevant field of the life sciences and have desired experience working in a research laboratory. The contractor shall have demonstrated their subject matter expertise in at least one area, and their ability to conduct independent research through publication of several technical reports and/or peer-reviewed publications. The contractor will be expected to execute their assigned tasks, and to share their findings with other members of the project team. Possesses good written and oral communication skills. The Contractor is expected to write reports and publications, and present their findings in meetings.

Scientist 3**. The contractor shall be knowledgeable in a relevant field of the life sciences and have desired experience working in a research laboratory. The contractor shall have demonstrated their subject matter expertise in several areas, and their ability to conduct independent research through publication of several technical reports and/or peer-reviewed publications. Demonstrates experience managing a research laboratory and a small cadre of technicians. The contractor will be expected to execute their assigned tasks, and to share their findings with other members of the project team. Possesses good written and oral communication skills. The contractor is expected to write reports and publications, and present their findings in meetings.

Scientist 4**. The contractor shall be knowledgeable in a relevant field of the life sciences and have desired experience working in a research laboratory. The contractor shall have demonstrated their subject matter expertise in a number of areas, and their ability to conduct team-based research through publication of several technical reports and/or peer-reviewed publications. Demonstrates experience in the development of medical products for licensure by the FDA. Demonstrates experience managing a research laboratory, including technicians and other junior scientists. The contractor will be expected to execute their assigned tasks, and to share their findings with other members of the project team. Possesses excellent written and oral communication skills. The contractor is expected to write reports and publications, and present their findings in meetings. Performs a variety of complicated tasks.

Scientist 5**. The contractor shall be knowledgeable in a relevant field of the life sciences and have desired experience working in a research laboratory. The contractor shall be a recognized expert in their area of expertise, as demonstrated by their publication record or industry experience. They will have demonstrated their subject matter expertise in a number of areas, and their ability to conduct team-based research through publication of several technical reports and/or peer-reviewed publications. Demonstrates experience in the development of medical products for licensure by the FDA. Demonstrates experience in managing a research laboratory, including technicians and other scientists. The contractor will be expected to execute their assigned tasks, and to share their findings with other members of the project team. Possesses excellent written and oral communication skills. The contractor is expected to write reports and publications, and present their findings in meetings. May provide consultation on complex projects.

Subject Matter Expert **. Contractor shall have the desired experience directly related to work experience and be a recognized expert in the required area of expertise. Contractor will serve as the subject matter expert in required areas of expertise and provide industry best practice solutions to extremely complex problems being addressed. The contractor shall have the ability to analyze these extremely complex problems and recommend, monitor and execute best practice solutions to executive level management. Possesses good written and oral communication skills, along with the ability to work well in teams. An advanced degree, professional degree, professional licensure, and/or board certification from a recognized accrediting body may be required, depending on the subject matter area of expertise required.

Technical Writer 1. Writes a variety of technical articles, reports, brochures, user guides, training materials, manuals, and other technical documentation for a wide range of uses by applying word processing, graphics and audio visual communications techniques for technical or scientific subject matter. Desires experience in a research setting and familiarity with a variety of scientific and research concepts, practices, and procedures. For information technology writing, desires experience with planning, developing, maintaining, rewriting, and producing computer software/systems related documentation including tailoring style and readability to user requirements. Assists programmers and engineers with developing on-line documentation. Relies on instructions and pre-established guidelines to perform the functions of the job.

Technical Writer 2. Writes a variety of technical articles, reports, brochures, user guides, training materials, manuals, and other technical documentation for a wide range of uses by applying word processing, graphics and audio visual communications techniques for technical or scientific subject matter. Possesses experienced in a research setting and familiarity with a variety of scientific and research concepts, practices, and procedures. For information technology writing, desires experience with planning, developing, maintaining, rewriting, and producing computer software/systems related documentation including tailoring style and readability to user requirements. Assists programmers and engineers with developing on-line documentation. Performs a variety of tasks including preparing complex report documents from raw and processed data; and manipulating data and scientific findings into tables and text for presentation in a logical fashion.

Technical Writer 3. Writes a variety of technical articles, reports, brochures, user guides, training materials, manuals, and other technical documentation for a wide range of uses by applying word processing, graphics and audio visual communications techniques for technical or scientific subject matter. Possesses experience in a research setting with a variety of scientific and research concepts, practices, and procedures. For information technology writing, desires experience with planning, developing, maintaining, rewriting, and producing computer software/systems related documentation including tailoring style and readability to user requirements. Assists programmers and engineers with developing on-line documentation. Performs a variety of tasks including preparing complex report documents from raw and processed data; and manipulating data and scientific findings into tables and text for presentation in a logical fashion.

Technology Transfer Associate 1. Provides support to the Institute’s staff to develop and prepare intergovernmental and technology transfer agreements to include interagency agreements (IAA), cooperative research and development agreements (CRADA), material transfer agreements (MTA) and nondisclosure agreements (NDA).