Sr. Coordinator/Coordinator-BEC Project Management
Apotex Inc
Bangalore, KA, IN
2d ago

Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world.

We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion.

  • Our fully integrated operation is comprised of four lines of business : Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API);
  • and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year.

    We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

    Job Summary

    Works closely with the Team Leader to update on all projects related activities in PHRMSCHED and preparation of NOC & TL applications to DCGI Responsible for communicating project related updates to relevant project teams.

    Works with internal departments of ARPL-BEC to ensure, compilation and verification of Bio reports in Docubridge before submitting to the internal regulatory affairs group and issues of controlled forms to Clinical operations department.

    Executes other duties as may be assigned by the management and as training and experience allow.

    Job Responsibilities

  • Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Center’s Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
  • Supervises administrative assistance with report compilation and archival of study data post-study.
  • Supervises review of report compilation and archival of study data post-study.
  • Works as a member of a team to achieve all outcomes.
  • Perform all work in support of our corporate values of pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
  • Performs all work in accordance with all established regulatory and compliance and safety requirements and all other duties as assigned
  • Coordinate with Project Coordinator, Team Leader and relevant team members to discuss project updates and ensure project timelines are not compromised.
  • Supervises the coordination with relevant departments / CROs on study reports for compilation and populate into relevant software before submitting to the internal regulatory affairs group for both internal and CRO projects.
  • Provides administrative assistance with report compilation and responsible to coordinate with relevant departments / CROs for all the supporting documents required for the bio report submission (FDA Tables, CS-
  • BE, Investigator documents etc.).

  • Responsible for issue of controlled forms to operations controlled by BEC-Projects.
  • Executes other duties as may be assigned by the management and as training and experience allow.
  • Participates in the creation, development and revision of ARPL BEC SOP’s.
  • Preparation NOC and TL applications to DCGI for permission to conduct bioequivalence / bioavailability studies
  • Responsible for updating the projects status in the relevant database
  • Science Graduate

    Previous experience in data management

    Proficient in the use of Microsoft Office software

    At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

    Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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