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Medical Director – Clinical Trial Physician, Rheumatology

Medical DirectorMedical DirectorFull TimeRemoteTeam 10,001+Since 1956H1B SponsorCompany Site LinkedIn

Location

North Carolina

Posted

28 days ago

Salary

Not specified

Postgraduate Degree1 yr expEnglishGoogle Cloud Platform

Job Description

• Provides clear medical leadership in the Study team • working in close collaboration with the other members of this cross functional team • Provide medical leadership to the study teams, including creating clinical trial protocols • contribute to site selection • review and approval of study protocols and amendments • Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions • ensure medical validity of each individual primary endpoint as well study subject safety • Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP • Collaborate with the cross functional study team members

Job Requirements

Medical Doctor or equivalent degree required
Board certification(s) are preferred
Specialty education(e.g. residency/fellowship) required in rheumatology
This should be accompanied by patient treatment and/or research experience
1-3 years of industry experience preferred
Experience should be in clinical development in a Pharmaceutical, Biotech or CRO organization
Excellent English, both written and spoken is a must
Shown understanding and experience with NDA submission process
Shown understanding of regulatory guidelines for adverse event reporting
Proven interpersonal skills enabling to lead a study team
Pro-active problem solver with negotiation skills
Strong communication skills

Benefits

competitive remuneration
annual incentive plan bonus
healthcare
range of employee benefits

Related Categories

Medical Director

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