Jobs at IQVIA

Job Overview

• Acts as a Lead Medical Writer on projects. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Negotiates timelines and discusses/resolves customer comments, with senior support as needed. 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

• 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 presentation to an existing customer (e.g. on processes at a Kick-off meeting).
• Complete project finance activities, including monitoring and forecasting budgeted hours.
• Awareness of budgets and project finance principles, moving towards review and understanding of budgets relating to assigned projects, including out of scope activities.

Qualifications

• B Sc Degree in life sciences related discipline or related field.
• Typically requires 1-3 years of prior relevant experience and related competency levels.
• 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 effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output
• 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.
• Excellent written and verbal communication skills including grammatical/technical writing skills.
• Excellent attention to detail and accuracy.
• 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.
• Demonstrates good judgement in requesting input from senior staff.
• Ability to establish and maintain effective working relationships with coworkers, managers and customers.
• Ability to effectively manage multiple tasks and projects.
• Must be computer literate.

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Job Overview

• Performs quality control review of Medical Writing deliverables from internal and external authors to ensure accuracy, consistency, and compliance with format and style requirements

Essential Functions

• Conduct quality control (QC) review of a wide range of Medical Writing deliverables for both internal and external customers, including complex and substantial documents, with limited guidance and consistent high quality and efficiency;
• Document findings clearly, in accordance with defined procedures and checklists;
• Liaise promptly with document authors in case of questions or missing sources ;
• Provide service metrics and scores, as required;
• Develop quality tools such as checklists, quality guidelines, standards and scoring methodology to meet project specific needs;
• Identify quality issues and assist management team in implementing solutions;
• May provide training, guidance, and/or mentoring reviews to junior colleagues or explain QC processes to team members or customers;
• May propose revisions to standard operating procedures (SOPs) related to QC review or suggest process improvements for consideration;
• Contribute learnings to team meetings and help in improving overall quality of document delivery;
• May participate in project team meetings and liaise directly with the customer on QC issues, as appropriate and with senior support as needed;
• Take responsibility for on-time delivery of QC review comments;
• Manage daily assignments, planning and directing work, and take responsibility for managing workload for assigned projects and tasks, in collaboration with senior staff;
• Keep abreast of current data, trends, medical writing (MW)/regulatory knowledge, developments and advances in area of drug development/MW.

Qualifications

• B Sc Degree in Life science-related discipline or related field
• Typically, at least 4 years’ experience working with clinical trial documentation in a research environment, including significant experience of performing QC review of clinical trial-related documents  
• Careful attention to detail, accuracy, and consistency;
• Impeccable English language skills and ability to detect and correct grammatical, spelling, and language errors;
• Ability to understand scientific/medical documents and identify deficiencies, errors and inconsistencies;
• Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents;
• Proactivity and advanced organizational and time management skills and ability to prioritize workload effectively with commitment to deadlines;
• Ability to communicate clearly, concisely, and effectively in English, both in writing and verbally, and confidence in using a range of communication methods to achieve results;
• Good understanding of clinical drug development and the functions, steps, and processes involved;
• Advanced understanding of the nature and purpose of Medical Writing deliverables;
• Ability to provide thorough, appropriate, and sensitive feedback to less experienced colleagues;
• Confident use of Microsoft Office and Adobe Acrobat;
• Ability to quickly establish and maintain effective working relationships with co-workers, managers, and customers at a range of seniority levels.