Manager (Backend Team Lead) (R1106954) in Seoul,SK at IQVIA™

Date Posted: 11/29/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Seoul,SK
  • Experience:
    Not Specified
  • Date Posted:
    11/29/2019
  • Job ID:
    R1106954

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

Role Purpose:  

  • Design, writes, reviews, and coordinates technical documentation regarding clinical trials in line with client specifications and industry practices. 
  • Line Manage backend staff including medical writers, Biostats and preferably data management staff.


RESPONSIBILITIES

  • People manager role for Medical writer, Biostatistician and Data Management team.  
  • Review to the preparation of clinical documents, for either internal customers or external clients, for investigational drugs, biologicals, or medical devices. 
  • Collaborates with internal experts and specialists; conducts thorough research; maintains expertise on developments in a particular field of focus. 
  • Resource assignment, line management of backend teams (Medical writers, biostats and data management staff) 
  • Cross-functional collaborates with clinical operation team, business development team for issue management & external meetings 
  • Manage a team of Backend functions (MW, BIOS and DM). 
  • Provide direction and guidance in carrying out project assignments, interfacing with clients and other internal departments. 
  • Communicate on project progress, staffing, and resource allocation with the Director, as needed. 
  • Coordinate the development of new SOPs and develop training modules jointly with other department managers. 
  • Participate as a chief medical writer on major projects, including developing/reviewing protocols. 
  • Understand and interpret study objectives and clinical trial data and the regulatory and scientific requirements of the documents we prepare 
  • Demonstrate a solid understanding of study design
  • Confidently work with others to develop study protocols from brief outlines, and take responsibility for a variety of clinical documents for a wide range of both international and local sponsors, across all therapeutic areas  
  • Coordinate and lead local and global writing teams for programs of studies 
  • Apply knowledge and experience in the training and guidance of more junior writers 
  • Interact directly with international project team members and sponsors, proactively manage his/her own deliverables, and identify and respond appropriately with solutions to any potential issues and problems 
  • Multi-task, balancing project lead roles on protocol writing with review responsibilities for others, and helping out colleagues in the team on a planned or ad hoc basis 
  • Work with minimal direction, identify project needs, and create project timelines

 
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

  • A minimum of a Bachelor’s degree in a life science-related discipline 
  • Preferred Protocol development and design in medical writing  
  • Broad-ranging experience as a medical writer within a pharmaceutical research environment including lead writer roles in preparing clinical study protocols and/or reports for Phase I to IV, PMS and Medical device trials. 
  • Work both independently and as part of a team 
  • Communicate confidently, assertively, and diplomatically, both verbally and in writing 
  • Show initiative, apply experience to new tasks, and convey enthusiasm and interest demonstrate a solid scientific academic background, together with existing regulatory medical writing experience. 
  •  At least more than 10 years of prior relevant experience (experience in protocol design, development is mandated)  
  • Good English communication and written skill are required.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.



Job ID: R1106954