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

IQVIA; Oeiras; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

IQVIA is seeking a Principal Medical Writer to lead the development of regulatory documents for global submissions. You will provide strategic direction to cross-functional teams and oversee multiple compounds, ensuring data is presented accurately and clearly according to regulatory standards.

The role requires a strong background in biopharmaceutical medical writing, experience with ICH guidelines, and the ability to manage timelines and resources with minimal supervision.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• At least 5 years of medical writing experience in biopharmaceutical/CRO industry or similar.
• Proficiency in organizing and communicating clinical information with minimal oversight.
• Strong organizational, time management, and project management skills.
• Excellent verbal, written, and interpersonal communication; ability to work in a team.
• Knowledge of global regulatory requirements and therapeutic areas in all phases of clinical development.

Responsabilités

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH guidelines, standards and processes, and client authoring standards.
• Manage medical writing projects, including developing timelines and cross-functional communication to maintain review cycles.
• Participate in cross-functional meetings to provide input on deliverables and timelines.
• Review Protocols and Statistical Analysis Plans as appropriate.
• Participate in cross-functional process improvement initiatives and in writing SOPs.
• Manage internal and contract medical writing resources to ensure timely completion of assigned projects.

Connaissances

Medical writing

Regulatory writing

Project management

Team leadership

ICH guidelines

Formation

Bachelor's degree

Advanced degree (preferred)

Description du poste

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.