Celgene Sr. Project Specialist, Aggregate Safety Reporting 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.

Summary:

Reporting to the Senior Director – Global Drug Safety & Risk Management, Aggregate Safety Reporting, the Sr. Project Specialist facilitates Aggregate Safety Report (ASR) production activities across GDSRM including PSURs, DSURs, US PSRs, Addendum reports, Renewal reports, and other reports as required.

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

#LI-POST

Qualifications

Skills/Knowledge Required:

  • Education : BA, BS, MA or MS in Business, Computer Science, Health Science or related discipline

  • Certification : PMP certification is desirable

  • Experience : Five (5) years relevant experience in pharma/biotech, preferably in PV; Three (3) 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)

  • 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

  • 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 principles of PV

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

  • Familiarity with safety database outputs, preferably ARISg and reporting tools, eg Business Objects

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.

Sr. Project Specialist, Aggregate Safety Reporting

Location: Summit, NJ, US

Job ID: 17001864