Field of work: Clinical Development
Posting Date: 12 Mar 2025
Application deadline: 12-APR-2025
Location: Ballerup 2750, , Denmark
Contract type: Permanent
Job ID: 3004
Role Description

YOUR QUALIFICATIONS

To succeed in this role, we imagine that you have the following qualifications:

• University degree in health or biological science (MSc, MD, or equivalent).
• Research experience and experience with writing publications for scientific journals.
• The ability to plan, handle, manage, structure, and write clear, concise, and audience-friendly regulatory, scientific, and medical documents fit for purpose.
• Knowledge of clinical development, GCP, scientific research methods, and applicable regulatory guidelines.
• Experience with or interest in regulatory requirements within clinical disclosure and associated disclosure tasks .
• Fluent in oral and written English and a passion for writing.
• Strong data analysis and interpretation skills

ARE YOU A SKILLED PROFESSIONAL WITH A PASSION FOR MEDICAL WRITING AND CLINICAL DISCLOSURE? LEO PHARMA IS SEEKING A TALENTED MEDICAL WRITING AND CLINICAL DISCLOSURE PROFESSIONAL TO JOIN OUR MEDICAL COMMUNICATION TEAM IN GLOBAL CLINICAL DEVELOPMENT. IN THIS ROLE, YOU WILL PLAY A CRUCIAL PART IN PLANNING, MANAGING, AND WRITING CLEAR, CONCISE, AND AUDIENCE-FRIENDLY REGULATORY, SCIENTIFIC, AND MEDICAL DOCUMENTS. YOU WILL ALSO BE PART OF ENSURING COMPLIANCE WITH DISCLOSURE REQUIREMENTS. IF YOU HAVE A STRONG BACKGROUND IN HEALTH OR BIOLOGICAL SCIENCES, EXPERIENCE IN MEDICAL WRITING, AND A COMMITMENT TO EXCELLENCE, THIS IS A PERFECT OPPORTUNITY FOR YOU!

At LEO Pharma, our mission go beyond the conventional. We’re on an ambitious path to become the leaders in medical dermatology worldwide. If you’re ready to make a difference, this role is your gateway to a world of opportunities!

YOUR ROLE

As a Medical Writing and Clinical Disclosure Professional, your objective will be to plan, handle, manage, structure, and write clear, concise, and audience-friendly regulatory, scientific, and medical documents fit for purpose. You will also provide insight and support the organization with regards to clinical disclosure.

Your main tasks will be to:

• Write and edit original regulatory, scientific, and medical documents at a professional level.
• Lead and manage the preparation of documents in cross-functional teams.
• Oversee clinical trials conducted by vendors.
• Oversee the registration of clinical trial information in relevant public data registries.
• Facilitate redaction and anonymization of clinical documents.
• Maintain accuracy of our externally facing website: leopharmatrials.com and manage the sharing of trial documents through it.
• Contribute to regulatory submissions to health authorities to fulfill obligations related to disclosure requirements.
• Participate in ongoing standardization, improvement of procedures, and development of department activities.

To succeed in this role, we imagine that you have the following qualifications:

• University degree in health or biological science (MSc, MD, or equivalent).
• Research experience and experience with writing publications for scientific journals.
• The ability to plan, handle, manage, structure, and write clear, concise, and audience-friendly regulatory, scientific, and medical documents fit for purpose.
• Knowledge of clinical development, GCP, scientific research methods, and applicable regulatory guidelines.
• Experience with or interest in regulatory requirements within clinical disclosure and associated disclosure tasks .
• Fluent in oral and written English and a passion for writing.
• Strong data analysis and interpretation skill