Job Overview

• Provides high quality, on-time input to client projects in the life sciences field. Assignments typically require analysis and problem solving within an established framework.

• Serves as a Lead Medical Writer for late phase studies of Real-World Solutions team. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines.

• Keeps abreast of current medical and/or technical writing/regulatory knowledge, including GCP, along with developments and advances in drug development/medical and/or technical writing.

Essential Functions

• Under supervision, assists with the review and analysis of client requirements or problems and assists in the development of client solutions.

• Assists in the development of detailed documentation and specifications.

• Under supervision, performs quantitative or qualitative analyzes to assist in the identification of client issues and the development of client specific solutions.

• Assists in the design and structure of presentations that are appropriate to the characteristics or needs of the audience.

• Proactively develops a basic knowledge of consulting methodologies and the life sciences market through the delivery of consulting engagements and participation in formal and informal learning opportunities.

• Engagement based responsibilities are assigned and closely managed by Consultants, Senior Consultants, Engagement Managers or Principals in the APAC region

• Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.

• Manage day-to-day workload: identify project needs, track timelines and implement customer requests, keeping manager/senior staff abreast of progress on tasks and any potential problems with project work.

• Attend project team meetings with or without other writers. Participate in/lead comments resolution or similar meetings with external customers.

• May give simple presentation to an existing customer (e.g. on processes at a Kick-off meeting).

• Complete project finance activities, including monitoring and forecasting budgeted hours as well as understanding of budgets relating to assigned projects, including out of scope activities.

Qualifications

• Bachelor's Degree in life sciences related discipline or related field

• Typically requires 1-3 years of prior relevant experience and related competency levels.

• Requires knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education.

• Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.

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

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

• In depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.

Skills and Abilities

• Works willingly and effectively with others in and across the organization to accomplish team goals.

• Excellent written and oral communication skills including grammatical/technical writing skills.

• Knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision making, growth and decline.

• Knowledge of consulting methods, tools and techniques, related to one’s functional area.

• Excellent attention to detail and accuracy.

• Knowledge of current events and developments within an industry and major competitors.

• Knowledge and understanding of the marketplace. Knowledge of professional/trade associations, key people and companies.

• Effective time management skills.

• Communicates clearly, effectively and confidently with others.

• Demonstrated abilities in collaboration with others and independent thought.

• Demonstrates confidence and maturity in most routine medical writing situations.

• Ability to effectively manage multiple tasks and projects.

• Confidence in building relationship with customer and discussing medical writing issues with customers in person, via e-mail or on the telephone.