We are currently searching for a Medical Advisor to provide support to the National Institutes of Health (NIH). This opportunity is a part-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.
- Review 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.
- 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
- 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
- Develop future strategic plans and educational materials for staff
- Medical Degree from an accredited university.
- Minimum 8 years of experience in medicine or clinical related field.
- Direct experience handling clinical protocols, rendering advisement on program strategy and execution, and reviewing safety reports.
- Medical document review and clinical regulatory experience, highly preferred.
Due to our contractual requirements, to be eligible for this role, you must be fully vaccinated against COVID-19 at time of hire.Company Description
We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management.
The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth.
What you’ll get…
- Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
- Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
- Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
- Discovery! With our tuition assistance and training programs, we support your career advancement.
- Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
- Support! Working parents and busy professionals – we’ve got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
- Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
- A Voice! A unique culture where you can influence decisions and have your voice heard.
We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.