Principal Medical Writer - FSP (M/W/D)

IQVIA Inc; Madrid; On-site; EUR 90,000 - 130,000; Full time

Job summary

IQVIA is seeking a Principal Medical Writer to lead the development of regulatory documents for submissions to regulatory authorities worldwide. You will provide strategic direction to cross-functional project teams to ensure data-driven clinical messages are accurate and well-presented.

The role requires a Bachelor’s degree (advanced degree preferred) and at least 5 years of medical writing experience in the biopharmaceutical/CRO space.

Qualifications

• Bachelor's degree with relevant scientific/clinical/regulatory focus.
• Advanced degree preferred in a relevant field.
• 5+ years medical writing experience in biopharmaceutical/CRO.
• Proficient in organizing and presenting clinical data with minimal oversight.
• Strong verbal, written and interpersonal communication, time management and project management skills.

Responsibilities

• Develop regulatory documents for global regulatory submissions (IBs, CSRs, submission dossiers).
• Provide strategic direction to cross-functional project teams with minimal oversight.
• Oversee medical writing activities across multiple compounds and serve as lead writer for summaries.
• Review and ensure accuracy and regulatory compliance of documents and data presentation.
• Lead process improvements and define writing SOPs and best practices.
• Manage internal and contract medical writing resources to meet timelines.

Skills

Regulatory writing

Project management

Cross-functional leadership

ICH guidelines

Education

Bachelor's degree

Advanced degree

Job description

Frankfurt, Hesse, Germany

Belgrade, Serbia

Paris, France

Amsterdam, Netherlands

Dublin, Ireland

Barcelona, Spain

London, United Kingdom

Madrid, Spain

Bucuresti, Romania

Lisbon, Portugal

Brussels, Brussels-Capital Region, Belgium

Copenhagen, Denmark

Stockholm, Sweden

Full time

R1577397

Principal Medical Writer is responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents. Has a broad understanding of clinical research processes and global regulatory document standards.

Essential Function s

Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and client's authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.

Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.

Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.

Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.

Participate in cross-functional process improvement initiatives.

Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.

Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.

Qualifications

Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred.

At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development.

Proficiency in organizing and communicating clinical information required with minimal oversight.

Strong organizational, time management, and project management skills are required.

Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.

Proficient understanding and knowledge of global regulatory requirements needed and knowledge of therapeutic areas in all phases of clinical development desired.

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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