What You'll Do:- 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.
What You'll Bring:- 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
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
