Description

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

Why CTI?

• We support career progression - 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward
• We value education and training - We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
• We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade
• Our culture is unparalleled - Click here to learn more about "The CTI Way"
• We think globally and act locally - We have a global philanthropic program supporting our team's efforts to improve their local communities (Click here to learn more about our "CTI Cares" program)

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