Senior Regulatory Operations Consultant in Boston

Job Description

Join American cloud-computing and Software company Veeva Systems, currently hiring Senior Regulatory Operations Consultant in Boston MA, Apply Veeva careers in Boston MA.

 

Position : Senior Regulatory Operations Consultant

Location : Boston, MA

 

Job Details

Veeva [NYSE: VEEV] is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, our customers range from the world’s largest pharmaceutical companies to emerging biotechs. Veeva’s software helps our customers bring medicines and therapies to patients faster.
We are the first public company to become a Public Benefit Corporation. As a PBC, we are committed to making the industries we serve more productive, and we are committed to creating high-quality employment opportunities.
Veeva is a Work Anywhere company which means that you can choose to work in the environment that works best for you – on any given day. Whether you choose to work remotely from home or work in an office – it’s up to you.
The Role
Do you want to be part of something new and up and coming?   Do you like digging in deep and solving problems?  Do you have a solid understanding of eCTDs and the nuances of successfully getting a submission to the Health Authorities?  Come help us shape a new paradigm for submissions publishing.  Veeva’s Vault RIM suite is the industry’s only unified software solution that provides fully integrated regulatory information management (RIM) capabilities including data and document management, submission publishing, and archival on a single cloud-based platform.   Veeva Systems is looking for experts in Regulatory Operations, specifically, eCTD publishing, who are dedicated and passionate about helping our customers hit their submission deadlines.   As a key member of the Professional Services team, the Publishing Consultant will be responsible for understanding our customers’ global regulatory eCTD publishing needs and assisting their use of Vault Submissions Publishing.   Opportunities are available within North America for this role; this is a remote position.  There is no work location requirement.  Qualified candidates are encouraged to apply. What You’ll Do Work directly with life sciences companies ranging from the world’s largest pharmaceutical companies to emerging biotechs Support Customers Vault Submissions Publishing activities immediately following technical and business go-lives Utilize best practices to support Vault Submissions Publishing deployment projects and ensure that customers realize the benefits of VSP Work collaboratively with the product team to pass on customer feedback regarding use cases and requests for product improvement Gain an in-depth understanding of Publishing use cases (eCTD, non-eCTD, Paper, Device) and how the Vault Submissions Publishing application aligns with those use cases Ensure continued customer success post-implementation go live Requirements Minimum of 4 years (8 for Senior) of pharmaceutical industry, regulatory publishing/submissions management experience Fluent understanding of regulatory submission processes and requirements including eCTD publishing principles and lifecycle management Working knowledge of health authority regulations and industry standards pertaining to regulatory operations Experience working with US and/or EU Regulatory Agencies supporting Regulatory Dossier review and approval processes Technologically savvy with the ability to quickly learn software applications and troubleshoot as needed Excellent skills in oral and written communications, integrity, and adaptability Ability to work independently in a fast-paced environment Nice to Have Direct experience with systems such as Veeva Vault or other submission publishing systems Consulting experience, working with a major system integrator or software vendor Regulatory Affairs, Regulatory Operations or Pharmacovigilance background Knowledge of Pharmaceutical, Biotechnology, and/or Medical Device and Diagnostics regulatory processes, data, and content Life Science, computer science, or related degree SaaS/Cloud experience #LI-Remote
#BI-Remote Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at talent_accommodations@veeva.com.

 

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