Description

Clinical Regulatory Affairs Manager

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

Collaborates with major functional areas including, but not limited to: Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing. Identifies and evaluates fundamental issues pertaining to project regulatory pathway, successful patient enrollment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented.   Ensures all project deliverables meet the internal and customers’ expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk identification, mitigation and management. Develops and maintains relationships with customers in alignment with their assigned projects.  Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed.   Strong Knowledge of the drug development process, regulatory sciences and Clinical Trial Applications. Focuses on managing or leading regulatory processes, compliance, and documentation for clinical trials. Develops plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes.  Complies all controlled document requirements and other requirements to ensure quality deliverables. Develops and manages integrated timelines and reports weekly progress including plans to address potential timing risks/gaps. Uses professionally recognized tools for planning and management of scope, timeline, and resources and ensures effective budget management.  Thorough understanding of systems used to support submissions and planning activities. Responsible for or assists in initial or amendment updated development of master Subject Information Sheet (SIS) /Informed Consent Form (ICF) in collaboration with the PM and Medical Department. Oversees collation, quality review, and submission of country-specific applications. 

Qualifications

What we’re looking for

Bachelor’s Degree, Higher Degree Preferred. Minimum 6 years CRO industry experience and/or a minimum 5 years’ experience working in a Regulatory, or clinical trial environment or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job. Understanding of EU- CTR Excellent understanding of clinical trial process across Phases II-IV and ICH GCP  Good understanding clinical protocols and associated study specifications.  Excellent understanding of clinical trial start-up processes.  Project management experience in a fast-paced environment.   Good vendor management skills  Strong organizational skills with proven ability to handle multiple projects.  Excellent communication, presentation and interpersonal skills.  Quality-driven in all managed activities.  Strong negotiating skills.  Strong problem-solving skills.   Demonstrate an ability to provide quality feedback and guidance to peers.

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.