Senior Scientific Program Manager

Location
Bethesda, Maryland
Posted
Jan 03, 2022
Ref
2021-11103
Hotbed
BioCapital
Required Education
Doctorate/PHD/MD
Position Type
Full time

We are currently searching for a Senior Scientific Program Manager to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Gaithersburg, MD.

 

Duties & Responsibilities
  • Provide regulatory expertise and strategies for investigational biologics including early development, production and pre-clinical in vivo studies for a successful IND submission or equivalent approach for trials planned outside the US.
  • Evaluate and propose appropriate toxicity studies and models for products intended to be studied as vaccines.
  • Prepare Chemistry, Manufacturing and Controls (CMC) and Non-clinical study sections for regulatory submissions by acting as the scientific writer from available source documents.
  • Communicate with the FDA for submissions/meeting requests and lead meetings with the Food and Drug Administration.
  • Coordinate with Quality and Technical team members for health regulatory compliance.
  • Provide regulatory advice and recommendations to the Project Lead for manufacturing projects and pre-clinical studies.
  • Assist the team with impact/risk assessment from issues, failures, and deviations during manufacturing and pre-clinical studies.
  • Prepare technical reports, updates, and summaries for internal meetings with Division Management.
  • Perform site-visits of CMOs at kick-off or during critical project execution stages or for troubleshooting as requested by the POC.

 

Requirements
  • Ph.D. degree and at least ten (10) years of experience is required.
  • Knowledge of U.S. FDA regulations and guidelines, ICH Guidelines, International Health Regulations and their application to biologics. Experience working at the U.S. FDA is preferred.
  • Regulatory Affairs Certification is preferred.

#LI-GH1

Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace.

#LI-SK1

Company Description

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) was acquired in October 2021.

 

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

 

Guidehouse is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.

 

Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance, including the Fair Chance Ordinance of Los Angeles and San Francisco.

 

If you have visited our website for information about employment opportunities or to apply for a position, and you require accommodation, please contact Guidehouse Recruiting at 1-571-633-1711 or via email at RecruitingAccommodation@guidehouse.com. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.

 

Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse, and Guidehouse will not be obligated to pay a placement fee.