Senior Medical Writer

Azur Health Science

France

Hybride

EUR 60 000 - 80 000

Plein temps

14 jours+

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Résumé du poste

A healthcare-focused organization is seeking a Senior Medical Writer to contribute to meaningful projects in the rare disease sector. This role involves preparing regulatory documents, mentoring junior writers, and interacting with client teams. Candidates should have strong leadership skills and a minimum of 3 years in regulatory writing. Opportunities for hybrid work are available. Competitive compensation offered.

Qualifications

≥ 3 years of experience in regulatory medical writing.
Worked on ≥ 2 FDA or EMA submissions.
Experience managing and mentoring writers.

Responsabilités

Prepare regulatory documents and medical communications.
Ensure project scope and timelines are managed.
Mentor and review writing of less experienced colleagues.

Connaissances

Leadership

Interpersonal communication

Scientific writing

Project management

Description du poste

Overview

Senior Medical Writer role at Azur Health Science. If you are looking for a position in a growing company where you can join the role as a Senior Medical Writer working on projects that make tangible differences in the lives of patients with rare disease, keep reading!

Role

Azur Health Science are looking for a dynamic and autonomous Senior Medical Writer to join our growing team. We need someone who is an experienced team-player and who understands and enjoys the dynamics of working in a team. You will be someone who is flexible and willing to let people learn and lead in their own way and integrate into our culture, whilst driving forward our day-to-day business.

At Azur Health Science, we are not only specialists — we are advocates. Historically, rare disease has been overlooked, often seen as too complex or unprofitable to address. Today we see incredible progress, but there is still much more to do.

Our mission is to be a part of the progress by dedicating our expertise to this field. We aim to accelerate access to life-changing treatments for patients who have waited too long. Every rare disease deserves attention. Every patient deserves hope.

Key Responsibilities

Prepare a variety of regulatory documents and some medical communications documents, acting as lead medical writer, interacting directly with client teams.
Ensure the smooth running of a project, including understanding and managing project scope, timelines and the impact of any changes or new requests.
Advise client teams regarding the medical writing content of documents, ensure compliance with SOPs and relevant national and international guidelines.
Interact directly with client teams, developing relationships and open collaboration
Mentor less experienced writers, review their writing, and provide advice to help them grow and develop.
Contribute to the external facing side of Azur Health Science by deepening your knowledge on rare diseases, writing articles or white papers for publication, and participating in team events to engage with the rare disease community.

Experience

≥ 3 years of experience in regulatory medical writing, actively writing documents.
Worked on ≥ 2 FDA or EMA submissions for marketing authorisation, ≥ 5 protocols, ≥ 3 CSRs, and ≥ 1 investigator’s brochure, briefing document, or other scientific advice document or response to agency questions.
≥ 3 years of interacting directly with clients, coordinating study teams and leading meetings relating to medical writing deliverables.
≥ 2 years of experience managing and mentoring writers.
An ability to manage several parallel projects and (sometimes) demanding timelines.
At ease with and experience of working with multiple accounts and document management systems and software.

Qualifications

An eye for detail yet an ability to let go of perfection.
Impeccable written and spoken English.
Understanding of and adaptability to different personalities and cultures.
Ability to accept different learning styles, including learning through mistakes.
At ease with communicating internally and with multiple-stakeholder client teams.

Skills & Attributes

Strong leadership and interpersonal skills with the ability to motivate and guide study teams.
Excellent interpersonal, verbal, and written communication skills with meticulous attention to detail.
Ability to manage multiple complex projects under tight timelines.
Demonstration of providing solutions and showing initiative in challenging situations.
Ability to produce clear, concise scientific writing in English.
Ability to follow and work according to the guidance and regulations of the industry, such as Good Clinical Practice and data confidentiality and privacy regulations.
Ability to synthesise data, and non-clinical and clinical concepts from a broad range of disease areas.
Ability to form strong collaborative relationships while working effectively in cross-functional, remote, geographically and culturally diverse teams.
Strong project management skills to run and organise project teams empowering them to produce multiple tasks within agreed timelines.
Ability to think through and work around problems logically in response to changing conditions.
A rare opportunity to lead a highly skilled team in a dynamic, customer-focused environment.
Work on impactful projects in rare disease and cutting-edge therapies.

Conditions