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27 days old

Regulatory Affairs Specialist

Kelly Services
Bethesda, MD 20814
Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers.? Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world.? We are currently seeking a Clinical Biostatistician (Data Analysis) with the National Institutes of Health in Bethesda, Maryland.


This is a long-term contract position which offers:

- Competitive salary with comprehensive benefit package

- Opportunity to work at NIH, the world's foremost medical research center

- Learn more about what Kelly can do for you at www.kellygovernmentsolutions.com


The purpose of this position is to provide expert regulatory support to the

institute, specific to institute's responsibilities as Sponsor. Responsibilities

include:

working with investigators and study teams

ensuring adequate records of the investigational drug/device and

that the records are maintained, per FDA regulation

monitoring the progress of the studies

ensuring that the study is conducted in accordance with the

protocol

obtaining and maintaining investigator financial disclosure

information

reviewing and evaluating the safety and effectiveness of the

drug/device

determining when safety events should be reported to the FDA

making submissions, as applicable, to the FDA in electronic

format




TASKS. The contractor shall:


+ Assists researchers and medical staffs prepare clinical trial, pharmaceutical and medical device regulatory documentation.

+ Assist primary investigators and clinical supervisors obtain and maintain government approval for drugs, medical devices, nutritional products and related healthcare materials.

+ Collaborate with primary investigators or project teams to ensure awareness of and compliance with all manner of government regulation.

+ Prepare documentation, manage information, and maintain files and data repositories securely and in accordance with regulatory standards.

+ Assist editors draft product and procedure language for regulatory accuracy and completeness.

+ Review marketing and promotional materials, labels, batch records, specification sheets and test methodologies for compliance with applicable regulations and policies.

+ Document regulatory compliance actions and track progress against predetermined project plans and schedules.

+ Develop and maintain internal regulatory and compliance library for reference by research and medical staffs.

+ Collect, gather, compile, and create templates for materials needed for registration and submission to regulatory agencies.

+ Develop and maintain communication with regulatory agencies regarding pre-submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions still under review.

+ Serves as subject matter expert on regulatory and compliance issues and assists researchers and medical staff track compliance.

+ Conduct routine research to identify emerging regulatory requirements and prepare programs to adjust to new compliance standards.

+ Perform advanced research and policy analysis of regulatory and compliance articles and issues to ensure clinic and program compliance programs are up to date.

+ Develop and distribute internally variety of job aids, specifications and training materials to explain regulations and policies and instruct staff on preparation of compliance documentation.

+ Evaluate applicable laws and regulations and determine those applicable to variety of programs, clinics and trials and inform staffs.

+ Contributes to development and maintenance of clinic and program policies, standard operating procedures and guidelines.

+ Develop regulatory and compliance specific standard operating procedures and provide workforce instruction and compliance assistance.

+ Participate in variety of cross-organizational working groups to increase awareness and efficiency of implementing new and emerging regulatory requirements.

+ Designs and coordinates internal compliance reviews.

+ Coordinates with other regulatory affairs specialists to share information and design cross functional plans for improving regulatory and compliance performance.


+ Assist in the creation of clinical trial protocols for NIH, including parallel-arm, crossover, and adaptive designs.

+ Track document modifications, errors and changes to all databases and decisions.

+ Independently perform a variety of data management and analytical tasks, including data reduction techniques.


+ Apply and/or learn new statistical methods and software packages and provide consultation and training to other analysts and staff.


+ Use a range of standard and non-standard statistical software packages for projects and translate among the most common packages including R, SPSS, and SAS.

+ Communicate the details of statistical analyses and results in a clear and understandable manner.


+ Review and summarize relevant literature and other sources to develop analytical plans.


REQUIREMENTS. The contractor must have:


* Master's (Bachelor's and 3 years of experience is equivalent to MS)

* Certifications & Licenses

- Regulatory Affairs Certification (Preferably)

* Field of Study

- Biochemical Sciences - Biology - Miscellaneous Biology -

Pharmacology - Nursing - Pharmacy Pharmaceutical Sciences & Administration

* Skills

- project management skills - exceptional verbal and written

communication skills - familiar with databases

* Software

- eCTD and WebTrader


Work Location: Bethesda, MD 20817


When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position.




Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you arent contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.


As a specialty talent company, Kelly is committed to doing the right thing for our talent and clients. We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kellys Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover whats next.


It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. Its just another way we make the job search work for you.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

Categories

Posted: 2022-07-15 Expires: 2022-08-15

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Regulatory Affairs Specialist

Kelly Services
Bethesda, MD 20814

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