Dear Recruiter, Here is our Direct client requirement which can be filled immediately. Kindly respond to this requirement with your *consultant resume, contact and current location* info to *speed up the interview process.*
Role # 1 – Senior Project Manager (clinical development) Role # 2 – Project Manager (clinical development) Duration: Multi-year project Location is Upper Gwyneth, PA or Rahway, NJ (Flexible). *High-level Project Work:* · Parexel configuration update of the ORION (current legacy application) · Publishing Environment Update - Insight 5.1 to Insight 6.0 · Veeva Gap analysis *Domain Experience* · Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs. · Broad knowledge of drug development process and client needs · Prior experience working on regulatory submissions · Familiar with 21 CFR part 11, GXP and other Life Sciences regulations *Technical Experience* · Experience with LIQUENT Insight publisher, Veeva platform strongly preferred; however, consideration will be giving to candidates with experience with other electronic publishing systems · Experience with Waterfall and Agile development · Thorough understanding of Software Development Life Cycle (SDLC) and all related documentation *PM Skillsets* · PMP Certified · Experience managing cross functional teams with timeline management and budgetary responsibility · Provide Coordination, planning and oversight for business (process changes, SOP updates, Training, change management, communication, etc.) and IT (manage multiple suppliers, internal Merck service groups, development and testing activities, etc.) activities Regards, Vasavi G Team Lead Desk: 770 410 7770 ext 371 Email: [email protected] <[email protected]%20/%[email protected]> LinkedIn: https://www.linkedin.com/in/vaasavi -- You received this message because you are subscribed to the Google Groups "IT Auditor Resumes" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/itresumes. For more options, visit https://groups.google.com/d/optout.
