Celgene Sr. Systems Specialist, Global Regulatory Operations in Summit, New Jersey

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Celgene's Regulatory Information Systems group within Global Regulatory Operations is looking for a candidate, who will be responsible for day to day operations of regulatory systems, creation of user manuals, training related documentation and provide user training. This person must be able to understand the business needs and have experience working on regulatory information systems. This person will collaborate with business users to understand business needs, troubleshoot any system issues and able to recommend process improvements based on day to day operations and lessons learned.

PREREQUISITES

BA/BS in a relevant discipline; 3-5 years in a Life Sciences industry experience

Responsibilities will include, but are not limited to the following:

  • Support day to day management of the Global Regulatory Information systems including but not limited to:

  • eSub (Document Management System)

  • eCTDXPress (eCTD Submissions Publishing System)

  • GLTS (Labelling Tracking System)

  • eQRMS PR module (Submissions Tracking System)

  • Pre-Approval Access (SharePoint Workflows System)

  • Provides regulatory systems training and support to new users and current users.

  • Collaborate with users to develop an understanding of business needs and take those business needs to next level

  • Work collaboratively with multi-site team members and cross-functional departments

  • Maintains/updates user & training materials.

  • Ensures compliance with SOPs and WPs. Supports development of new SOPs, WPs, or best practices documents for regulatory systems.

  • Support technology roadmap for Global Regulatory Affairs

Skills/Knowledge Required:

  • 3-5 years of pharmaceutical industry experience required. Regulatory systems experience will be preferred.

  • Good written and oral communication skills.

  • At least 2 years of working experience on document management systems, such as Veeva, SharePoint or OpenText Content Server

  • Good business documentation writing skills

  • At least 2 years of experience in creating training material and providing user training

  • Ability to work and contribute in a team environment.

  • Ability to perform tasks proactively with minimal supervision.

  • Experience with regulatory systems in a life sciences industry

  • Ability to effectively interface with business users and the technical team.

  • Strong attention to detail

#LI-POST

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.