regulatory affairs specialist

Amgen

<div><div>Egypt - Cairo
<div>JOB ID: R-251623 LOCATION: Egypt - Cairo WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Jul. 29, 2026 CATEGORY: Regulatory
</div></div><div><div>HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. At Amgen our shared mission&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies. We are global collaborators who achieve together&mdash;researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It&rsquo;s time for a career you can be proud of. Join us.
SENIOR ASSOCIATE REGULATORY AFFAIRS
WHAT YOU WILL DO
In this vital role you will assist in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements, and Regulatory Affairs processes and deliverables for the ELI markets Egypt, Jordan, Iraq and Lebanon.<ul><li>
Ensure regulatory submissions are made on time and meet Amgen&rsquo;s corporate and local regulatory requirements</li><li>
Responsible for completion of regulatory files for submission. (Prepare/Receive files and submit them to regulatory authorities within the defined and agreed submission/approval dates) and according to guidelines and requirements</li><li>
Manufacturing site registration and license maintenance</li><li>
Responsible for coordinating with the International regulatory team to ensure right first-time dossiers are provided</li><li>
Coordinate and respond to the requests by authorities during the evaluation process and check the correct handling of deficiency letter within a specific timeframe in order not to delay MOH approvals</li><li>
Establish effective communication and continuous follow-up with the external agencies &amp; distributors to ensure timely submissions and approvals of all company&rsquo;s applications</li><li>
Monitoring of emerging guidelines and changes affecting business and communication to relevant internal customers</li><li>
Providing guidance on the approval processes to internal stakeholders within the region and providing regulatory input for launch planning</li><li>
Maintenance of all lifecycle activities/ Product renewal license details by accurately preparing filling submissions and approval within the preset global timelines -accountable for overall accuracy and compliance</li><li>
Ensure alignment of regulatory objectives with regional / global regulatory objectives and commercial plans</li><li>
Accountable for solving all supply issues related to regulatory activities.</li><li>
To provide regulatory intelligence</li><li>
Ensure compliance with company's SOPs and working practices for Good Regulatory Practice</li><li>
Management of documentation archiving and record keeping according to SOP and local legislation</li><li>
Contact for agency interactions for portfolio of products and coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies</li><li>
Collate, distribute, exchange and archive regulatory information with colleagues across the business</li><li>
Participate in regulatory and affiliate process improvements initiatives</li><li>
Review promotion and non-promotion materials to ensure compliance with local license, company procedures and Code of Practice</li></ul>
BE PART OF OUR TEAM
Reporting to the Regulatory Affairs Manager for ELI, you would be joining a team of regulatory professionals passionate about delivering the best outcomes for our medicines to patients.
WHAT WE EXPECT OF YOU
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:<ul><li>
Pharmacy Bachelor&rsquo;s degree</li><li>
2-3 years of directly related experience in regulatory affairs (ELI markets)</li><li>
Knowledge and awareness of the relevant regulatory guidelines and legislation for ELI markets</li><li>
Strong communication skills both verbal and written</li><li>
Organizational skills &amp; developing regulatory project management skills</li></ul>
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates&rsquo; professional and personal growth and well-being.<ul><li>
Vast opportunities to learn and move up and across our global organization</li><li>
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act</li><li>
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits</li></ul>
 for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status.</div></div></div>

Senior Associate Regulatory Affairs

<div>
 
 HOW MIGHT YOU DEFY IMAGINATION?
 
 
 
 If you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. At Amgen our shared mission&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies. We are global collaborators who achieve together&mdash;researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It&rsquo;s time for a career you can be proud of. Join us.
 
 
 
 SENIOR ASSOCIATE REGULATORY AFFAIRS
 
 
 
 
 What You Will Do
 
 
 
 In this vital role you will assist in the local coordination and execution of regulatory submissions in compliance with Amgen corporate standards and national regulatory requirements, and Regulatory Affairs processes and deliverables for the ELI markets Egypt, Jordan, Iraq and Lebanon.
 
 
 <ul>
 <li>
 Ensure regulatory submissions are made on time and meet Amgen&rsquo;s corporate and local regulatory requirements
 </li>
 <li>
 Responsible for completion of regulatory files for submission. (Prepare/Receive files and submit them to regulatory authorities within the defined and agreed submission/approval dates) and according to guidelines and requirements
 </li>
 <li>
 Manufacturing site registration and license maintenance
 </li>
 <li>
 Responsible for coordinating with the International regulatory team to ensure right first-time dossiers are provided
 </li>
 <li>
 Coordinate and respond to the requests by authorities during the evaluation process and check the correct handling of deficiency letter within a specific timeframe in order not to delay MOH approvals
 </li>
 <li>
 Establish effective communication and continuous follow-up with the external agencies &amp; distributors to ensure timely submissions and approvals of all company&rsquo;s applications
 </li>
 <li>
 Monitoring of emerging guidelines and changes affecting business and communication to relevant internal customers
 </li>
 <li>
 Providing guidance on the approval processes to internal stakeholders within the region and providing regulatory input for launch planning
 </li>
 <li>
 Maintenance of all lifecycle activities/ Product renewal license details by accurately preparing filling submissions and approval within the preset global timelines -accountable for overall accuracy and compliance
 </li>
 <li>
 Ensure alignment of regulatory objectives with regional / global regulatory objectives and commercial plans
 </li>
 <li>
 Accountable for solving all supply issues related to regulatory activities.
 </li>
 <li>
 To provide regulatory intelligence
 </li>
 <li>
 Ensure compliance with company's SOPs and working practices for Good Regulatory Practice
 </li>
 <li>
 Management of documentation archiving and record keeping according to SOP and local legislation
 </li>
 <li>
 Contact for agency interactions for portfolio of products and coordinating and reviewing briefing documents and/or other submissions for meetings with Regulatory agencies
 </li>
 <li>
 Collate, distribute, exchange and archive regulatory information with colleagues across the business
 </li>
 <li>
 Participate in regulatory and affiliate process improvements initiatives
 </li>
 <li>
 Review promotion and non-promotion materials to ensure compliance with local license, company procedures and Code of Practice
 
 
 </li>
 </ul>
 
 BE PART OF OUR TEAM
 
 
 
 Reporting to the Regulatory Affairs Manager for ELI, you would be joining a team of regulatory professionals passionate about delivering the best outcomes for our medicines to patients.
 
 
 
 What We Expect Of You
 
 
 
 We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
 
 
 <ul>
 <li>
 Pharmacy Bachelor&rsquo;s degree
 </li>
 <li>
 2-3 years of directly related experience in regulatory affairs (ELI markets)
 </li>
 <li>
 Knowledge and awareness of the relevant regulatory guidelines and legislation for ELI markets
 </li>
 <li>
 Strong communication skills both verbal and written
 </li>
 <li>
 Organizational skills &amp; developing regulatory project management skills
 
 
 </li>
 </ul>
 
 Thrive
 
 
 
 
 What You Can Expect Of Us
 
 
 
 As we work to develop treatments that take care of others, so we work to care for our teammates&rsquo; professional and personal growth and well-being.
 
 
 <ul>
 <li>
 Vast opportunities to learn and move up and across our global organization
 </li>
 <li>
 Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
 </li>
 <li>
 Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
 
 
 </li>
 </ul>
 
 Apply now for a career that defies imagination
 
 
 
 In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
 
 
 
 careers.amgen.com
 
 
 
 Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
</div>

University of Southern California

<div>Job ID REQ20178332 Category Nursing</div>
 <div>Clinical Research Regulatory Specialist - Operations
The University of Southern California (USC), founded in 1880, is one of the world&rsquo;s leading private research universities and the largest private employer in the City of Los Angeles. As a member of the Trojan Family, you will join a vibrant community of faculty, staff, students, and researchers dedicated to advancing knowledge, innovation, and excellence in education, research, and patient care.
Position Summary:
Reporting to the Assistant Director of Clinical Research Operations, the Regulatory Affairs Specialist is responsible for overseeing and managing the regulatory aspects of clinical research studies conducted through the Clinical Trials Office. This role independently manages complex, multi-phase clinical research protocols from study start-up through closeout, ensuring compliance with all applicable federal, state, local, sponsor, and institutional regulations governing human subjects research.
The Regulatory Affairs Specialist serves as the primary regulatory resource for non-cancer clinical trials and is responsible for coordinating, preparing, and maintaining regulatory documentation for industry-sponsored, federally funded, and investigator-initiated studies. The incumbent will lead regulatory-related study meetings, maintain investigator site files, ensure the timely collection and maintenance of essential documents, and support study teams in meeting all regulatory requirements throughout the lifecycle of a clinical trial.
This position plays a key role in developing and implementing processes that promote regulatory compliance, data integrity, and adherence to Good Clinical Practice (GCP), institutional standard operating procedures (SOPs), and University policies.
Key Responsibilities:
<ul><li>Manage all regulatory activities for assigned clinical research studies from study initiation through closeout.
</li><li>Prepare, submit, and track regulatory submissions, including Initial Applications, Amendments, Continuing Reviews, and Reportable Events to the Institutional Review Board (IRB), Food and Drug Administration (FDA), sponsors, and other regulatory agencies as required.
</li><li>Ensure timely reporting of regulatory submissions, adverse events, protocol deviations, and other reportable events in accordance with applicable regulations and study requirements.
</li><li>Maintain accurate and audit-ready investigator site files and essential regulatory documentation.
</li><li>Collaborate with Principal Investigators, study coordinators, sponsors, and research staff to ensure ongoing regulatory compliance.
</li><li>Serve as a liaison with regulatory and compliance entities, including the IRB, FDA, sponsor representatives, monitors, and external agencies.
</li><li>Participate in and lead study-related regulatory meetings, providing guidance on regulatory requirements and compliance considerations.
</li><li>Maintain accurate study information within the Clinical Trial Management System (OnCore) and electronic regulatory system (Florence).
</li><li>Develop and implement workflows and best practices that enhance regulatory oversight, documentation quality, and study compliance.
</li><li>Support audit and inspection readiness activities and assist with responses to regulatory findings, when necessary.
</li><li>Ensure adherence to Good Clinical Practice (GCP), institutional policies, sponsor requirements, and all applicable regulatory standards.
</li></ul>Required Qualifications:
<ul><li>Demonstrated experience preparing and submitting IRB applications, including Initial Reviews, Amendments, Continuing Reviews, and Reportable Events.
</li><li>Strong knowledge of clinical research regulatory processes and documentation requirements.
</li><li>Excellent interpersonal skills with the ability to build and maintain effective working relationships across the Health System.
</li><li>Exceptional organizational skills with meticulous attention to detail.
</li><li>Ability to effectively manage multiple priorities, adapt to changing demands, and meet critical deadlines in a fast-paced environment.
</li><li>Strong analytical and problem-solving skills, with the ability to identify issues, develop solutions, and implement corrective actions independently.
</li><li>Proven ability to exercise sound judgment, discretion, and independent decision-making.
</li><li>Excellent written and verbal communication skills.
</li><li>Ability to research, evaluate, interpret, and synthesize complex information and prepare clear, concise reports and correspondence.
</li><li>Strong customer service orientation and commitment to responsive stakeholder support.
</li><li>High level of professionalism, integrity, and discretion in handling confidential information.
</li><li>Ability to work independently while contributing effectively as part of a collaborative team.
</li><li>Proficiency with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Teams) and virtual meeting platforms such as Zoom.
</li><li>Demonstrated ability to establish and maintain accurate files, records, and regulatory documentation.
</li><li>Experience working effectively with individuals from diverse cultural, educational, and professional backgrounds.
</li></ul>Minimum Qualifications:
<ul><li>High school diploma or equivalent combined with sufficient experience and demonstrated competencies required to successfully perform the duties of the position.
</li><li>Bachelor&rsquo;s degree preferred.
</li><li>Minimum of 3-5 years of clinical research regulatory experience as a Regulatory Affairs Coordinator (RAC) or Assistant Regulatory Affairs Coordinator, or an equivalent combination of education and experience.
</li></ul>Preferred Qualifications:
<ul><li>Working knowledge of federal, state, local, and institutional regulations governing clinical research and human subject protections.
</li><li>Experience supporting a variety of clinical trial types, including industry-sponsored, federally funded, cooperative group, and investigator-initiated studies.
</li><li>Research certification such as ACRP, SoCRA, CCRP, or equivalent.
</li><li>Current CITI Human Subjects Research certification.
</li><li>Demonstrated expertise in clinical research regulatory compliance, including Phase I-IV drug studies and medical device trials.
</li><li>Comprehensive understanding of IRB processes, FDA regulations, and regulatory requirements throughout the clinical trial lifecycle.
</li><li>Experience with Clinical Trial Management Systems (OnCore) and electronic regulatory systems (Florence) preferred.
</li></ul>Follows established USC and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan.
This position is remote. Work hours and remote days may be subject to change depending on business needs.
The annual range for this position is $75,968.95 - $ 101,364.43. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations 
 
Minimum Education: Bachelor's degree Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years Addtional Experience Requirements Combined experience/education as substitute for minimum work experience Minimum Skills: Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE). Knowledgeable of Informational Conference on Harmonization-Good Clinical Practice (ICHGCP), Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) and FDA regulations and procedures. Ability to evaluate the risks and benefits of different solutions, and proven problem-solving and decision-making skills to uncover causes of problems. Exemplary organization skills and attention to detail. Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements. Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and varied individuals and groups. Demonstrated experience developing communication plans, instructional materials and related content. Experience with office management communication software/tools (e.g., Google suite, Slack, Skype). Preferred Education: Bachelor's degree Preferred Experience: 3 years in clinical research compliance, regulatory research and/or operations in the academic or private sector Preferred Skills: Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials. Advanced knowledge of regulations governing human research.
<div>Job ID REQ20178332 Posted Date 07/30/2026</div></div>

Clinical Research Regulatory Specialist

Brown University Health

<div><ul><li>Job ID: JR-112254
</li><li>Entity: Rhode Island Hospital
</li><li>Location Name: Rhode Island Hospital
</li><li>City, State: Providence, RI
</li><li>Work Type: FULL TIME
</li><li>Hours Per Week: 40
</li><li>Shift: Day
</li><li>Posted Date: 7/30/2026
</li></ul><div><h2 class="jobSectionHeader">SUMMARY</h2>

The Sr. Research Regulatory Coordinator is responsible for clinical studies through the regulatory portion of the trial submission process to maintaining the regulatory integrity of assigned clinical trials from approval to closure. The Sr. Research Regulatory Coordinator performs multiple tasks in order to meet compliance requirements in research. This position will be overseeing clinical research regulatory requirements for the department. The Sr. Research Regulatory Coordinator will provide support in managing the clinical trials within the department, instructs and advises other staff in regulatory/compliance issues and collaborates with investigators to resolve all regulatory inquiries. The Sr. Research Regulatory Coordinator shall work closely with department leadership.

Brown University Health employees are expected to successfully role model the organization&rsquo;s values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another.

In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include:
<ul>
<li>Instill Trust and Value Differences</li>
<li>Patient and Community Focus and Collaborate</li>
</ul><h2 class="jobSectionHeader">RESPONSIBILITIES</h2>

The Sr. Research Regulatory Coordinator is responsible for all duties listed under the Regulatory Coordinator position, such as:
<ul>
<li>Develops protocols with the Principle Investigator and provides recommendations on research plan</li>
<li>Coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) including communicating with ancillary committees, study team, business office, contract research organizations, and sponsors</li>
<li>Prepare and maintain study specific regulatory binder(s) and documents</li>
<li>Serves as the regulatory subject matter expert through all phases of a clinical study, including regulatory documents and/or processes related to clinical trials conduct</li>
<li>Initiates and leads special projects, to include process improvement and regulatory training</li>
<li>Ensures proper regulatory compliance in accordance with sponsoring agency requirements</li>
<li>Liaises with sponsors, investigators and team members, providing trial information and updates as required in written, oral and meeting format, adhering to appropriate timelines</li>
</ul>
Additionally, the Sr. Research Regulatory Coordinator position will be responsible for the following:
<ul>
<li>Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications. Manages the preparation of annual reports to the FDA, as necessary. Manages and updates clinical trial/study information located on the clinicaltrials.gov website, as needed</li>
<li>Ensuring the collection and maintenance of credentialing information for study personnel. Such include conflict of interest forms (COI), CV&rsquo;s, MLs, HSP and GCP training</li>
<li>Coordinate audits and site visits with monitors concerning compliance of regulatory documents. Responsible for preparing for institutional, federal, and sponsor audits and assist with the drafting of audit responses</li>
<li>Assist with training of all regulatory affairs personnel with regards to regulatory compliance. Act as a mentor for new employees and find ways to improve the department&rsquo;s mentorship program</li>
<li>Work directly with department leadership to examine opportunities for regulatory innovation and promote the use of novel approaches within the project team to resolve issues and problems</li>
<li>Compile regulatory-related metrics for use by department leadership</li>
<li>Performs other duties as assigned</li>
</ul><h2 class="jobSectionHeader">MINIMUM QUALIFICATIONS</h2>
<h3 class="jobSectionHeader">BASIC KNOWLEDGE</h3>
<ul><li>Bachelor&rsquo;s degree in health-related or scientific field is required; Master&rsquo;s degree preferred</li>
<li>SoCRA (Society of Clinical Research Associates) certified or eligible within 18 months of hire</li>
<li>Sound knowledge of all federal, local and state guidelines pertaining to Clinical Research</li>
<li>Must be an independent person, who is capable of making sound judgment pertaining to regulatory issues and have the ability to work independently within the scope of the job requirements. Must demonstrate strong leadership and organizational skills</li>
</ul>
Must possess the following skills:
<ul>
<li>Detail-oriented and excellent organizational skills
</li>
<li>Strong self-starter
</li>
<li>Interpersonal skills
</li>
<li>Strong problem-solving skills
</li>
<li>Team-oriented
</li>
<li>Excellent oral and written communication skills
</li>
<li>Proficient in Microsoft Office and in various database applications
</li>
<li>Comprehensive knowledge of FDA guidelines
</li>
<li>Ability to foster smooth communications and teamwork among clinical research faculty, fellows and staff as well as external organizations necessary
</li>
</ul><h3 class="jobSectionHeader">EXPERIENCE</h3>
<ul><li>3-5 years in direct clinical trial administration experience or relevant clinical development and regulatory experience</li>
<li>Past experience in federal, state and/or local programmatic regulations compliance</li>
</ul><h2 class="jobSectionHeader">WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS</h2>

This position is a sedentary position. One must be able to transport paperwork to another building (sometimes up to 10 lbs.) at one time. Bending and stooping may also be requirements for filing of paperwork. Standing to copy may also be required.
<h2 class="jobSectionHeader">
INDEPENDENT ACTION</h2>

This position requires a quick-thinker, who can independently make basic and sometimes complex decisions pertaining to the completion and transmission of required regulatory documentation to internal departments as well as external agencies, including, but not limited to study sponsors, local and federal agencies. The candidate should be able to answer protocol regulatory inquiries from researchers and physicians, as well as from the local Institutional Review Board. This person should also be able to work with outside monitors and work independently. He/she should be able to answer inquiries related to regulatory issues, and if not known, communicate with the correct person to determine the answer.
<h2 class="jobSectionHeader">
SUPERVISORY RESPONSIBILITY</h2>

One to three regulatory staff members.
<h2 class="jobSectionHeader">
Pay Range</h2>

$64,480.00-$106,412.80
<h2 class="jobSectionHeader">
Location</h2>

Rhode Island Hospital - 593 Eddy Street Providence, Rhode Island 02903
<h2 class="jobSectionHeader">
Work Type</h2>

M-F 8am-4:30pm
<h2 class="jobSectionHeader">
Work Shift</h2>

Day
<h2 class="jobSectionHeader">
Daily Hours</h2>

8 hours
<h2 class="jobSectionHeader">
Driving Required</h2>

Yes

Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment.</div></div>

Sr Research Regulatory Coordinator 1

Beverly Hills Specialist Hospital

HR Officer for hospital

Booz Allen Hamilton

<div>The Opportunity:
Leverages scientific knowledge to support biological or biochemical research agendas. Applies specific functional knowledge and working and general industry knowledge. Develop s or contributes to solutions to a variety of problems of moderate scope and complexity. Works independently with some guidance, and reviews or guides activities of junior employees.
You Have:
<ul><li>Experience in biological or chemical sciences, life sciences, clinical studies, pharmaceutical industry regulatory affairs, quality assurance, quality control positions, clinical trials, or epidemiological research
</li><li>Experience with Micro sof t Office Tools, including Excel, Word, PowerPoint, Teams, and SharePoint
</li><li>Experience in program or project management within a scientific, engineering, or biomedical field
</li><li>Knowledge of medicinal chemistry, preclinical and clinical develop ment, including animal models, pharmacology, toxicology, and clinical operations, chemistry, microbiology, virology, and immunology
</li><li>Ability to obtain and maintain a Public Trust or Suitability/Fitness determination based on client requirements
</li><li>Bachelor&rsquo;s degree in a Biology, Chemistry, Biomedical Science, or Life Science field, such as Immunology, Molecular Biology, Biochemistry, or Microbiology, or a Physical Science field, such as Engineering, Physics, or Computer Science
</li></ul>Nice If You Have:
<ul><li>Experience in early-stage biomedical product develop ment, such as therapeutics, vaccines, diagnostics, or enabling technologies
</li><li>Experience with the health security and medical countermeasure innovation ecosystem
</li><li>Experience with U.S. government health organizations
</li><li>Knowledge of pre-clinical develop ment, such as animal models, pharmacology, or toxicology, or assay chemistry, microbiology, virology, or immunology
</li><li>Ability to pay strict attention to detail and develop technical documents and presentations
</li><li>Ability to manage multiple short- and long-term projects effectively across various stages of their lifecycle with minimal oversight
</li><li>Ability to operate independently within a fast-paced environment and maintain diligent adherence to deadlines and deliverables
</li><li>Possession of excellent verbal and written communication skills , including technical writing and editing
</li><li>Possession of excellent organization and client service skills
</li><li>Master's degree in a Biological Science, Chemical Science, Medicine, Pharmacy, Life Science, Physical Science, Biomedical Science, or Bioengineering field
</li></ul>Vetting:
 
Applicants selected will be subject to a government investigation and may need to meet eligibility requirements of the U.S. government client .
Compensation
At Booz Allen, we celebrate your contributions, provide you with opportunities and choices, and support your total well-being. Our offerings include health, life, disability, financial, and retirement benefits, as well as paid leave, professional development, tuition assistance, work-life programs, and dependent care. Our recognition awards program acknowledges employees for exceptional performance and superior demonstration of our values. Full-time and part-time employees working at least 20 hours a week on a regular basis are eligible to participate in Booz Allen&rsquo;s benefit programs. Individuals that do not meet the threshold are only eligible for select offerings, not inclusive of health benefits. We encourage you to learn more about our total benefits by visiting the Resource page on our Careers site and reviewing Our Employee Benefits page.
Salary at Booz Allen is determined by various factors, including but not limited to location, the individual&rsquo;s particular combination of education, knowledge, skills, competencies, and experience, as well as contract-specific affordability and organizational requirements. The projected compensation range for this position is $69,400.00 to $158,000.00 (annualized USD). The estimate displayed represents the typical salary range for this position and is just one component of Booz Allen&rsquo;s total compensation package for employees. This posting will close within 90 days from the Posting Date.
Identity Statement
As part of the hiring process, we will ask you to complete an identity verification process that leverages advanced biometrics and artificial intelligence to ensure authenticity and protect against identity fraud. You are expected to be on camera during interviews and assessments. We reserve the right to take your picture to verify your identity and prevent fraud.
Candidate AI Usage Policy
AI is a part of our daily work at Booz Allen, and we are committed to the responsible and ethical use of AI tools. However, we want to ensure a fair candidate process based on your own skills and knowledge. As part of this commitment, the use of artificial intelligence (AI) or other tools to assist with responses during interviews (whether in-person or virtual) is prohibited unless permission is explicitly provided .
Work Model
 
Our people-first culture prioritizes the benefits of collaboration, whether it occurs in person or virtually. To support engagement and effective communication, employees working virtually are generally expected to have their cameras on during meetings.
<ul><li>Remote : If this position is listed as remote, there may still be occasions when you are required to work in person at a Booz Allen or customer facility.
</li><li>Hybrid : If this position is listed as hybrid, you will be expected to work from a Booz Allen facility frequently, in alignment with leadership expectations and the needs of the role. You may also be required to work from or visit a customer facility.
</li><li>Onsite : If this position is listed as onsite, work will primarily be performed at a Booz Allen office or customer facility, where employees will collaborate directly with colleagues and customers as required by the role.
</li></ul>Commitment to Non-Discrimination
All qualified applicants will receive consideration for employment without regard to disability, status as a protected veteran or any other status protected by applicable federal, state, local, or international law.</div>

Medical Countermeasure Development Programmatic & Technical Advisor

Caris Life Sciences

<div>At Caris, we understand that cancer is an ugly word&mdash;a word no one wants to hear, but one that connects us all. That&rsquo;s why we&rsquo;re not just transforming cancer care&mdash;we&rsquo;re changing lives. 
We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: &ldquo;What would I do if this patient were my mom?&rdquo; That question drives everything we do. 
But our mission doesn&rsquo;t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare&mdash;driven by innovation, compassion, and purpose. 
Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.
Position Summary 
This position is responsible for equipment compliance with all applicable regulatory requirements. This role ensures adherence to Good Documentation Practices (GDP) in all paper and electronic records generated within asset lifecycle management for all managed equipment and assets. This includes assisting with the authoring and review of instrument reports, facilitation of corrections per GDP, ensuring data integrity across laboratory instrumentation records in applicable electronic platforms, and performing final quality signoff for work orders and verifications. 
 
Job Responsibilities<ul><li>
Ensure equipment verification record compliance with all applicable regulatory requirements (CLIA, NYS, CAP, ISO, FDA, IVDR, etc.).</li><li>
Collaborate and assist in clinical requalification of instrumentation to maintain company-wide regulatory compliance and operational efficiency.</li><li>
Author cross-correlation reports for Molecular, IHC and liquid profiling workflows.</li><li>
Ensure requalification paperwork is reviewed and approved in a timely fashion.</li><li>
Review records for accuracy and Good Documentation Practices (GDP).</li><li>
Analyze system/process dependencies between laboratory instrumentation, operations, IT infrastructure, and Quality to define and execute projects within the validation programs.</li><li>
Participate in internal and external audits with tasks such as audit preparation, answering questions, and providing documentation to auditors.</li><li>
Support asset lifecycle management activities.</li><li>
Author, review, revise, and implement standard operating procedures (SOPs).</li><li>
Manage company records in accordance with regulatory requirements and company policies.</li><li>
Engage in cross-functional collaborations between Systems Engineering, Laboratory, IT, Software QA, and Quality teams to support program alignment between organizational and regulatory requirements.</li></ul> 
Required Qualifications<ul><li>
Bachelor's degree in engineering, biological science, computer science, or similar field</li><li>
Strong knowledge of QMS requirements per CAP/CLIA, ISO 13485, and 21 CFR Part 820.</li><li>
One year of experience working in a regulated laboratory environment.</li><li>
Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.</li></ul> 
Preferred Qualifications<ul><li>
Lean Six Sigma certified.</li><li>
Two years of experience working in a regulated laboratory environment with a focus on laboratory instrumentation and equipment.</li><li>
Master's degree in engineering, biological science, computer science, or similar field.</li></ul> 
Physical Demands<ul><li>
Employee must be able to use standard office equipment.</li><li>
Employee must have ability to sit and stand for extended periods of time.</li><li>
Work is split between desk/cubicle environment and laboratory environment. Employee may have exposure to high noise levels, fumes, and biohazardous materials in the laboratory environment.</li></ul> 
Training<ul><li>
All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.</li></ul> 
Other<ul><li>
This position requires some evenings, weekends and/or holidays.</li></ul>
Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
This job description reflects management&rsquo;s assignment of essential functions. Nothing in this job description restricts management&rsquo;s right to assign or reassign duties and responsibilities to this job at any time. 
Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.</div>

Systems Engineering Analyst

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