Current jobs related to Regulatory Affairs Specialist - Silver Spring, Maryland - National Institutes of Health

  • Medical Officer

    2 weeks ago

    Silver Spring, Maryland, United States AE Strategies Full time

    Contribute to the Overall Public GoodAs a Medical Officer at AE Strategies, you will have the opportunity to make a meaningful impact on the global healthcare landscape. Working with the Food and Drug Administration (FDA) offers a unique chance to contribute to the overall public good on a far greater scale.Key Responsibilities:Ensure the safety and...

  • Physician Reviewer

    2 weeks ago

    Silver Spring, Maryland, United States AE Strategies Full time

    Job Summary:The Clinical Trials Reviewer is a key position at AE Strategies, requiring a physician with expertise in regulatory affairs and clinical trials. This role involves reviewing new drugs to ensure their safety and efficacy, working closely with the team to make evidence-based decisions, and staying up-to-date on scientific...

  • Oncology Regulatory Affairs Specialist

    4 weeks ago

    Silver Spring, Maryland, United States AE Strategies Full time

    About AE StrategiesAt AE Strategies, we are dedicated to enhancing cancer treatment through rigorous regulatory oversight and collaboration with healthcare professionals, researchers, and regulatory bodies. Our mission is to ensure that patients have access to safe and effective oncology therapies.Position OverviewAs a Medical Officer specializing in...

  • Oncology Regulatory Affairs Specialist

    4 weeks ago

    Silver Spring, Maryland, United States AE Strategies Full time

    About AE StrategiesAt AE Strategies, we are dedicated to enhancing cancer treatment through collaboration with researchers, patients, and regulatory bodies. Our focus on public health and patient-centered regulatory practices drives our mission to ensure the availability of safe and effective oncological therapies.Position OverviewAs a Medical Officer...

  • Oncology Regulatory Affairs Specialist

    4 weeks ago

    Silver Spring, Maryland, United States AE Strategies Full time

    Overview of AE Strategies - Our MissionAt AE Strategies, we are dedicated to enhancing cancer treatment through collaboration with researchers, patients, and regulatory bodies. Our focus on public health and patient-centered regulatory practices drives our commitment to ensuring the availability of safe and effective oncological therapies.Our professionals...

  • Regulatory Medical Officer

    10 hours ago

    Silver Spring, Maryland, United States AE Strategies Full time

    Join Our Team as a Regulatory OncologistWe are seeking a highly skilled Regulatory Oncologist to join our team at AE Strategies. As a key member of our team, you will play a critical role in ensuring the safety and effectiveness of cancer treatments.Key Responsibilities:Ensure the safety and efficacy of cancer treatments through rigorous review and approval...

  • Regulatory Policy Specialist

    4 weeks ago

    Silver Spring, Maryland, United States DRT Strategies, Inc. Full time

    Job OverviewDRT Strategies, Inc. is a leading management consulting firm that provides specialized consulting and IT solutions to federal agencies, state and local governments, and commercial clients across various sectors including healthcare, technology, and financial services.Core Philosophy: Our name, DRT, stands for Driving Resolution Together,...

  • Regulatory Physician

    2 weeks ago

    Silver Spring, Maryland, United States AE Strategies Full time

    About the RoleWe are seeking a highly skilled Regulatory Physician to join our team at AE Strategies. As a Clinical Reviewer, you will play a critical role in ensuring the safety and effectiveness of drugs, medical devices, and other products regulated by the FDA.Key ResponsibilitiesRegulatory Review: Conduct thorough reviews of drug and device applications...

  • Medical Officer

    5 days ago

    Silver Spring, Maryland, United States FDA Full time

    Job SummaryWe are seeking a highly skilled Medical Officer to join our team at the FDA. As a Medical Officer, you will play a critical role in ensuring the safety and effectiveness of human drugs, vaccines, and medical devices.Key ResponsibilitiesEnsuring Drug Safety and Effectiveness: Conduct inspections and investigations of drug manufacturing...

  • Budget and Fiscal Compliance Specialist

    2 weeks ago

    Silver Spring, Maryland, United States HIAS Full time

    Job SummaryHIAS is seeking a highly skilled Budget and Fiscal Compliance Specialist to support our North America Programs in the creation and management of budgets, as well as the management of grants and cooperative agreements from initiation to closure in the United States and overseas.Key ResponsibilitiesGrant Management: Manage reporting, compliance, and...

  • Clinical Reviewer

    2 weeks ago

    Silver Spring, Maryland, United States AE Strategies Full time

    Job Summary:AE Strategies is seeking a highly skilled Clinical Reviewer to join our team. As a Clinical Reviewer, you will play a critical role in ensuring the safety and efficacy of new drugs.Key Responsibilities:Pre-Approval Review: Conduct thorough reviews of new drug applications to ensure they meet regulatory requirements.Post-Approval Monitoring:...

  • Credentialing Specialist

    5 days ago

    Silver Spring, Maryland, United States Community Clinic Full time

    Credentialing Coordinator Job DescriptionAt Community Clinic, we are seeking a highly organized and detail-oriented Credentialing Coordinator to join our team. As a Credentialing Coordinator, you will play a critical role in ensuring that our healthcare providers are properly licensed and credentialed to provide high-quality care to our patients.Key...

  • BSA/AML Systems Specialist

    4 weeks ago

    Silver Spring, Maryland, United States Veritas Partners Full time

    Position OverviewVeritas Partners is seeking an experienced AML/BSA Systems Administrator to oversee the effective management and enhancement of our client's AML system. The role entails ensuring the system's operational efficiency and compliance with regulatory standards.Key ResponsibilitiesOversee the implementation of new BSA/AML systemsEnhance and...

  • Credentialing Specialist

    1 week ago

    Silver Spring, Maryland, United States Community Clinic Full time

    {"Position Summary": "The Credentialing Coordinator will be responsible for credentialing new and established healthcare providers, maintaining provider information, and ensuring compliance with regulatory guidelines. This role requires strong organizational and analytical skills, with attention to detail and excellent communication skills.", "Key Functions...

  • Records Management Specialist

    1 week ago

    Silver Spring, Maryland, United States Puente de Vida LLC Full time

    Job SummaryPuente de Vida LLC is seeking an experienced Records Management Specialist to provide support to our team. The ideal candidate will have a strong background in records management, including conducting inventories, developing file plans, and drafting records control schedules.Key ResponsibilitiesConduct comprehensive records inventories to ensure...

  • Medical Officer

    6 days ago

    Silver Spring, Maryland, United States AE Strategies Full time

    Contribute to Global Public Health at the FDAAs a medical officer at the Food and Drug Administration (FDA), you will play a critical role in ensuring the safety and effectiveness of human drugs, vaccines, and medical devices. Your contributions will have a direct impact on public health, both domestically and globally.Key Responsibilities:Ensure the safety...

  • Budget and Fiscal Compliance Specialist

    3 days ago

    Silver Spring, Maryland, United States HIAS Full time

    Job SummaryHIAS is seeking a highly skilled Budget and Fiscal Compliance Specialist to support our North America Programs in the creation and management of budgets, as well as the management of grants and cooperative agreements from initiation to closure in the United States and overseas.Key ResponsibilitiesManage reporting, compliance, and recognition of...

  • Credentialing Specialist

    3 weeks ago

    Silver Spring, Maryland, United States Community Clinic Full time

    Job SummaryThe Credentialing Coordinator will be responsible for credentialing new and established healthcare providers, maintaining information, and ensuring compliance with regulatory guidelines.Key ResponsibilitiesMaintain a provider database to ensure all healthcare providers are licensed and properly credentialed.Process initial and reappointment...

  • Claims Specialist

    6 days ago

    Silver Spring, Maryland, United States CCI Health & Wellness Services Full time

    Job SummaryCci Health & Wellness Services is seeking a skilled Claims Specialist to join our team. As a Claims Specialist, you will play a critical role in ensuring that services are promptly and accurately processed in accordance with all applicable Federal, State, and local regulations and guidelines.Key ResponsibilitiesReview and analyze encounters to...

  • Credentialing Specialist

    7 hours ago

    Silver Spring, Maryland, United States Community Clinic Full time

    Job Title: Credentialing CoordinatorCredentialing Coordinator is a key role at Community Clinic, responsible for ensuring that healthcare providers are properly licensed and credentialed to deliver high-quality care to our patients.Job Summary:The Credentialing Coordinator will be responsible for maintaining accurate and up-to-date information on healthcare...

Regulatory Affairs Specialist

3 months ago

Silver Spring, Maryland, United States National Institutes of Health Full time

Summary

All candidates should make sure to read the following job description and information carefully before applying.

The Research Regulatory Affairs-Facilities organization within ORSC provides regulatory support for the various cGMP and compounding facilities on campus. Support includes guidance in meeting the regulatory requirements with regards to facility design and facility operations. The area maintains centralized resource contracts such as for specialized cleaning and preventative maintenance, will aid in FDA Inspections of facilities, aide in development of Quality Systems, and responses to audits.

Duties

As a GS-0601 Regulatory Affairs Specialist in the Clinical Center, your duties may include but are not limited to the following:

  • Direct responsibility using knowledge of regulatory statutes and guidance for the oversight and monitoring of NIH research facilities to ensure compliance with pertinent regulations, applicable policies, standards and procedures as well as with state of the art methods using sound scientific principles as they apply to regulated cleaning services, pest management, regulatory required environmental monitoring, qualification and management of manufacturing materials and hospital supplies.
  • Use regulatory knowledge of the requirements for cGMP and compounding facilities; selects, qualifies and oversees the speciality contracts for cleaning services, pest management, environmental monitoring (to include indentification of specific disinfectants based on the microbial results from monitoring), materials management and vendor qualifications for suppliers.
  • Provide high level consultative support to the Clinical Center and Institute departments including Pharmacy/IVAU Department, Department of Transfusion Medicine (DTM), Department of Laboratory Medicine (DLM), Positron Emission Tomography (PET) Department, and the Nuclear Medicine Department, NCI Surgery Branch and NIAID Malaria Branch regarding regulatory compliance with the U.S. Food and Drug Administration (FDA) regulations, USP and other pertinent regulations and policies and industry standards regarding research facilities.
  • Provide regulatory support for investigators from NIH Institutes performing FDA regulated research including assisting investigators in meeting the Food and Drug Administration requirements and in reviewing and preparing protocols.
  • Use expertise in FDA and USP regulations and guidance, identifies and designs customized audit and evaluation surveys for each facility, develops protocols to evaluate and validate internal and external research facilities to ensure they meet the regulatory statutes and NIH manufacturing and compounding quality requirements.
  • Prepare NIH guidance and policy; identifies core manufacturing staff technical competencies and provides training; and determines opportunities for efficiencies, effectiveness and cost savings in research facilities throughout the NIH.
  • Develop appropriate metrics regarding the quality of research facilities and monitors and reports on them.
Requirements
Conditions of Employment
  • U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
  • Employment is subject to the successful completion of a background investigation, verification of qualifications, completion of onboarding forms, submission of required documents, and any other job-related requirement before or after appointment.
  • Applicants must meet all qualification requirements by the closing date of this announcement.
  • Males born after December 31, 1959 must be registered with the Selective Service.
  • This position has an education requirement. You are strongly encouraged to submit a copy of your transcripts.
  • If selected, you must pass a pre-employment medical examination, provide evidence of immunization, and be free from communicable diseases.
  • At the supervisors discretion, this position may offer work schedule flexibilities: Telework and Alternative Work Schedules.
  • This position is designated as an "emergency essential" position. See definition of this designation in the Additional Information Section of this announcement.
Qualifications
Basic Education Requirement for GS-601:

In order to qualify for a Regulatory Affairs Specialist-GS-601, position you must have successfully completed a full 4 year course of study in an accredited college or university leading to a Bachelor's degree or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. (This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained).

In addition, in order to qualify for a Regulatory Affairs Specialist, 0601 at the GS-11 level, you must meet one (1) of the following qualification requirements:

A. 3 years of progressively higher level graduate education leading to a Ph.D. degree or Ph.D. or equivalent doctoral degree;

OR

B. Have 1 year of specialized experience equivalent to at least the GS-9 level in the Federal service obtained in either the private or public sector, performing the following types of tasks: assisting clinical investigators in meeting FDA regulatory research requirements; analyzing and revising protocols by ensuring regulations, guidelines, and practices of research facilities are followed; assisting in conducting evaluations and audits to evaluate and validate research facility operations; drafting and reviewingreports of findings to implement improvements and corrective action plans to ensure the compliance of regulations governing cGMP and compounding facilities; and arranging highly technical contracts for research facilities.

OR

C. have a combination of graduate education related to the position and experience that meets 100% of the qualification requirements for this position.

In addition, in order to qualify for a Regulatory Affairs Specialist-GS-601, at the GS-12 level, you must meet the following requirement:

Have at least one (1) year of qualifying specialized experience equivalent to at least the GS-11 level in the Federal Government obtained in either the private or public sector performing the following types of tasks: Interpreting and applying knowledge of various regulations, policies and procedures in research facilities; designing and conducting audits and surveys for the compliance of FDA and USP regulations; serving as a liaison and providing regulatory guidance for clinical investigators and other clinical regulatory staff; preparing a variety of materials including briefings, project papers, correspondence and presentations for leadership regarding the quality of research facilities;and preparing reports of audit findings and recommendations to improve research facility operations.

You will receive credit for all experience material to the position, including experience gained in religious, civic, welfare, service, and organizational activities, regardless of whether you received pay.

Do not copy and paste the duties, specialized experience, or occupational assessment questionnaire from this announcement into your resume as that will not be considered a demonstration of your qualifications for this position.

Preview assessment questionnaire before you apply: How You Will Be Evaluated

You will be evaluated for this job based on how well you meet the qualifications above.

You will be assessed on the following competencies (knowledge, skills, abilities, and other characteristics):

  • 1. Knowledge of the principles, theories, and methods of quality assurance and quality improvement, as relates to aseptic manufacturing and compounding facility operations.
  • 2. Ability to plan, evaluate, and audit processing/compounding facility operations.
  • 3. Knowledge of CFR, FDA and USP regulatory compliance procedures and protocol guidelines.
  • 4. Ability to collaborate and communicate with research professionals and various organizational entities regarding aseptic manufacturing and compounding facility programs and operations.
If you meet the minimum qualifications for this position, your application and responses to the online questionnaire will be evaluated under Category Rating and selection procedures for placement in one of the following categories:
  • Best Qualified - for those who are superior in the evaluation criteria
  • Well Qualified - for those who excel in the evaluation criteria
  • Qualified - for those who only meet the minimum qualification requirements
The Category Rating Process does not add veterans' preference points but protects the rights of veterans by placing them ahead of non-preference eligibles within each category. Applicants determined to be Best Qualified will be referred for further consideration. Preference eligibles in the Best Qualified category are referred before all other applicants.

To determine your qualifications and referral status, we may review your resume and supporting documentation and compare it against your responses to the vacancy questionnaire. Ensure you support your self-ratings by the information you provide in your application. We may verify or assess your qualifications at any time. Inflated or unsupported qualifications may affect your rating. Any misrepresentation or material omission of facts may be sufficient cause to end further consideration of your candidacy. Persons listed as having knowledge of your past accomplishments or experience in your application may be contacted for verification purposes at any time. Verification may, but need not, begin prior to receiving an offer.

To be considered well qualified for the purposes of the and the , you must be able to satisfactorily perform the duties of the position upon entry and substantively exceed the basic qualifications by scoring at least an 85 on the assessment and meet all eligibility, physical, medical, suitability, and all other requirements.

Required Documents

REQUIRED FOR ALL APPLICANTS

RESUME:

Your resume must thoroughly describe how your skills and experiences align to the criteria defined in the "Qualifications" section of this announcement and it must support your responses to the assessment questionnaire. We cannot assume you have performed the necessary experience required for this position regardless of your employment history or academic career.

To ensure all of the essential information is in your resume, we encourage you to use the . If you choose to use your own resume, you must ensure it contains all of the required information and you organize it so we can associate the following information for each experience/position:

  1. Job title
  2. Name of employer
  3. Beginning and ending dates of employment (month/day/year format)
  4. Hours worked per week. We will assume full-time unless otherwise stated. We will prorate part-time employment in crediting experience.
  5. Detailed description of job duties, accomplishments, related skills, and responsibilities to include any supervisory/managerial responsibilities and number of staff supervised (if applicable)
  6. Series and grade or equivalent (if a federal position)
If the position has an education requirement or you are qualifying on the basis of education, you must list your education history including the type of degree and your major of study. If the position requires a certain number of credit hours, you are strongly encouraged to list the relevant courses in your resume.

Do not include a photograph or video of yourself, or any sensitive information (age, date of birth, marital status, protected health information, religious affiliation, social security number, etc.) on your resume or cover letter. We will not access web pages linked on your resume or cover letter to determine your qualifications.

For resume writing guidance, please visit the following resources: , , and the .

ASSESSMENT QUESTIONNAIRE:

You must submit a completed assessment questionnaire.

Unless otherwise stated, we will only use the information above to determine your qualifications. Not providing the required information may result in a determination that you do not meet minimum requirements for the position (e.g., an ineligible rating) or a lower rating.

REQUIRED DOCUMENTATION FOR PREFERENCE OR ELIGIBILITY CLAIMS

To claim veterans' preference, career transition selection priority, Schedule A or military spouse eligibility, you must provide the documentation listed below AND respond accordingly to the associated question on the online questionnaire.
  • (DD-214, VA Disability Letter, etc.): Reference for required documentation for 10 point claims. Submission of SF-15 is not required, unless you are claiming derived preference (XP) as described in questions 7, 8, or 9 on the SF-15. In those cases, you must submit a completed SF-15 and the required documentation. For 5 point claims, you must submit your DD-214 (if separated) or any written documentation from the armed forces that certifies you are expected to be discharged or released from active duty service in the armed forces under honorable conditions not later than 120 days after the date the is submitted with your application package.
  • Visit our sites on / for more information and required documentation.
  • Visit our site on the for more information and required documentation to verify eligibility.
  • Schedule A Eligibility (Applicants with Disabilities) Applicants who are eligible to be considered under must submit appropriate documentation to verify eligibility. Documentation must be obtained from a licensed medical professional (e.g., a physician or other medical professional certified by a state, the District of Columbia, or a U.S. territory to practice medicine); a licensed vocational rehabilitation specialist (i.e., state or private); or any Federal agency, state agency, or agency of the District of Columbia or a U.S. territory that issues or provides disability benefits. The letter must be printed on a medical professional's letterhead and signed. Veterans' preference takes precedence in these appointments.
The Schedule A and military spouse hiring authorities do not guarantee employment or give an individual preference in the hiring process.

If you do not provide the required information, we will assume you are not eligible, or you do not wish to be considered for any preference or eligibility.

Do not submit documentation that is not requested of you. To protect your personal information, we will only send your resume and cover letter to the selecting official or hiring manager.

If you are relying on your education to meet qualification requirements:

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from
.

Failure to provide all of the required information as stated in this vacancy announcement may result in an ineligible rating or may affect the overall rating.

PDN-9c2bf162-9ab9-4527-a723-d5e4b9d6d947