Job Purpose / Summary: The Assistant Director of Regulatory and Scientific Affairs is responsible for providing scientific and regulatory expertise to assigned Regulatory and Scientific Affairs projects; and is able to implement multiple projects, including managing direct interactions with clients; includes providing substantive input to all phases of regulatory and scientific projects in accordance with all applicable CTI Standard Operating Procedures (SOPs).
What You'll Do
Participates on assigned Consulting projects based upon scope and need; leads project teams as appropriate.
Serves as scientific / regulatory resource for team members and clients.
Conducts scientific research and assimilates data into written deliverable products for clients, including clinical study protocols, clinical study reports (CSRs), and other documents intended for submission to regulatory authorities, training materials, and written summaries.
Participates in drug development projects, including strategic development plans, Pre-investigational new drug (IND), IND, new drug application (NDA), biologics license application (BLA), and other regulatory documents.
Interacts professionally with clients and thought-leaders to understand their objectives and meet their needs.
Participates in Business Development (BD) capabilities presentations, client visits, and programs as needed.
Collaborates with Medical Directors, Biostatistics and Programming, Clinical Operations, and other disciplines as appropriate.
Relies on experience and judgment to plan and accomplish goals; performs variety of complicated tasks with high degree of skill and flexibility.
Prioritizes and manages time effectively to meet the needs of multiple clients simultaneously.
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)
We are looking toward the future – We have had a consistent 15% growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate
Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market
What You'll Bring
PhD / DrPH, MD, or PharmD preferred; MS / MPH, BS / Nurse Practitioner / BSN / MSN with relevant experience
Seven years of direct prior relevant pharmaceutical / contract research organization (CRO) drug development, regulatory, or medical writing experience
Experience in preparing technically complex documents intended for submission to regulatory authorities (eg, briefing documents, CSRs)
Demonstrated excellent research and technical writing skills
Internal Number: 127
About CTI Clinical Trial and Consulting Services, Inc.
WHERE LIFE-CHANGING THERAPIES TURN FIRST™
CTI is an innovative, international drug and device development organization that delivers a full spectrum of clinical trial and consulting services from bench to commercialization.