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Job description
Responsibilities
Lead global Medical Affairs and RSA teams with clarity of vision and purpose.
Develop and maintain departmental global business plans.
Meet or exceed department sales and revenue objectives.
Participate in Business Development (BD) capabilities presentations, prepare for and attend client visits and programs.
Build high performance teams within each of the functions. Develop, update, and counsel team members on career development and advancement.
Ensure all projects are completed according to contractual agreements (budget, timelines and deliverables) and CTI SOPs.
Develop and assess strategies to drive client satisfaction.
Oversee the development of SOPs.
Oversee and review processes for deliverables, responsible for quality oversight of all project deliverables.
Develop and oversee Medical Monitoring Plans.
Ensure the safety of all patients in clinical trials and ensure clinical trials are conducted according to ethical standards in medicine, providing medical, clinical development and regulatory input.
Review and manage all serious adverse events (SAE) during the course of the clinical trials, in collaboration with Safety Department.
Collaborate with global teams throughout the regulatory submission and approval process.
Provide leadership for scientific writing projects, collaborating with team members to ensure medical accuracy.
Participate in advisory boards, training programs, and development and review of scientific writing projects.
Oversee medical review of the protocol, Investigative Drug Brochure (IDB), Case Report Forms (CRFs), Clinical Study Report (CSR), patient narratives and other high-profile documents, such as marketing applications, clinical safety/efficacy summaries and overviews.
Develop and manage department budgets.
Qualifications
15 years of pharmaceutical / Contract Research Organization (CRO), drug development, regulatory experience, with progressive management responsibilities.
Scientific, regulatory, clinical trial or drug development experience.
Thorough knowledge of relevant FDA and other international health authorities’ regulations and guidelines, including directly interacting with such authorities, and GCP and ICH guidelines.
Master’s, PhD, or MD.
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Worksite address
covington, KY, 41011, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.