Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
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 deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
Regulatory Submissions Coordinator Manager
Required Knowledge/Skills
- Create and Maintain Content Plans within Veeva Vault RIM
- Translating Smartsheet timelines into Microsoft Project and Veeva Vault RIM
- Assist with planning, managing, and tracking of regulatory submissions
- Support Global Submission Managers with project management activities, tasks and tracking
- Assist with coordination and communication of regulatory submissions to Publishing
- Ability to work with firm deadlines and adapt quickly to changing requirements and priorities.
- Excellent organization, written/verbal communication to explain difficult information, and attention to detail.
- Submission Technology: Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems. Keywords: Insight Publisher, Lorenz Publisher, Veeva Vault RIM, Content Planning, eCTD Viewers, DXC (ISI) Toolbox
- Project Management Technology: Experience and proficiency with project management tools and software. Keywords: Smartsheet, Microsoft Project, Excel, Office timeline Pro
Required Education Level & Experience
- B.S. (or equivalent experience) and 5+ years of Regulatory Affairs Work Experience, with a focus on publishing and/or submissions
- M.S. (or equivalent experience) and 3+ years of Regulatory Affairs Work Experience, with a focus on publishing and/or submissions
- In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards. Keywords: eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS
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.
http://www.syneoshealth.com
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.
