Regulatory Consultant (Veeva RIM)

Syneos Health; California (MO); Hybrid; CAD 85,000 - 120,000; Full time

Job summary

Syneos Health in Canada is seeking a Regulatory Affairs Publication Specialist to manage content planning and submissions within Veeva Vault RIM.

You will translate Smartsheet timelines into MS Project, assist with planning, tracking, and coordination of regulatory submissions, and support global teams in publishing activities while meeting strict deadlines.

Qualifications

• Regulatory submissions and publishing experience.
• Understanding of FDA/EMA/ICH guidelines and eCTD standards.
• Experience with regulatory information management systems and submission tools.

Responsibilities

• 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 Vertex Global Submission Managers with project management activities, tasks and tracking.
• Assist with coordination and communication of regulatory submissions to Vertex 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.

Skills

Regulatory affairs

Project management

Attention to detail

Education

B.S. in Regulatory Affairs or Life Sciences

M.S. in Regulatory Affairs or Life Sciences

Tools

Veeva Vault RIM

eCTD

Smartsheet

Microsoft Project

Excel

Office Timeline Pro

Job description

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

• 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 Vertex Global Submission Managers with project management activities, tasks and tracking
• Assist with coordination and communication of regulatory submissions to Vertex 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.

Discover what our Syneos Health colleagues already know: work here matters everywhere.

Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you’ll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.