Principal Medical Writer - FSP

IQVIA; Lisboa; Presencial; EUR 76 000 - 111 000; Tempo integral

Resumo da oferta

IQVIA is seeking a Lead Medical Writer to act as the primary writer on complex documents, ensuring alignment with SOPs and customer requirements. You will lead review cycles, negotiate timelines, and ensure high-quality deliverables across global teams.

The role involves mentoring junior staff, presenting at bid defenses, and may include project management and budgeting duties to support senior leadership in a regulated environment.

Qualificações

• Lead writer with CSR and protocol experience.
• Strong knowledge of GxP and regulatory writing standards.
• Identify deficiencies and ensure accuracy in reports.
• Excellent written and oral communication skills.
• Ability to manage multiple tasks and projects.

Responsabilidades

• Lead the preparation of documents, confirm scope, templates, timelines, and coordinate reviews.
• Plan workload, track timelines, and implement customer requests.
• Lead meetings on challenging topics.
• May present Medical Writing processes at bid defense meetings.
• Mentor junior staff and deliver global training.
• Possibly act as Project Manager including Finance/Invoicing.
• Complete project finance activities and forecast hours.
• Propose and approve budgets for routine projects.
• May take on a small customer lead role.
• Represent region or site on initiatives.
• Facilitate ideas and participate in capabilities audits.

Conhecimentos

Lead writer

Regulatory writing

Project management

Client interaction

Mentoring

Formação académica

Bachelor's Degree in life sciences

Master's Degree

Ph.D. in life sciences

Descrição da oferta de emprego

Reading, Berkshire, United Kingdom

Lisbon, Portugal

Brussels, Brussels-Capital Region, Belgium

Belgrade, Serbia

Barcelona, Spain

London, United Kingdom

Madrid, Spain

Full time

R1571038

Job Overview

Acts as Lead Medical Writer on most types of writing projects. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Performs Senior Review of straightforward medical writing deliverables. Negotiates timelines and discusses/resolves customer comments.

Provides written and verbal feedback to junior staff, and to customers when appropriate.

Keeps abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (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.

• Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.

• Lead meetings on more challenging topics independently.

• May present on standard Medical Writing processes at full-service bid defense meetings.

• Assist in the training and development of junior staff, either formally as an assigned mentor or ad hoc for local colleagues or others. May develop and deliver training to the global team on a topic he/she has specific expertise in. May input into and deliver presentations on Medical Writing to other IQVIA groups.

• May act as Project Manager for a more complex but single Medical Writing project which includes Project Finance/Invoicing responsibilities.

• Complete project finance activities, including monitoring and forecasting budgeted hours.

• Propose, review and approve budgets and costings for routine projects, including estimation of hours needed for Medical Writing tasks.

• May take on a small customer lead role or assist an established partnership lead in their role.

• May represent region or site on a Medical Writing initiative or cross-functional initiative.

• Facilitates and brainstorms the identification of new ideas. May represent Medical Writing at a general capabilities audit.

Qualifications

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

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

• Ph.D. Ph.D. in life sciences related discipline or related field Pref

• Typically requires at least 5 years of highly relevant experience and related competency levels.

• In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in a protocol or report.

• 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.

• Significant experience as a lead writer in preparing CSRs and protocols, with consistently positive feedback from customers and colleagues.

• 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 oral communication skills including grammatical/technical writing skills.

• Excellent attention to detail and accuracy.

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

• Able to deliver difficult messages in constructive manner.

• Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.

• 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.

• Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers.

• Must be computer literate.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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