Sr Dir, Regulatory Affairs - (R1040007) in Research Triangle Park, NC at IQVIA™

Date Posted: 9/20/2018

Job Snapshot

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Description

Line Management responsibilities for multiple Regulatory Affairs sites and/or region. Responsible for the development of regulatory business, in accordance with Global Regulatory Affairs and Corporate business plans. Participates in project-related work, as necessary.
• Elaborate integrative product development strategies for pharmaceutical products (drugs, biologics, devices) that encompass all phases of development from discovery to market, focussing primarilly on preclinical strategy and regulatory strategy.
• Assess risk and probability of success for candidate pharmaceutical products, including preparation of a gap analysis, where appropriate
• Oversee the innovative development of compounds to ensure regulatory and commercial success.
• Prepare or provide strategic guidance for nonclinical development plans as required in compliance with applicable regulatory, medical and ethics guidelines.
• Ensure high-quality, well-reasoned, objective deliverables (using data-driven design, where available and appropriate) that meet the highest standards of medical, ethical and scientific integrity and conduct.
• Propose, defend, and monitor budget requirements for product development programs.
• Propose strategies to manage and accelerate timelines for drug development strategies.
• Propose, defend and lead team members to the successful application of strategies.
• Identify, promote, and develop innovation in pharmaceutical product development.
• Assume the role of customer senior management as requested, leading customer or virtual cross functional drug development teams.
• Provide drug development expertise to support strategic business activities and investment opportunities.
• Assist in the development of programs to maximize the organization’s growth and profitability.
• Ensure Customer Satisfaction by working closely with Senior Management, CRO Operations, Therapeutic Units, and other Operations Heads to ensure optimum strategic consultancy to customers. 
• Serve as a key resource and participate in strategic business development activities including presentations to prospective clients, professional meetings or other business development activities for IQVIA Strategic Drug Development.
• Provide internal and external pharmaceutical development-related educational services in support of all branches of IQVIA business.
• Attend key scientific meetings/conferences and keep abreast of relevant scientific publications to maintain awareness of current scientific developments and progress in drug development methodology; As appropriate, represent IQVIA or the partner in such meetings.
• Develop and maintain ongoing relationships with pharmaceutical and biotechnology companies, key opinion leaders; identify new business opportunities.
• Provide due diligence scientific, regulatory, and drug development expertise and activities for IQVIA or IQVIA customers.
• Compliance with all business office requirements for tracking of time and effort..

Job Requirements


REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Possess demonstrated working knowledge of corresponding professional grade level responsibilities, skills and abilities, as required for meeting regional or global objectives.
Strong, proven leadership skills and the ability to work effectively with senior management and delivers positive messages to staff
Ability to make difficult judgment calls within sphere of responsibility. Demonstrates advanced negotiating, influencing and motivating skills, with the ability to identify and resolve issues at a senior level within Quintiles and customer organization
Act as a role model for professionalism and a respected ambassador for the Regulatory Business Unit, remaining effective in difficult, stressful and/or highly sensitive situations
Ability to communicate effectively at all levels in the organization, consistently demonstrating confidence and authority within remit
Sound financial awareness
Strong software and computer skills, including MS Office applications
MINIMUM REQUIRED EDUCATION AND EXPERIENCE Degree in life science-related discipline or professional equivalent* plus at least 12 years regulatory experience including 8 years management experience (*or a combination of education, training and experience)

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there! 

We invite you to join IQVIA™.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.


Job ID: R1040007