Sr Reg Intelligence Consultant (Project Management)

Description

Senior Regulatory Intelligence Associate

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

• Gather new regulatory information through routine surveillance of agreed regulatory sources.
• Reviews surveillance alerts and queries and determine actions to be taken.
• Conduct regular annual country review of regulatory source documents for the clinical regulatory intelligence.
• Support ad-hoc research requests from the business and gather regulatory information for potentially new topics.
• Interacts with internal experts to collect country and region-specific regulatory intelligence.
• Conducts searches within commercial Regulatory Intelligence databases to find regulations and guidelines relevant for clinical regulatory intelligence.
• Identifies and responds appropriately to issues and problems, providing innovative and effective solutions.
• Recommends and support implementations of enhancements of Syneos Health Regulatory Intelligence processes to maintain the Regulatory Intelligence System.
• Manage translation requests of regulations and guidelines.
• General team organization tasks (internal meetings, follow-up activities etc.)
• Undertake department activities including departmental metrics, MS Teams and SharePoint updates.
• Maintains overall awareness in the field of regulatory intelligence as well as applicable regulatory requirements by reading related literature, attending training classes, attending professional meetings, etc. 
• Other tasks as needed.

Qualifications

What we’re looking for

• BA / BS in life sciences, regulatory intelligence, regulatory affairs, regulatory operations or related field required or regional equivalent or equivalent combination of education and experience.
• Experience in a work-related area preferred. 
• Ability to analyze information across multiple sources and manage large amounts of details.
• Strong research skills needed to support routine surveillance activities to detect, monitor, and synthesize complex regulatory information.
• Ability to interact with stakeholders from multiple departments at different seniority levels.
• Ability to work independently and to understand and conduct detailed instructions.
• Strong written and oral communication skills 
• Excellent problem solving and decision-making skills.
• Fluent in speaking, writing, and reading English.

Get to know Syneos HealthOver 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.

“Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability.”

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.