Medical writer, Late phase research focused - (1807849) in Seoul, KR at IQVIA™

Date Posted: 6/29/2018

Job Snapshot

  • Employee Type:
  • Location:
    Seoul, KR
  • Job Type:
    Medical Writing
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

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.
  • Prepares or contributes to the production of any type of clinical document, for either internal customers or external clients, for investigational drugs, biologicals, or medical devices.
  • Participates in project teams and may provide service as an independent expert.
  • May serve as writing lead and project manager for medical writing projects.
  • Acts as Lead Medical Writer on most types of writing project, with limited guidance from senior staff. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with IQVIA SOPs and the customer's requirements. Participates in both internal and external project team meetings and liaises directly with the customer on medical and/or technical writing issues, including setting of project timelines, as appropriate and with senior support as needed. Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance.
  • Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Takes responsibility for planning and organizing workload for assigned projects and tasks. Offers proactive solutions and advice to customers as appropriate to experience.
  • Reviews and monitors budget for assigned projects, including out of scope activities, and ensures that revenue is recognised as appropriate. May provide independent review of budgets and costings for routine projects. Proposes costings for less routine projects, out of scope activities, and potential budget efficiencies, with guidance from manager.
  • May present on project-specific MW proposals at a full-service bid defense meeting (e.g. managing a series of projects to ensure consistency), with management input to slides as required.
  • May review documents or parts of documents prepared by other Medical Writers and provide appropriate feedback. Gives guidance to less experienced Medical Writers and assists in their training and development. May plan and deliver general training on Medical Writing to other IQVIA groups and externally, as appropriate
  • May present on standard medical and/or technical writing processes at full-service bid defence meetings by telephone or in person. May input into and deliver presentations on medical/technical writing to other IQVIA groups.
  • May act as Project Manager for a small stand-alone medical and/or technical writing project (e.g. protocol or CSR). May coordinate medical and/or technical writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking.
  • Keeps abreast of current data, trends, medical and/or technical writing/regulatory knowledge, developments and advances in area of drug development/medical and/or technical writing.
  • May propose revisions to SOPs or suggest process improvements for consideration. Complies with Company SOPs and participates in the implementation of new SOPs.
  • May represent region or site on a MW initiative or cross-functional initiative.

Job Requirements

Minimum Qualification

•         Bachelor’s degree in a life science-related discipline, communications, technical writing, or related field

•         2-5 years' broad-ranging experience as a medical writer within a pharmaceutical environment, including lead writer roles in preparing clinical study protocols and/or method validation and study data reports; or equivalent combination of education, training and experience.

•         Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.

•         In-depth knowledge of the structural and content requirements of clinical or method validation and study reports, protocols, and similar documents for internal and external clients.

•         Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of their results.

•         Knowledge of regulations relevant to medical/technical writing and other relevant regulatory agencies

Additional Qualification

•         Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.

•         Demonstrated ability and experience to work independently on most writing projects, with limited senior guidance.

•         Understanding of the time needed to perform routine medical and/or technical writing tasks in order to agree on appropriate timelines and provide accurate resource estimates and costings. Knowledge and understanding of necessary budget assumptions.

•         Ability to give a presentation to a project team and/or customer on project-specific topics, with an air of competence and authority.

•         Ability to identify deficiencies, errors, and inconsistencies in a protocol or report.

•         Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output as related to acceptance criteria according to SOPs.

•         Confident and effective communication and negotiation skills with customers and project managers.

•         Experienced and effective in providing feedback and guidance to more junior staff.

•         Developing skills in chairing small meetings.

•         Ability to work on several projects at once while balancing multiple and overlapping timelines.

•         Ability to assess and prioritize workload.

•         Demonstrated abilities in collaboration with others and independent thought.

•         Careful attention to detail and accuracy.

•         Must be computer literate.

•         Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Preferred Qualification

•         Work experience in CROs or pharmaceutical companies

•         Work experience in late phase study including PMS or observational study

We 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: 1807849