Technical Writer - (R1022681) in Mumbai, IN at IQVIA™

Date Posted: 6/6/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Mumbai, IN
  • Job Type:
    Communications
  • Experience:
    Not Specified
  • Date Posted:
    6/6/2018
  • Job ID:
    R1022681

Job Description

Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

This job description reflects major responsibilities globally and is not intended to reflect all possible duties and responsibilities for each employee in this job title. Management has the right to assign all or a portion of the duties and responsibilities of this job based upon business needs.

 

  • To handle increasing demand of clients on analytical end of study reports for biomarker testing.
  • Technical Writing Responsibilities: Writing of custom bioanalytical reports, study reports and Standard Operating Procedures.
  • General Responsibilities: Data review and QC of completed studies. Interacting with different departments (including QA, Project Management, Scientific Affairs and Data Management) in order to accumulate study information and to determine the cause of and solution for any issues. 
  • Quality Assurance Responsibilities: Responding to QA and client audits. Coordinating execution of corrective and preventative actions. Implementation of appropriate QC, QA and regulatory (CAP/CLIA/GCP) guidelines in the laboratory.
  • Manage all aspects of regional clinical laboratory quality control including the implementation of global quality control criteria for individual assays, review of all regional laboratory QC activities, biannual assays checks and proficiency testing programs as required by regulatory agencies.
  • Manage all aspects of local clinical laboratory new assay validation/performance qualification, methods transfers to/from other regional clinical laboratories or from the Assay Development Laboratory.
  • Manages all aspects of local clinical laboratory analytical instrument and equipment program including the design, testing, implementation and review of instrument validation documentation as well as overseeing calibration, maintenance and change control.
  • Manage all aspects of local clinical laboratory technical support program including technical review of laboratory requirements for new studies during the study set up phase, provision of local laboratory test updates to maintain the Scientific Database, provision of test code assignment, worksheets, specimen requirements, shipping conditions and blood volume charts.
  • Manage all aspects of the local provision of reference laboratory testing information to other departments including the establishment of standards and service level agreements between laboratories globally and locally. Monitoring service level agreements with regional, local and reference, laboratories to ensure compliance.
  • Represent and leads Technical Services team in audits/inspections from regulatory agencies and pharmaceutical sponsors within the local lab.
  • Interact with external vendors and sponsors regarding local clinical laboratory requirements and issues.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

 

  • Knowledge of clinical laboratory regulations, GxP and /or ICH guidelines
  • Knowledge of laboratory equipment, clinical laboratory assays, quality control and validation procedures
  • Proficiency in PC applications such as word processing, spreadsheets, database management
  • Excellent attention to detail, organizational skills, verbal and written communication skills
  • Ability to work independently as well as in a team environment
Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Job Requirements

N/AWe know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.



Job ID: R1022681