Assoc Dir, SSU Regulatory (Program Lead)
Company: INC Research Inc
Posted on: June 6, 2021
Associate Director, Site Start-Up & Regulatory
Come discover what our 25,000 employees already know: work here
matters everywhere. We're a growing and evolving biopharmaceutical
industry leader, which means you'll have endless opportunities to
work with experts around the world and build the career you've
As a part of the Syneos Health team, you'll help us deliver
results for a rewarding reason - we improve patients' lives around
the world. Because to us, a patient isn't just a number, they're
our family, friends, and neighbors.
Why Syneos Health
- #SyneosHealthLife means we're committed to our Total Self
culture - where everyone can authentically be themselves. Our Total
Self culture is what unites us globally, and we know every person's
unique contributions make a difference.
- We believe our success is a direct result of the people who are
driving it - you! We value your dedication to care for our
customers and patients, so we want to focus on taking care of you.
That's why we offer a comprehensive benefits program encompassing
your total health - physical, mental and financial.
- 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.
- May oversees people management activities including
interviewing and selection, terminations, professional development,
performance appraisals, job description preparation, and employee
- 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
- May be responsible & accountable for the effective operations
and SSU project deliverables across all regions, within the
- 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
- 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
- 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
- Establishes and maintains training materials for assigned
What we're looking for
- Bachelor's Degree
- Experience in managing teams of clinical research
- Strong leadership skills; ability to teach/mentor team
- 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
- 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
- Thorough knowledge of applicable regulations, drug development,
and clinical project management procedures.
- Strong presentation, documentation, and interpersonal
- 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.
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company
in the world. That means we bring together the best clinical and
commercial minds to create a better, smarter, faster way to get
medicines into the hands of patients who need it most. Learn more
about Syneos Health.
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.
This position excludes Colorado applicants.
Keywords: INC Research Inc, Warwick , Assoc Dir, SSU Regulatory (Program Lead), Other , Carolina, Rhode Island
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