19003791
Associate Director, SSU & Regulatory (Regulatory Core Compilation)

Home based or office based Anywhere in Europe
  At Syneos Health we appreciate the importance of having experts dedicated to the set up stages of the studies, and for this reason we have a devoted Study Start Up team with departments focused upon Site Identification and Feasibility, Site Contracts, Ethics and Regulatory, Project Delivery, TMF and Patient Recruitment.

As a member of our Study Start Up team you will traverse all therapeutic areas and phases, providing your expertise at this vital period of time in the study. This expertise at this critical time has resulted in the average study start up time four weeks faster than industry standard.

Purpose: Supports Site Start-Up (SSU) for the customer focused deliverables within a region or globally within the assigned projects or programs. Performs assigned activities within the SSU Core Compilation Team that support SSU activities as needed for studies considered as medium to high in complexity but in all phases of clinical trials related to investigational drugs, biologicals, gene-modified organisms and medical devices as required.

Key Responsibilities:
• Ensures fulfillment of customer requirements and compliance with related regulations.
• Analyzes processes and develops strategies to increase efficiency.
• Performs operational planning at the department or business unit level, including efficient allocation of resources within the Regulatory Core Compilation Team
• Functional Profit/Loss (P/L) responsibility for assigned projects, programs, and/or a portfolio of work.
• Supports business development selling efforts and may directly represent the Company in functional service opportunities.
• Develops requirements for modifications to existing systems, metrics and reports based on input from functional teams. Provides input and requirements for long-range IT plans. Implements Company and/or customer-required project management systems and processes.
• Leads team of regulatory subject matter experts in study development and Standard Operating Procedures (SOPs) /Work Instructions (WI) to support new or existing processes and/or regulation.
• Responsible for creating a regulatory study predictable project experience for both employees and clients alike.
• Contributes to and may lead change initiatives across the SSU and Regulatory department.
• Develops and implements strategies and tools for tracking metrics/cycle times. Oversees all quality control efforts of individual departmental teams.
• Represents the Company at professional meetings or seminars.
• Establishes and maintains training materials for assigned area.

To succeed in this role you will need the following skills/experience:

• Bachelor’s Degree
• Strong leadership skills; ability to teach/mentor team members
• VHP experience required.
• Strong knowledge of clinical research management processes.  • Strong global regulatory background with thorough knowledge of applicable regulations, drug development, and clinical project management procedures. 

• Strong CRO operational experience with a track record in project management working in an international or global capacity.
• Strong presentation, documentation, and interpersonal skills.
• Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.  

What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.  

Why Syneos Health?
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.  

#LA1  

Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.