Principal, ICO (Regulatory Affairs)

Principal, ICO

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

We are looking for passionate, resilient, and inspiring individuals to join our team. As the Principal, ICO you will be responsible for leading the regulatory strategy to support registration (new and maintenance) in the respective regions of drugs, biologics, and medical devices. You will be responsible for the strategic approach for securing new business, facilitating issue resolution, ensuring project / program timelines, and budgets.

The role

• Directs team on data gathering efforts. Selects deliverables, tools & techniques to be applied by the team to conduct the analysis. Learns and draws on new analytic approaches
• Leads the scientific development and validation of scientific research methodology in order to meet the objectives of the research study
• Acts as scientific thought partner with the client and the project team throughout the projects
• Provides scientific and methodological leadership on a range of project types within the practice and makes significant contributions to internal and client discussions
• Reviews and approves final drafts of project deliverables (e.g., protocols, analysis plans, reports) to ensure they are of a high standard suitable for release to the client
• Reviews and approves methodological and strategic components of proposals for Subject Matter Expertise area
• Conceptualizes and drafts, or leads, a complete proposal based on a client idea or RFP.
• Acts as scientific thought partner with the client and the project team throughout the project
• Initiates and nurtures client relationships and maintains contacts to build reputation and deal flow
• Key account lead for a combination of current and prospective clients
• Independently develops project plans and scientific content in proposals and achieves good conversion rate of submitted and won proposals
• Represents Service Line at internal and external meetings and strategy review presentations/overviews
• Maintains positive client contact, serves as escalation path for unresolved issues as necessary, and initiates client dialogue and updates on project progress
• Regularly contributes to industry thought leadership.
• Takes ownership of final budget, deliverable and project timeline; identifies scope expansion and need for amendments; serves as consultant to other principal investigators or staff on other projects
• Organizes and monitors workloads in line with budget and time to ensure project efficiency and quality of insight
• Anticipates key project risks. Proactively develops and executes mitigating strategies effectively as required

What you need

• Minimum of a BS degree in life sciences, advanced degree preferred
• RAC Certification preferred
• Minimum of 10 years of related experience providing regulatory strategy
• Working knowledge of local and global Health Authority regulations
• Effective Project Management skills
• Knowledge of business development

Why join us?

Ongoing development is vital to us, and as a Principal, ICO you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin

#LI-SB1