Project Specialist, Aggregate Safety Reporting

Celgene Corporation Summit , NJ 07901

Posted 12 months ago

Job Description: Req #: 1900920

Location: Summit, New Jersey, United States

Job Category: Medical

Work Location: 556 Morris Avenue 07901

Organization: Drug Safety

Employee Status: Full-time

Job Type: Regular

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

  • Creating and maintaining the ASR project schedules

  • Ensuring all contributors are maintaining compliance with time lines

  • Tracking ASRs and their due dates

  • Plan, schedule, coordinate and lead kick-off, strategy and comment resolution meetings

  • Plan, schedule and coordinate resources (people and time) needed for ASR creation

  • Identify all personnel involved in ASR preparation prior to kick-off meeting

  • Lead ongoing ASR production meetings

  • Solicit information for ASRs from identified contributors via email

  • Create workflows (review and approval) for each of the ASRs in the document management system

  • Liaising with PV/EPI group supporting approved products and activities

  • Liaising with TSS group supporting development products and activities

  • Liaising with Regulatory Affairs to coordinate contributions for and synchronization of periodic reports

  • Liaising with other contributing groups as appropriate

  • Schedule additional meetings as needed to resolve issues

  • Collaborate on the drafting of key SOPs & WPs related to ASR processes

  • Perform other activities as needs arise in the context of ASRs

  • Representing ASR and collaborating with business partners to promote streamlined processes

Skills/Knowledge Required:

  • Education: BA or BS in Business, Engineering, Computer Science, Health Science or similar

  • Certification: PMP certification is a plus

  • Experience: One to two years relevant experience in pharma/biotech, preferably in PV; One or more years relevant experience in project planning desirable

  • Excellent skills and proficiency with Microsoft Office products: Word, Outlook, Project, Excel, PowerPoint required; Visio and Livelink (or similar document management platform) desirable

  • Experience with safety databases (ARISg or similar) and reports is desirable

  • Experience with document management systems and/or electronic shared work spaces, e.g., SharePoint

  • Ability to identify existing or potential deficiencies in procedures, and recommend solutions for process improvement

  • Strong communication skills (both oral and written) and the ability to interact with various levels, both within GDSRM as well as other parts of the organization

  • Knowledge of US, EU and ROW PV regulations

  • Demonstrated ability to work independently with effective presentation and interpersonal skills to ensure a team-oriented approach

  • Ability to demonstrate a familiarity with general principles of PV

  • Ability to work as part of a team, multi-task and meet internal and regulatory deadlines

About Us


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.

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Project Specialist, Aggregate Safety Reporting

Celgene Corporation