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Medical Officer

Employer
Medical Science & Computing (MSC), a Dovel company
Location
Rockville, Maryland
Start date
Nov 21, 2021

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Discipline
Clinical, Clinical Medicine, Medical Affairs
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
BioCapital

We are currently searching for a Medical Officer 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 Rockville, MD.

 

Duties & Responsibilities
  • Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of COVID-19 and/or related co-morbidities. This includes evaluating the hypothesis, objectives, study design, feasibility, and regulatory requirements, as well as identifying medical and logistical problems that may impede a study.
  • Work with the protocol team, network leadership, PPD leadership and other trial stakeholders to address issues and problems in a timely manner.
  • Advise program management of merits and deficiencies in proposed clinical studies.
  • Lead special projects and initiatives in support of the studies in the program portfolio. Set objectives and project plans and ensure delivery.
  • Provide clinical expertise to assist in developing Investigational New Drug (IND) applications. Individuals providing this expertise will be named as reviewer of information relevant to the safety of the drug in question, on line 15 and 16 of the IND application (FDA Form 1571).
  • Evaluate annual IND annual reports and other trial related reports for medical safety and general study performance.
  • Provide clinical and scientific information for preparing program communications to the Food and Drug Administration (FDA), other government and nongovernmental agencies, pharmaceutical companies and Data Safety Monitoring Boards.
  • Conduct site visits, when necessary, to obtain additional data and information for use by federal staff, in the consideration and evaluation of ongoing and future programs.
  • Review serious adverse event (SAE) reports, provides expert medical advice for potential impact of SAEs in ongoing research and participate in the preparation of reports submitted to the FDA.

#LI-SK1

Requirements
  • MD degree in a related field is required.
  • Minimum of two (2) years of experience working directly in a clinical/medical setting.
  • Demonstrates experience with medical research, preferably involving, clinical development investigations.
  • Experience working with COVID-19 treatment and prevention studies, useful.
  • Experience evaluating adverse events and presenting research and investigational findings to peers, senior level officials, the FDA, Data Safety Monitoring Boards, pharmaceutical companies, and other government and non-government agencies.
  • Experience assisting in the development of Investigational New Drug (IND) applications.

#LI-SK1

  • 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.
Company Description

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) were 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 

 

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.

 

 

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