Medical Officer Jobs

Medical Officer

Remote – US

The Emmes Company, LLC (“Emmes”) is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience, we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our “Character Achieves Results” culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships, and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients’ success by sharing ideas openly and honestly.

Job Summary

The Medical Officer has functional responsibility for clinical safety and pharmacovigilance, medical consulting, and reviewing activities, including protocol development activities and practical aspects of clinical trial safety monitoring.

Key Accountabilities/Duties/Responsibilities

• Works directly with the Medical Director and Chief Medical Officer in managing both

corporate and project-related activities; at the project level, will function in the role of a

Medical Monitor leading the clinical trial safety monitoring for the assigned protocols

• Manage Safety Monitors to implement safety management activities and achieve
• Provides safety oversight throughout the lifecycle of the clinical study including evaluation, assessment, and monitoring of safety events and protocol deviations

project objectives

• Reviews IND/IDE safety reports (MedWatch safety reports (FDA Form 3500A), Council
• Evaluates adverse events and serious adverse events (SAE) including expedited reporting
• Review SAE narratives and other safety reports

for International Organizations of Medical Sciences (CIOMS) safety reports, and

Development Safety Update Reports (DSUR), and other aggregate reports as applicable)

• Reviews and approves Medical Dictionary for Regulatory Activities (MedDRA) and

WHO Drug coding

• Reviews the FDA MedWatch Alerts and safety communications and recommends

action for implementation by study teams, as applicable

• Provides medical input on safety considerations during development of protocol and

associated documents.

• Advises study sponsor and study team on protocol development, inclusion/exclusion

criteria, eligibility questions, protocol study design and halting rules, etc.

• Ensures the medical and scientific quality of documents such as clinical trial protocols,

investigator’s brochure, informed consent document, patient diaries, and case report

forms

• Works directly with project-level staff to develop appropriate pharmacovigilance

documents and project plans (Safety Monitoring Plan, Communication Plan, and

Training Plan)

• Supports preparation of safety section of clinical trial reports like annual reports and

clinical study reports

• Engages with safety oversight committees (SOC) and consults with sponsors, investigators, and pharmaceutical partners
• Participates in safety oversight committee meetings (DSMB/DMC/SMC); answers

questions about safety monitoring and related procedures (e.g., review of halting

rules)

• Participates in regulatory (FDA or other) meetings and scientific review meetings
• Interacts with pharmaceutical companies and other study partners
• Other duties as assigned
• Participates 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
• Reviews SOC Charter, safety reports, and meeting minutes
• Participates in sponsor meetings and investigator training meetings
• Other corporate activities include annual SOP reviews, development and teaching of Emmes internal classes, participation in corporate safety meetings/activities, and other corporate CSP activities

Required Education and Experience

• Medical Doctor degree (MD, MBBS, MBBCh, or other equivalent) is required
• Direct work experience with regulatory and pharmacovigilance activities or documented Training
• Demonstrated clinical medicine expertise through practice experience preferred
• 7-8 years of experience and in CRO and/or Biopharmaceutical
• Excellent clinical judgement and ability to communicate complex clinical issues in a

scientifically sound and understandable way

• Ability to direct activities and encourage positive team-based culture
• Collaboration: Contributes outstanding teamwork in the achievement of group and
• Excellent verbal and written communication skills
• Capacity to provide leadership and creativity in the work environment
• Expertise in medical monitoring and serious adverse event reporting
• Demonstrated experience with or training in clinical trial data collection
• Ability to work as a team member and function on a cross-functional team
• Experience working with regulatory submissions

corporate goals

• Initiative: Exhibits resourcefulness and action in making independent sound decisions
• Service-Oriented: Provides inspired service to internal/external clients that goes beyond
• Results-Oriented: Performs beyond current job to meet critical deadlines and deliverables

the expected

• Responsibility: Takes ownership of a situation and significantly improves processes and/or service
• May travel between corporate locations; and travel as needed by projects

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

· Unlimited Approved Leave · Tuition Reimbursement · 401k Retirement Plan

· Work From Home Anywhere in the US · Maternal/Paternal Leave

· Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - The Emmes Company, LLC

The Emmes Company, LLC 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.