LEO Pharma develops, manufactures, and markets pharmaceuticals within dermatology to patients in more than 100 countries globally. Historically, LEO Pharma owes its success over the last 100 years to LEO people with a strong passion for drug development, innovation, customer focus, integrity, and adaptability.
However, dermatology is changing. Enabled by science and technology, a new era in dermatology with completely new types of treatments is advancing rapidly. This will fundamentally change the lives of millions of people who do not have the right treatment options for their skin diseases today. LEO Pharma’s ambition is to be the key driver in this change, and the company has already taken giant leaps in strengthening their position at the forefront of medical dermatology
An innovative new product candidate, Tralokinumab, which is now in phase 3, might be one solution to the patients’ medical difficulties. To help prepare the next phases, LEO Pharma is therefore looking for a Principal Medical Writer to support the Medical Communication organisation in finalising the submission dossier on Tralokinumab.
Main Roles & Responsibilities:
- Write and edit original regulatory, scientific, and medical documents fit for purpose at a professional level throughout a clinical development programme
- Lead and manage the preparation of documents in cross-functional teams
- Document lead and lead author on large and complex cross-functional project activities and, together with colleagues in other functional areas, plan and manage the preparation of this documentation
- Review regulatory, scientific, and medical documents prepared by colleagues, other departments, business partners, or vendors.
- Participate in ongoing standardisation, improvement of procedures, and development of department activities
- Support and mentor other medical writers (incl. insourced staff or external service providers) and ensure consistency and message alignment across documents or communication platforms
- Execute highly complex or specialised projects or activities
- Analyse complex issues within the medical communication discipline and significantly improve, change, or adapt existing processes, systems, or products
- Keep abreast of professional information and technology through literature, workshops, conferences, and general knowledge-sharing
Experience/Knowledge – Qualifications:
- University degree health or biological science
- Research experience, experience with writing publications for scientific journals
- Knowledge of clinical development, GCP, statistics, scientific research methods, and applicable regulatory guidelines
- The ability to plan, handle, manage, structure, and write clear, concise, and audience-friendly regulatory, scientific, and medical documents fit for purpose
- Superb command of both written and spoken English and a passion for writing
- Experience in leading the preparation of complex regulatory submissions
- Strong leadership skills and experience in leading project teams
- A good number of years' experience as a Medical Writer in the pharmaceutical industry with experience in compiling, analysing, and preparing regulatory documentation
- Experience in leading the preparation of complex regulatory submission documents
- Experience in module 2.7.4 (clinical safety summary)
- Customer focus
- Drives results
- Communicates effectively
- Builds effective teams
- Manages ambiguity
- Good sense of humour
- Passionate and enthusiastic
- Process and result-oriented – focus on agreed objectives
- Strong networker and proactive team player
- High personal drive – open-minded
Attractiveness of the Company & Position
- Leading/supervising and writing parts of pivotal submission files
- Document lead on some of LEO’s top prioritised clinical drug candidates
- A visible and influential responsibility – from early on in clinical development through trial outlines and protocols to reporting and submission
- A reputed international niche player within the pharmaceutical industry
- A job with cross-organisational cooperation and great opportunities for project work and idea generation
- Challenging assignments, flexible working conditions, and continuous personal and professional development.
- The chance to be part of a truly patient-centric organisation with high moral and ethical standards
Interviews will be conducted on an ongoing basis, so please do not hesitate to send your application, and always feel welcome to contact Peter Samuelsen, email@example.com, mobile: +45 4058 0568 for further details.
Please note that due to GDPR rules we do not accept applications/CV via e-mail.
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