Principal Medical Writer - FSP

IQVIA; Barcelona; Presencial; EUR 70.000 - 110.000; Jornada completa

Descripción de la vacante

IQVIA in Barcelona is seeking an experienced Lead Medical Writer to manage CSR and protocol documents, coordinating with customers and leading review cycles in line with IQVIA SOPs and timelines.

The role includes mentoring junior staff, presenting process overviews, and potentially handling project finance for selected writings, with a focus on accuracy and regulatory understanding.

Formación

• Bachelor's degree in life sciences related discipline.
• Master's degree in life sciences related discipline.
• Ph.D. in life sciences related discipline.
• Typically requires at least 5 years of highly relevant experience.
• Knowledge of clinical study reports, protocols, and related documents.
• Understanding of statistical methods used in clinical trials.
• Ability to review statistical analysis plans for deficiencies.
• Ability to summarize data from multiple sources clearly.
• Lead writer experience for CSRs and protocols with positive feedback.
• Knowledge of drug development and medical writing regulations.
• Excellent written and oral communication skills.
• Excellent attention to detail and accuracy.
• Strong communication and negotiation with customers and project managers.
• Ability to deliver constructive messages.
• Demonstrates initiative and sound judgement.
• Collaborative and independent thinking.
• Confidence in routine medical writing scenarios.
• Ability to seek input from senior staff.
• Ability to manage multiple tasks and projects.

Responsabilidades

• Lead preparation of assigned documents, confirm scope, templates, and timelines.
• Plan and organize workload for projects; track timelines and client requests.
• Lead meetings on challenging topics independently.
• Present at standard Medical Writing process meetings when needed.
• Mentor junior staff and input into training for global teams.
• May act as Project Manager on complex Medical Writing projects including budgeting.
• Complete project finance activities and forecast hours.
• Propose budgets and costings for routine projects.
• Possibly represent region or site on initiatives.
• Brainstorm new ideas and participate in capabilities audits.

Conocimientos

Lead writer

Senior review

Client communication

Project management

Budget/finance awareness

Regulatory knowledge

Data interpretation

Attention to detail

Educación

Bachelor's degree in life sciences

Master's degree in life sciences

Ph.D. in life sciences

Descripción del empleo

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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