The Emmes Company, LLC ("Emmes") is searching for a Medical Officer
. Emmes has offices located at the below locations and throughout the greater Washington, DC area with flexibility for office location preference, dependent upon position.
Emmes, established in 1977, is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.
Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We provide statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Purpose
The Medical Officer position has functional responsibility for pharmacovigilance (PV), medical consulting and review activities including protocol development activities and practical aspects of clinical trial safety monitoring. Responsibilities
- Managing corporate and project related activities for existing and forecasted business
- Participate in key business development initiatives including developing independent PV services in addition to technical medical inputs for proposals, client meetings and bid defense presentations
- Ensure alignment of strategy and execution of projects by working closely with project leadership
- Manage safety oversight throughout the life cycle of the clinical study including evaluation, assessment and monitoring of safety events and protocol deviations
- Evaluate adverse events and serious adverse events (SAE) including expedited reporting.
- Review SAE narratives and other safety reports
- Review IND/IDE safety reports (MedWatch safety reports (FDA Form 3500A), Council for International Organizations of Medical Sciences (CIOMS) safety reports, and Development Safety Update Reports (DSUR), as applicable.
- Review processes and procedures for Medical Dictionary for Regulatory Activities (MedDRA) and WHO Drug coding
- Review the FDA MedWatch Alerts and safety communications and recommend action for implementation by Emmes, as applicable
- Provide medical input on safety considerations during development of protocol and associated documents
- Advise Study sponsor and study team on protocol development, inclusion/exclusion criteria, and eligibility questions, protocol study design and halting rules, etc
- Ensure the medical and scientific quality of documents such as clinical trial protocols, investigator's brochure, informed consent document, patient diaries, and case report forms
- Work directly with project level staff to develop appropriate pharmacovigilance documents and project plans (Safety Monitoring Plan, Communication Plan and Training Plan)
- Support review of safety section of clinical trial reports like annual reports and clinical study reports
- Engage with safety oversight committees (SOC), and consult with sponsors, investigators and pharmaceutical partners
- Participate in safety oversight committee meetings (DSMB/DMC/SMC); answering questions about safety monitoring and related procedures (e.g., review of halting rules)
- Review SOC Charter, safety reports, and meeting minutes
- Participate in Sponsor meetings, and investigator training meetings
- Participate in regulatory (FDA or other) meetings and scientific review meetings
- Interact with Pharmaceutical companies and other study partners
- Participate in corporate process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, SOP development, participation in internal and external audits, and professional development activities
- Other corporate activities include annual SOP reviews, development and teaching internal Emmes training classes, participation in corporate safety meetings/activities; and other corporate PV activities
- Other duties as assigned
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- Medical Doctor degree (MD, MBBS, MBBCh, or other equivalent) is required for the position
- Minimum 3-5 years' total experience consisting of the following:
- Minimum two years' experience obtained in a clinical medical setting with demonstrated clinical medicine expertise through practice experience
- Minimum one year of pharmacovigilance experience and/or clinical trial experience, preferably in a CRO
- Prior clinical trials experience desired
- Expertise in medical monitoring and serious adverse event reporting
- Demonstrated working knowledge through experience or training in GCPs
- Demonstrated experience with, or training in, clinical trial data collection and medical monitoring
- FDA or regulatory experience desired
- Prior experience in Hematology, Oncology, Infectious Diseases, Opthalmology and/or Neurology desired
- Ability to maintain a high degree of integrity and utilize strong interpersonal skills to carry out positive interactions with internal and external contacts
- Excellent verbal and written communication skills
- Ability to travel up to 25% United States and international, post COVID-19 pandemic travel restrictions being lifted
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Emmes is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.