Medical Officer

Location
Rockville, Maryland
Posted
Jun 23, 2022
Ref
2021-10638
Hotbed
BioCapital
Required Education
Masters Degree/MBA
Position Type
Full time

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
  • Evaluate existing protocols and provide suggestions for design, execution and improvement.
  • Provide guidance to staff on various clinical processes and operational issues.
  • Reviews safety reports and provides assessment of clinical implications of findings.
  • Develop policies and guidelines.
  • Coordinate and participate in various meetings, training and safety-related educational programs.
  • Perform Medical Review Activities including:
    • Study documents: participate in drafting protocols and ICFs, draft shell tables, training materials, monitoring reports for clinical aspects and adherence to protocol.
    • Clinical data: tables, listings, figures, narratives, draft reports, summaries of efficacy, safety, benefit risk, regulatory responses, publications, press releases.
    • Compliance: review responses to audit findings, protocol deviations and violations; draft and review SOPs.
    • Draft and review position papers: on disease under study, competitive intelligence on ongoing studies and therapies, literature searches.
  • Perform Team Activities (lead or participate, as needed) including:
  • Protocol meetings
  • Organizational and team building activities
  • Training on clinical and safety components of protocol
  • Presentations on strategy, protocol, data, and progress to team(s), management, study sites
  • Define/clarify roles and responsibilities, review enrollment strategies, country and site selection, speed of activation, site training, assessment of non-enrolling sites, scrutiny of high enrolling sites
  • Involvement in Strategy and Organization including:
    • Regulatory: strategy, submissions, writing, document review, responses
    • Communications: assist in creation/management of clinical website, media materials, press releases, communications to study staff
  • Clinical liaison for studies with other divisions and programs
  • General: coordination and chairing of workshops, expert meetings.
  • Developing future strategic plans and educational materials for staff.

       #LI-DW1

Requirements
  • Medical degree in a related field, required.
  • Minimum eight (8) years of experience; inclusive of clinical trials and working with infectious diseases.
  • Experience working with clinical protocols and safety components.
  • Experience performing medical reviews; drafting protocols & reports.

 

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.