30 days old

Scientific Program Manager (Regulatory) - NIH - Gaithersburg, MD

Kelly Services
Gaithersburg, MD 20898
**Scientific Program Manager (Regulatory) - NIH - Gaithersburg, MD**

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 Scientific Program Manager with Regulatory Affairs experience to work onsite with the National Institutes of Health in Gaithersburg, MD.

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

TASKS: The contractor shall:

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

+ Assists regulatory program managers with CMC-relevant responses to comments from regulatory authorities.

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

+ Ensures documentation follows FDA guidelines and Code of Federal Regulations (CFR). Interacts collaboratively with Vaccine Research Center (VRC) Office of Regulatory Sciences and Project Management groups.

+ Serves as subject matter expert for Vaccine Production Program (VPP) process development staff for raw material sourcing and product testing strategies

+ Interacts with the VRC pilot plant manufacturing, regulatory and quality assurance staff. Reviews and provides comments, recommendations, and strategy 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:

+ Bachelors degree, M.S. preferred, in life science from an accredited college or university.

+ Minimum of 8 years progressively responsible experience in Regulatory Affairs.

+ Must have at least 5 years experience with biologics/large molecules CMC preparation in the US.

+ Must have direct experience assembling Regulatory applications in eCTD format.

+ Must have demonstrated strong understanding of the U.S. Regulatory requirements.

+ Must have Expertise in MS Office suite and SharePoint.

+ Excellent oral and written communication skills.


Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at
Posted: 2019-10-14 Expires: 2019-11-18

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Scientific Program Manager (Regulatory) - NIH - Gaithersburg, MD

Kelly Services
Gaithersburg, MD 20898

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