Assoc Dir, SSU Regulatory

Description

Associate Director, Site Start-Up & Regulatory

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities

• May oversees people management activities including interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling.
• Ability to mentor and coach managers and supports team managers on all administrative or departmental activities.
• Facilitates processes, resourcing, and communications within a department, across departments, or within the country assigned. Acts as liaison and facilitator between customer leaders and senior management for related tasks and/or issues. Plans and negotiates resources with line management of functional areas. Serves as a departmental point of escalation for internal and external customers.
• May be responsible & accountable for the effective operations and SSU project deliverables across all regions, within the assigned programs/projects.
• May develops and maintains strategic relationships with customers. Collaborates with business leads for business development, alliance management, contracts and proposals development, project management, clinical management, operational personnel, and executive management to achieve project goals. Ensures that individual project targets are met, clients are satisfied, services are provided with the highest quality standards and policies and procedures are followed.
• May supports management with site start-up and financial management tasks of projects, as well as strategy development for process improvement. Facilitates and supports project reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis. Supports reporting of department and team metrics/cycle times and strategies to improve metrics/cycle times Guarantees SSU delivery of assigned projects and/or initiatives.
• Involved in reviewing, approving, and presenting prepared information at project or departmental review meetings. Develops and implements training programs for appropriate departmental teams.
• Interacts with internal or external Legal Departments and assists with the accurate creation and implementation of contract management workflows or with the contract management group. Identifies and reports on areas of process and contract risk.
• Oversees the implementation of customer-required and/or enterprise-wide project management systems and tools. Participates in the development, implementation, and maintenance of enterprise project management systems, acting as a systems manager; may supervise a systems administrator.
• 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 larger teams of subject matter experts in the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes. Develops and implements strategies and tools for tracking contract management team metrics/cycle times.
• Responsible for creating a 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.

Qualifications

What we're looking for

• Bachelor's Degree
• Experience in managing teams of clinical research employees
• Strong leadership skills: ability to teach/mentor team members
• Ability to coach employees to reach performance objectives
• Ability to recognize and take appropriate action when employee performance is not acceptable
• Extensive Clinical Trial experience
• Sales experience preferred.
• Strong knowledge of clinical research management processes.
• Understanding of the needs of countries and the ability to work across geographic regions.
• Strong CRO operational experience with a track record in project management working in an international or global capacity.
• Thorough knowledge of applicable regulations, drug development, and clinical project management procedures.
• Strong presentation, documentation, and interpersonal skills.
• Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet.
• Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.

The annual base salary for this position ranges from $97,000 to $170,000. At Syneos Health, it is not typical for a candidate to be hired near the minimum or maximum of the pay range. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information:
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.