Scientific Program Manager (Regulatory Affairs & CMC Preparation) - NIH

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Job description

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 the leading medical research center in the world. We are seeking an experienced individual to work as a Scientific Program Manager - (Regulatory Affairs/Biologics and Vaccine CMC Preparation) at the National Institutes of Health in Gaithersburg, MD.

This is a long-term contract position which offers:

- Competitive compensation and comprehensive benefit package

- Optional health, vision, and dental plans

- Vacation leave as well as paid federal holidays and 401K plan.

- Access to NIH's unparalleled resources and niche scientific initiatives

TASKS/SERVICES. The contractor shall:

(1) Responsible for chemistry, manufacturing and controls (CMC) information of all investigational new drug (IND) applications for vaccines, monoclonal antibodies, and related biological products.

(2) Assist regulatory program managers with CMC-relevant responses to comments from regulatory authorities.

(3) Oversee planning, preparation and review of Module 3 sections in Common Technical Document (CTD) format for submission to regulatory authorities.

(4) Ensure documentation follows FDA guidelines and Code of Federal Regulations (CFR).

(5) Interact collaboratively with VRC Office of Regulatory Sciences and Project Management groups.

(6) Serve as a subject matter expert for Vaccine Production Program (VPP) process development staff for raw material sourcing and product testing strategies.

(7) Interact with the VRC's pilot plant manufacturing, regulatory and quality assurance staff.

(8) Review and provide comments, recommendations, and strategies on product specifications, stability protocols, comparability protocols and reports, investigator brochures and other related CMC documents during product development of biological products for early phase clinical trials.

REQUIREMENTS. The contractor must have:

(1) Bachelor's degree in biology, life science or related discipline; master's degree preferred

(2) Minimum of 6 years of related experience with progressively responsible experience in regulatory affairs.

(3) Minimum of 5 years working experience with biologics or vaccines CMC preparation in the US.

(4) Direct experience assembling regulatory applications in eCTD format.

(5) Demonstrated strong understanding of the U.S. regulatory requirements.

(6) Excellent organizational and communication skills.

(7) Expertise in MS Office and SharePoint.

Please Note: Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.

PLEASE APPLY ONLINE

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 aren't 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, Kelly's Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover what's 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.

**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. It's just another way we make the job search work for you.

**You should know:** Vaccination against COVID-19 is a requirement for all job opportunities offered through Kelly Government Solutions, in accordance with the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors.

**About Kelly** **®**

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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. ()