Job Description

Overview

You\xe2\x80\x99re driven, resourceful, and above all else - remarkably smart.

You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn\xe2\x80\x99t cut it \xe2\x80\x93 you\xe2\x80\x99ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you\xe2\x80\x99re known for your good nature. You\xe2\x80\x99ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

Responsibilities

This opportunity is with Syneos Health Consulting, an industry-leading consulting firm specializing in the biopharmaceutical industry providing services across a comprehensive range of key Practice Areas including commercial strategy and planning, medical affairs, risk and program management and pricing and market access. You\xe2\x80\x99ll join a team with industry focus, depth of functional expertise, and strong scientific and market knowledge that is uniquely positioned to tackle highly complex business and market challenges to develop achievable strategies for our clients. High-level details in one sentence about the role.

More specifically:
This opportunity is with Syneos Health Consulting. Your primary focus will be to conduct External GCP Audits. You will work with some of the industries sharpest minds, and will enjoy flexibility to conduct your professional Pharmaceutical and Biotech Clinical Audits as the lead and primary auditor. To be successful in this role, you will need to have extensive experience as the lead or primary auditor conducting external clinical trial audits, deep understanding of CRO auditing and excellent communication skills.

You will be joining an industry-leading consulting firm, Syneos Health, specializing in the biopharmaceutical industry providing services across a comprehensive range of key Practice Areas including commercial strategy and planning, medical affairs, risk and program management and pricing and market access. You\xe2\x80\x99ll join a team with industry focus, depth of functional expertise, and strong scientific and market knowledge that is uniquely positioned to tackle highly complex business and market challenges to develop successful commercial strategies for our clients.

Primary Responsibilities:
In this role, you will schedule, conduct and document assigned audits of projects in accordance with approved procedures, schedules and formats. Specific audit areas will include, but are not limited to: investigator sites, trial master and project management files, data management activities and files, safety reporting, final study reports, and vendors. More specifically:

Lead for-cause audits to address suspected critical audit findings, fraud, or misconduct related to investigator sites, vendors, etc. These complex and highly sensitive audits may involve issues related regulatory violations, controlled substances, and other highly sensitive matters.
Conduct audit debriefs with project teams and/or sponsor
Writes and issue audit reports in accordance with standard company formats and timelines, ensuring clear communication of audit findings to the relevant project team members.
Maintain accurate and timely documentation of QA auditing activities.
Serve as a trainer and mentor to newly hired QA Auditors.
Serve as Global Lead Auditor on projects as assigned.
Maintain subject matter expertise through training (internal and external), review and/or preparation and presentation of papers, review of guidelines, and regulations, etc.
Participate in Trusted Process meetings such as Kick-off, Quick Start Camp, and Quality Finish Camp.

Job Requirements

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn\xe2\x80\x99t align perfectly, we encourage you to apply anyway. At times, we take into consideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:

University/college degree BA/BS related to life sciences
Pharmacovigilance Canadian audit experience and GCP experience. The candidate must have performed pharmacovigilance investigator site audits.
Expertise with ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs
Knowledge of the drug development process
4 years CRO/Pharmaceutical experience
4 years in a GXP quality role, including at least 2 years in a GCP quality audit role required

Competencies:
Excellent written and oral presentation skills
Superior MS office skills (Excel, PowerPoint, Word)
Excellent organization and planning skills and attention to detail
Proven interpersonal skills
Demonstrated ability to handle multiple competing priorities
Ability to function in a team based environment as a member of a Global Quality Team

#LI-KS2

At Syneos Health, we believe in providing an environment and culture in which our people can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality of life balance.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Here, you\xe2\x80\x99re a part of the big picture. We work hand in hand to guide pre-market development through post-market commercial strategy. Knowledge sharing across advisory groups unlocks the innovation and unique strategies our end-to-end commercialization projects require. Our collaborative mindset means every project is a chance to solve a new challenge, learn from your teammates, become better-rounded, and evolve your career.

WORK HERE MATTERS EVERYWHERE | How will you accelerate biopharmaceutical commercialization?