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.â¯â¯
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.
What You’ll Bring:
15 years of pharmaceutical / Contract Research Organization (CRO), drug development, Regulatory experience, with progressive management responsibilities.â¯
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
Why CTI?
Advance Your Career – We invest in your professional growth. Through a structured mentoring program, leadership development courses, and access to ongoing education and training opportunities, including tuition reimbursement, you’ll have the tools to achieve your goals. Our dedicated training department supports your successful career at CTI.
Be Part of an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with generous health benefits, vacation packages, hybrid work opportunities, and paid parental leave. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.
Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.
Important NoteIn light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page. Please Note
We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any point during the recruitment process
Equal Opportunity Employer/Veterans/Disabled
Numbers & Facts
Location
Covington, Kentucky
Skills
Adverse Eventsunmatched
Budget Managementunmatched
Budgetingunmatched
Business Developmentunmatched
Business Planunmatched
Career Counselingunmatched
Case Report Form (CRF)unmatched
Chronic Diseaseunmatched
Clinical Practices/Protocolsunmatched
Clinical Researchunmatched
Clinical Trialunmatched
Computer Telephony Integration (CTI)unmatched
Contract Research Organization (CRO)unmatched
Customer Satisfactionunmatched
Drug Developmentunmatched
Exceeded Sales Goalunmatched
FDA (Food and Drug Administration)unmatched
GCP (Good Clinical Practices)unmatched
International Businessunmatched
International Healthunmatched
Leadershipunmatched
Marketing Softwareunmatched
Medical Affairsunmatched
Medical Ethicsunmatched
Medicineunmatched
Mentoringunmatched
Microsoft Product Familyunmatched
Pharmacovigilanceunmatched
Presentation/Verbal Skillsunmatched
Project Trackingunmatched
Regulationsunmatched
Regulatory Submissionsunmatched
Safety/Work Safetyunmatched
Short Messaging Service (SMS)unmatched
Standard Operating Procedures (SOP)unmatched
Strategic Analysisunmatched
Strategic Planningunmatched
Team Lead/Managerunmatched
Training Program Developmentunmatched
Tuition Reimbursementunmatched
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